2026MilestoneAMGNThree MariTide Phase 3 studies in type 2 diabetes to start in 2026, expected during 2026 (no exact date yet). A company milestone for Amgen (MariTide (maridebart cafraglutide) for Type 2 diabetes): a step in the program rather than a decision or a data readout.More details
2026MilestoneARGXAdimanebart (ARGX-119) registrational study start in congenital myasthenic syndromes, expected during 2026 (no exact date yet). A company milestone for argenx (adimanebart (ARGX-119) for congenital myasthenic syndromes): a step in the program rather than a decision or a data readout.More details
Registrational · a study designed to support approval
When
2026 · the company gave a window, not a day
Source note
Q2 2026 PR (Jul 23, 2026) guides 2026 start; the Q1 2026 PR had said 'CMS registrational study on track to start in third quarter of 2026'. Using the less precise, more recent guidance.
2026MilestoneARGXARGX-121 (anti-IgA) Phase 2 start in IgA nephropathy, expected during 2026 (no exact date yet). A company milestone for argenx (ARGX-121 for IgA nephropathy): a step in the program rather than a decision or a data readout.More details
2026MilestoneARGXARGX-118 and ARGX-125 to enter Phase 1 in 2026, expected during 2026 (no exact date yet). A company milestone for argenx (ARGX-118 / ARGX-125 for undisclosed): a step in the program rather than a decision or a data readout.More details
2026Trial resultsBNTXBioNTech expects to report results from its Phase 2/3 study of Pumitamig (BNT327) for Solid tumors (NSCLC, SCLC, TNBC, CRC, gastric, others) during 2026 (no exact date yet). Phase 2/3 is a combined mid- to late-stage study.More details
2026Trial resultsCRSPCRISPR expects to report results from its Phase 1 study of CTX320 / CTX321 for Elevated lipoprotein(a) / ASCVD during 2026 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
2026ApprovalMRNAModerna expects European regulators to decide on mRNA-1010 / mFLUSIVA for Seasonal influenza, adults during 2026 (no exact date yet). An approval lets the company start selling it in that market.More details
Moderna Q2 2026 earnings release (Aug 2026). FDA approved mFLUSIVA on Aug 5, 2026 (adults 50+); the Aug 5 approval release reiterates mRNA-1010 is under review in the EU, Canada and Australia with additional submissions planned during 2026.
2026Trial resultsPFEPfizer expects to report results from its Phase 3 study of mevrometostat (PF-06821497) for 1-2L metastatic castration-resistant prostate cancer post-abiraterone (MEVPRO-1) during 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
2026MilestonePFEBerobenatide (PF-3944) 10 Phase 3 obesity studies to start in 2026, expected during 2026 (no exact date yet). A company milestone for Pfizer (berobenatide (PF'3944) for Chronic weight management and obesity comorbidities (knee OA, OSA)): a step in the program rather than a decision or a data readout.More details
Chronic weight management and obesity comorbidities (knee OA, OSA)
Stage
Phase 3 · the last stage before a drug can be approved
When
2026 · the company gave a window, not a day
Source note
Pfizer Q2 2026 earnings release (Aug 4, 2026), following June 2026 VESPER-1/2/3 Phase 2b data for the monthly GLP-1 RA peptide; part of a 20+ trial obesity program.
2026MilestonePFEPD-1xVEGF (PF'4404) pivotal study starts incl. 1L NSCLC, expected during 2026 (no exact date yet). A company milestone for Pfizer (PF-08634404 (PD-1xVEGF bispecific) for 1L squamous/non-squamous NSCLC and other tumors): a step in the program rather than a decision or a data readout.More details
2026MilestoneTAKZasocitinib regulatory submissions in plaque psoriasis (US NDA and other authorities), expected during 2026 (no exact date yet). A company milestone for Takeda Pharmaceutical Company (Zasocitinib (TAK-279) for Moderate-to-severe plaque psoriasis): a step in the program rather than a decision or a data readout.More details
H2 2026ApprovalABBVAbbVie expects the FDA to decide on SKYRIZI (risankizumab) for Moderately to severely active Crohn's disease, SC induction regimen in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.More details
Moderately to severely active Crohn's disease, SC induction regimen
Stage
sBLA
When
H2 2026 · the company gave a window, not a day
Source note
AbbVie April 27, 2026 submission release (as reproduced by StockTitan); on the Q2 2026 earnings call management said it expected approval 'this fall' with a review on track and no manufacturing concerns.
H2 2026Trial resultsACADACADIA expects to report results from its Phase 3 study of Remlifanserin (ACP-204) for Hallucinations and delusions associated with Alzheimer's disease psychosis in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Hallucinations and delusions associated with Alzheimer's disease psychosis
Stage
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Existing item is dated 2026-H2; Acadia's Q2 2026 earnings release (Aug 4, 2026) narrows the window to September–October 2026. Date left at H2 because the company's window straddles Q3/Q4. Fast Track granted July 2026; Phase 3 screening/enrollment already started.
H2 2026ApprovalACADACADIA expects European regulators to decide on DAYBUE (trofinetide) for Rett syndrome (adults and children 5 years and older) — EU in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.More details
Acadia's Q2 2026 earnings release states CHMP adopted a positive opinion recommending EU marketing authorization; the European Commission decision typically follows within about two months (timing inferred, not company-stated).
H2 2026Trial resultsACADACADIA expects to report results from its Phase 3 study of trofinetide (DAYBUE) for Rett syndrome (Japan) in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Guidance from Acadia's JPM 2026 update (Jan 13, 2026); not re-stated in the Q2 2026 release. Company window runs October 2026 through March 2027, so the date field is set to 2026-H2 only as the earliest half of that window.
H2 2026Trial resultsALNYAlnylam expects to report results from its Phase 1 study of ALN-2232 for Obesity and weight management in the second half of 2026 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
H2 2026Trial resultsALNYAlnylam expects to report results from its Phase 1/2 study of ALN-6400 for Von Willebrand disease (bleeding disorders) in the second half of 2026 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.More details
Phase 1/2 · an early study that checks safety and takes a first look at effect
When
H2 2026 · the company gave a window, not a day
Source note
existing entry ALNY|readout|2026-H2 'ALN-6400 Ph1/2 VWD' — Q2 2026 release specifies the 2H 2026 readouts are Phase 1 in healthy volunteers and Phase 2 in HHT; the VWD Phase 2 was only just initiated in Q2 2026.
H2 2026Trial resultsAMGNAmgen expects to report results from its Phase 3 study of dazodalibep for Sjogren's disease (systemic and symptomatic Phase 3 studies) in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Sjogren's disease (systemic and symptomatic Phase 3 studies)
Stage
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
On the Q2 2026 earnings call (Aug 4, 2026) Amgen said Phase 3 results from the systemic (621 patients) and symptomatic (434 patients) Sjogren's studies are 'expected later this year'.
H2 2026ApprovalAMGNAmgen expects European regulators to decide on Repatha (evolocumab) for Broader use before a first heart attack or stroke (VESALIUS-CV label expansion) in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.More details
Broader use before a first heart attack or stroke (VESALIUS-CV label expansion)
Stage
Regulatory
When
H2 2026 · the company gave a window, not a day
Source note
July 29, 2026 PR announcing positive CHMP opinion; company only says EC decision expected 'in the coming months' (timing vague, mapped to 2026-H2). EC typically acts ~2 months after CHMP.
H2 2026MilestoneAMGNTEZSPIRE Phase 3 eosinophilic esophagitis study completion, expected in the second half of 2026 (no exact date yet). A company milestone for Amgen (TEZSPIRE (tezepelumab) for Eosinophilic esophagitis): a step in the program rather than a decision or a data readout.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Q2 2026 release: 'A Phase 3 study of TEZSPIRE is ongoing in patients with eosinophilic esophagitis. Study completion is expected in H2 2026.' Note this is study completion, not an explicit topline-date guidance.
H2 2026MilestoneAMGNUPLIZNA Phase 3 CIDP study initiation, expected in the second half of 2026 (no exact date yet). A company milestone for Amgen (UPLIZNA (inebilizumab) for Chronic inflammatory demyelinating polyneuropathy): a step in the program rather than a decision or a data readout.More details
H2 2026MilestoneARWRsNDA submission to FDA for plozasiran in severe hypertriglyceridemia, expected in the second half of 2026 (no exact date yet). A company milestone for Arrowhead (Plozasiran (Redemplo) for Severe hypertriglyceridemia): a step in the program rather than a decision or a data readout.More details
Company PR (July 22, 2026): planned sNDA with U.S. FDA 'before the end of 2026,' leveraging SHASTA-3, SHASTA-4 and MUIR-3, with additional global filings to follow. A PDUFA date would follow acceptance (not yet assigned).
H2 2026Trial resultsARWRArrowhead expects to report results from its Phase 3 study of Plozasiran (Redemplo) for Mixed hyperlipidemia (supportive for sHTG filing) in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Enrollment-completion PR guided primary completion of SHASTA-3/4 and MUIR-3 in mid-2026 'with topline data expected shortly thereafter.' SHASTA-3/4 topline is out (July 2026); MUIR-3 topline had not been published as of Aug 20, 2026. H2 2026 window inferred from that company guidance.
H2 2026FDA decisionAZNThe FDA is expected to decide in the second half of 2026 (no exact date yet) whether to approve AstraZeneca’s Camizestrant (next-gen oral SERD) + CDK4/6 inhibitor for 1L HR+/HER2- advanced breast cancer with emergent ESR1 mutations. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
1L HR+/HER2- advanced breast cancer with emergent ESR1 mutations
Stage
NDA under review (PDUFA extended)
When
H2 2026 · the company gave a window, not a day
Source note
On May 27, 2026 AstraZeneca disclosed the FDA extended the PDUFA date to review additional SERENA-6 analyses (ctDNA clearance linked to longer-term outcomes); the new date was not disclosed. An April 2026 advisory committee failed to reach majority support. Trackers estimate a Q4 2026 decision.
H2 2026Trial resultsAZNAstraZeneca expects to report results from its Phase 3 study of Datopotamab deruxtecan (Datroway) + durvalumab (Imfinzi) for First-line TROP2+ non-squamous advanced NSCLC in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
H2 2026Trial resultsBEAMBeam expects to report results from its Phase 1/2 study of Risto-cel (BEAM-101) for Sickle cell disease in the second half of 2026 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.More details
H2 2026Trial resultsBEAMBeam expects to report results from its Phase 1/2 study of BEAM-301 for Glycogen storage disease type Ia (R83C) in the second half of 2026 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.More details
H2 2026ConferenceBIIBBiogen presents data on Litifilimab for Cutaneous lupus erythematosus at a medical meeting in the second half of 2026 (no exact date yet). New numbers at a conference can move the stock as much as a formal announcement.More details
Biogen Q2 2026 earnings call (July 29, 2026): management plans to present 52-week Phase 2 AMETHYST CLE data at the EADV congress (fall 2026); exact month not stated by the company in the source.
H2 2026Trial resultsBMYBristol-Myers Squibb Company expects to report results from its Phase 3 study of Milvexian (oral factor XIa inhibitor; BMS/Johnson & Johnson) for Secondary stroke prevention in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Per BioSpace's July 30, 2026 coverage of BMS Q2 earnings, LIBREXIA-STROKE findings remain expected by end of 2026. Program context: LIBREXIA-ACS was discontinued in Nov 2025 after interim futility; STROKE and AF continue.
H2 2026Trial resultsBMYBristol-Myers Squibb Company expects to report results from its Phase 3 study of Cobenfy (xanomeline-trospium) for Alzheimer's disease psychosis (ADEPT-1) in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Fierce Pharma July 30, 2026 on BMS Q2 call: full ADEPT program readouts pushed to begin in early 2027 and be spread across the year, but an ADEPT-1 interim and open-label lead-in data are possible later in 2026.
H2 2026Trial resultsBNTXBioNTech expects to report results from its Phase 3 study of gotistobart (BNT316/ONC-392, anti-CTLA-4) for Squamous non-small cell lung cancer in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
BioNTech guidance: 'First interim analysis from Stage 2 of the two-stage Phase 3 clinical trial is expected in 2026' — encoded H2 2026 as the remaining window of the guided year.
H2 2026Trial resultsBNTXBioNTech expects to report results from its Phase 2/3 study of BNT113 (FixVac mRNA immunotherapy) + pembrolizumab for Unresectable recurrent/metastatic PD-L1+, HPV16+ head and neck squamous cell carcinoma in the second half of 2026 (no exact date yet). Phase 2/3 is a combined mid- to late-stage study.More details
Unresectable recurrent/metastatic PD-L1+, HPV16+ head and neck squamous cell carcinoma
Stage
Phase 2/3 · a combined mid- to late-stage study
When
H2 2026 · the company gave a window, not a day
Source note
BioNTech FY2025 report (March 2026): 'data are expected in 2026 from the first interim analysis of the Phase 3 part'; encoded H2 2026 as the remaining window of the guided year.
H2 2026MilestoneBNTXPlanned BLA filing for trastuzumab pamirtecan (BNT323), expected in the second half of 2026 (no exact date yet). A company milestone for BioNTech (trastuzumab pamirtecan (BNT323/DB-1303) for HER2-expressing endometrial cancer (initial filing indication; breast strategy pending data)): a step in the program rather than a decision or a data readout.More details
HER2-expressing endometrial cancer (initial filing indication; breast strategy pending data)
Stage
BLA preparation (Breakthrough Therapy designation)
When
H2 2026 · the company gave a window, not a day
Source note
BioNTech and DualityBio 'plan to file a biologics license application... in 2026'; optimal regulatory path across endometrial and breast indications to be finalized on complete data. Encoded H2 2026 (remaining window).
H2 2026Trial resultsCRSPCRISPR expects to report results from its Phase 1 study of Zugocabtagene geleucel (zugo-cel, formerly CTX112) for Autoimmune (SLE, SSc, myositis, ITP, wAIHA) and B-cell malignancies in the second half of 2026 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
Autoimmune (SLE, SSc, myositis, ITP, wAIHA) and B-cell malignancies
Stage
Phase 1 · an early safety study in a small group of people
When
H2 2026 · the company gave a window, not a day
Source note
Jan 12, 2026 milestones PR: 'Updates across autoimmune disease and immuno-oncology for zugocabtagene geleucel... are expected in the second half of 2026.'
H2 2026Trial resultsCRSPCRISPR expects to report results from its Phase 2 study of CTX611 (siRNA) for Thromboembolism prevention in total knee arthroplasty in the second half of 2026 (no exact date yet). Phase 2 is the stage that tests whether the drug actually works.More details
Thromboembolism prevention in total knee arthroplasty
Stage
Phase 2 · the stage that tests whether the drug actually works
When
H2 2026 · the company gave a window, not a day
Source note
Jan 12, 2026 milestones PR: 'Top-line Phase 2 clinical data from CTX611 in patients undergoing total knee arthroplasty (TKA) are expected in the second half of 2026.'
H2 2026Trial resultsCRSPCRISPR expects to report results from its Phase 1b study of CTX310 for Severe hypertriglyceridemia / refractory hypercholesterolemia in the second half of 2026 (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
Severe hypertriglyceridemia / refractory hypercholesterolemia
Stage
Phase 1b
When
H2 2026 · the company gave a window, not a day
Source note
Q2 2026 release (Aug 3, 2026). Separate from the already-listed ESC Aug 28 durability late-breaker; Phase 1b prioritizes sHTG and refractory hypercholesterolemia.
H2 2026MilestoneCYTKAMBER-HFpEF Cohort 1 ulacamten enrollment completion, expected in the second half of 2026 (no exact date yet). A company milestone for Cytokinetics (ulacamten for heart failure with preserved ejection fraction): a step in the program rather than a decision or a data readout.More details
Phase 2 · the stage that tests whether the drug actually works
When
H2 2026 · the company gave a window, not a day
Source note
Q2 2026 results PR (Aug 6, 2026): company continues Cohort 1 of AMBER-HFpEF, Phase 2 of ulacamten in symptomatic HFpEF, with enrollment completion expected in H2 2026. COMET-HF (omecamtiv) enrollment continues through 2026.
H2 2026Trial resultsDNLIDenali expects to report results from its Phase 1/2 study of DNL593 (PTV:PGRN) for frontotemporal dementia with granulin mutations in the second half of 2026 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.More details
Phase 1/2 · an early study that checks safety and takes a first look at effect
When
H2 2026 · the company gave a window, not a day
Source note
Company guidance (Q1 2026 PR): "results are expected by the end of 2026." Note: Takeda terminated the DNL593 co-development collaboration in April 2026.
H2 2026Trial resultsEXELExelixis expects to report results from its Phase 3 study of Zanzalintinib (+ nivolumab) for Previously untreated advanced non-clear cell renal cell carcinoma in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Exelixis Q2 2026 earnings release (Aug 5, 2026): topline results expected in the second half of 2026, timing dependent on event rates; primary endpoints PFS (BIRC) and ORR vs sunitinib.
H2 2026MilestoneEXELZanzalintinib Phase 2 STELLAR-202 squamous NSCLC initiation, expected in the second half of 2026 (no exact date yet). A company milestone for Exelixis (zanzalintinib for Squamous non-small cell lung cancer): a step in the program rather than a decision or a data readout.More details
H2 2026Trial resultsGERNGeron expects to report results from its Phase 3 study of imetelstat (RYTELO) for JAK-inhibitor relapsed/refractory intermediate-2/high-risk myelofibrosis in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Prior guidance placed the interim OS analysis in 2H 2026; on the Q2 2026 call management said projected timelines are unchanged but it is evaluating a modification to the interim event threshold, calls a positive interim an upside scenario, and keeps final OS analysis in 2H 2028 as base case. Timing risk is real.
H2 2026Trial resultsGILDGilead Sciences expects to report results from its Phase 3 study of Trodelvy (sacituzumab govitecan) for Advanced or recurrent endometrial cancer in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
H2 2026Trial resultsGILDGilead Sciences expects to report results from its Phase 2 study of Emvistagrast (GS-1427); edecesertib for Inflammatory bowel disease; cutaneous lupus erythematosus in the second half of 2026 (no exact date yet). Phase 2 is the stage that tests whether the drug actually works.More details
H2 2026Trial resultsGILDGilead Sciences expects to report results from its Phase 1 study of GS-3242 injection for HIV treatment (long-acting) in the second half of 2026 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
H2 2026MilestoneGSKCamlipixant US regulatory submission planned for H2 2026, expected in the second half of 2026 (no exact date yet). A company milestone for GSK (Camlipixant (P2X3 antagonist) for Refractory chronic cough): a step in the program rather than a decision or a data readout.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
GSK guidance (company reporting reflected in 2026 SEC filings) plans US, EU, and Japan regulatory submissions for camlipixant in H2 2026, setting up a likely 2027 FDA decision.
H2 2026Trial resultsGSKGSK expects to report results from its Phase III (OCEAN) study of Exdensur (depemokimab) for Eosinophilic granulomatosis with polyangiitis in the second half of 2026 (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
H2 2026MilestoneGSKJemperli AZUR-1 US regulatory submission in dMMR locally advanced rectal cancer, expected in the second half of 2026 (no exact date yet). A company milestone for GSK (Jemperli (dostarlimab) for dMMR locally advanced rectal cancer): a step in the program rather than a decision or a data readout.More details
H2 2026FDA decisionGSKThe FDA is expected to decide in the second half of 2026 (no exact date yet) whether to approve GSK’s Jemperli (dostarlimab) for dMMR locally advanced rectal cancer. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
H2 2026Trial resultsGSKGSK expects to report results from its Phase IIb registrational (EXTEND4M) study of Cabotegravir ultra-long-acting (ViiV) for HIV pre-exposure prophylaxis in the second half of 2026 (no exact date yet). Phase IIb registrational (EXTEND4M) is a study designed to support approval.More details
H2 2026FDA decisionGSKThe FDA is expected to decide in the second half of 2026 (no exact date yet) whether to approve GSK’s Arexvy (RSVPreF3 OA) for RSV prevention, immunocompromised adults aged 18+. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
H2 2026ApprovalGSKGSK expects Japanese regulators to decide on Bepirovirsen for Chronic hepatitis B in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.More details
H2 2026MilestoneGSKBexsero infant MenB US submission; Blenrep DREAMM-8 China submission, expected in the second half of 2026 (no exact date yet). A company milestone for GSK (Bexsero; Blenrep for Meningococcal B (infants); 2L+ multiple myeloma): a step in the program rather than a decision or a data readout.More details
H2 2026MilestoneGSKMo-Rez (B7-H4 ADC) three additional Phase III starts in ovarian/endometrial cancer, expected in the second half of 2026 (no exact date yet). A company milestone for GSK (Mocertatug rezetecan (Mo-Rez) for Platinum-sensitive ovarian, 1L maintenance ovarian, 1L maintenance pMMR endometrial): a step in the program rather than a decision or a data readout.More details
H2 2026Trial resultsIMVTImmunovant expects to report results from its Phase 2 study of IMVT-1402 (anti-FcRn) for Cutaneous lupus erythematosus in the second half of 2026 (no exact date yet). Phase 2 is the stage that tests whether the drug actually works.More details
Phase 2 · the stage that tests whether the drug actually works
When
H2 2026 · the company gave a window, not a day
Source note
Fiscal Q1 update (Aug 6, 2026): topline proof-of-concept data expected in second half of calendar year 2026; D2T RA registrational program update also expected 2H 2026.
H2 2026MilestoneIMVTIMVT-1402 difficult-to-treat RA registrational program update, expected in the second half of 2026 (no exact date yet). A company milestone for Immunovant (IMVT-1402 for difficult-to-treat rheumatoid arthritis): a step in the program rather than a decision or a data readout.More details
potentially registrational · a study designed to support approval
When
H2 2026 · the company gave a window, not a day
Source note
Fiscal Q1 2027 results PR (Aug 6, 2026). The CLE PoC topline (2H26) is already tracked; this is the separate D2T RA program update guided for the same window.
H2 2026Trial resultsINCYIncyte expects to report results from its Registrational combination study study of Niktimvo (axatilimab) + ruxolitinib for Newly diagnosed chronic graft-versus-host disease in the second half of 2026 (no exact date yet). Registrational combination study is a study designed to support approval.More details
Registrational combination study · a study designed to support approval
When
H2 2026 · the company gave a window, not a day
Source note
Incyte Q2 2026 earnings release: data for the axatilimab + ruxolitinib combination in newly diagnosed chronic GVHD anticipated in the second half of 2026.
H2 2026ApprovalINCYIncyte expects European regulators to decide on Povorcitinib for Moderate to severe hidradenitis suppurativa in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.More details
H2 2026Trial resultsINCYIncyte expects to report results from its Phase 1 study of INCA033989 for mutCALR myelofibrosis (mono and with ruxolitinib) in the second half of 2026 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
Phase 1 · an early safety study in a small group of people
When
H2 2026 · the company gave a window, not a day
Source note
Q2 2026 earnings PR (Jul 28, 2026) lists this among data anticipated in the second half of 2026; the Phase 3 EXCALIBUR-ET2 study in ET was initiated mid-2026.
H2 2026MilestoneINCYINCB123667 (CDK2) Phase 3 first-line maintenance ovarian cancer start, expected in the second half of 2026 (no exact date yet). A company milestone for Incyte (INCB123667 for First-line maintenance ovarian cancer): a step in the program rather than a decision or a data readout.More details
H2 2026ApprovalINSMInsmed expects Japanese regulators to decide on BRINSUPRI (brensocatib) for Non-cystic fibrosis bronchiectasis in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.More details
H2 2026MilestoneINSMTPIP Phase 3 initiation in progressive pulmonary fibrosis, expected in the second half of 2026 (no exact date yet). A company milestone for Insmed (TPIP (treprostinil palmitil inhalation powder) for Progressive pulmonary fibrosis): a step in the program rather than a decision or a data readout.More details
H2 2026MilestoneINSMARIKAYCE ENCORE data review with Japan PMDA for label expansion in 2H 2026, expected in the second half of 2026 (no exact date yet). A company milestone for Insmed (ARIKAYCE (amikacin liposome inhalation suspension) for newly diagnosed MAC lung disease): a step in the program rather than a decision or a data readout.More details
H2 2026Trial resultsIONSIonis expects to report results from its Phase 3 study of Pelacarsen for Elevated Lp(a) / cardiovascular risk reduction in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Ionis Q2 2026 earnings release: Novartis-run HORIZON outcomes trial results anticipated in H2 2026 — the first CVOT readout for an Lp(a)-lowering therapy; major royalty/milestone driver for Ionis.
H2 2026ApprovalIOVAIovance Biotherapeutics expects UK regulators to decide on lifileucel (Amtagvi) for advanced melanoma in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.More details
H2 2026FDA decisionJNJThe FDA is expected to decide in the second half of 2026 (no exact date yet) whether to approve Johnson & Johnson’s IMAAVY (nipocalimab-aahu) for Warm autoimmune hemolytic anemia (wAIHA). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
J&J announced FDA Priority Review on April 27, 2026 (ENERGY Phase 3 data); the ~6-month priority clock implies a decision around late 2026, but J&J has not disclosed the exact PDUFA date. Would be the first approved wAIHA therapy.
H2 2026Trial resultsJNJJohnson & Johnson expects to report results from its Phase 3 study of Milvexian (oral factor XIa inhibitor; J&J/BMS) for Secondary stroke prevention in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Topline expected by end of 2026 per BMS Q2 2026 commentary (BioSpace, July 30, 2026). Shared 50/50 program with Bristol Myers Squibb — same event listed under BMY.
H2 2026Trial resultsJNJJohnson & Johnson expects to report results from its Phase 1/2 study of Icotyde (icotrokinra) for Active psoriatic arthritis in the second half of 2026 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.More details
H2 2026Trial resultsJNJJohnson & Johnson expects to report results from its Phase 3 study of Inlexzo (TAR-200) for High-risk non-muscle invasive bladder cancer in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
H2 2026Trial resultsJNJJohnson & Johnson expects to report results from its Phase 3 study of Caplyta (lumateperone) for Bipolar I mania in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
H2 2026Trial resultsKRYSKrystal Biotech expects to report results from its Phase 1 study of KB407 (inhaled HSV-1 gene therapy) for Cystic fibrosis in the second half of 2026 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
H2 2026Trial resultsKRYSKrystal Biotech expects to report results from its Phase 1 study of KB707 (intratumoral) for Gorlin syndrome (basal cell carcinomas) in the second half of 2026 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
H2 2026MilestoneKRYSKB707 inhaled KYANITE-1 final dose-expansion cohort enrollment completion, expected in the second half of 2026 (no exact date yet). A company milestone for Krystal Biotech (KB707 (inhaled) for advanced NSCLC): a step in the program rather than a decision or a data readout.More details
H2 2026MilestoneKRYSVYJUVEK additional MAA filings incl. Switzerland and Australia in 2H 2026, expected in the second half of 2026 (no exact date yet). A company milestone for Krystal Biotech (VYJUVEK (beremagene geperpavec) for dystrophic epidermolysis bullosa): a step in the program rather than a decision or a data readout.More details
H2 2026MilestoneLEGNLegend targets multiple IND filings (oncology, autoimmune) starting 2H 2026, expected in the second half of 2026 (no exact date yet). A company milestone for Legend Biotech (in vivo CAR-T / pipeline for oncology and autoimmune): a step in the program rather than a decision or a data readout.More details
From Legend's JPM 2026 business update (Jan 12, 2026, via StockTitan mirror of company PR). The Aug 11, 2026 Q2 PR gave no dated forward milestones; LB2501 in vivo CAR-T PoC already reported at EHA 2026.
H2 2026FDA decisionLLYThe FDA is expected to decide in the second half of 2026 (no exact date yet) whether to approve Eli Lilly and Company’s Tirzepatide (Mounjaro) for Reduction of major adverse cardiovascular events in type 2 diabetes. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Reduction of major adverse cardiovascular events in type 2 diabetes
Stage
sNDA under review
When
H2 2026 · the company gave a window, not a day
Source note
Prime Therapeutics' GLP-1 pipeline tracker (May 2026) says an FDA decision on the SURPASS-CVOT-based CV indication is expected mid-2026; pdufa.bio estimates Q4 2026. No exact PDUFA date has been disclosed by Lilly, and the decision may land at any point in H2 2026 — verify current status before publishing.
H2 2026Trial resultsMRKMerck & expects to report results from its Phase 3 study of sacituzumab tirumotecan (MK-2870) for Advanced/recurrent endometrial cancer (TroFuse-005) in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Advanced/recurrent endometrial cancer (TroFuse-005)
Stage
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Merck Aug 4, 2026 Q2 earnings slides list this under milestones 'expected over next six months' (Aug 2026-Jan 2027); no congress named, so H2 2026 is an approximation of that window. Topline (OS and PFS met) was announced in Q2 2026.
H2 2026Trial resultsMRNAModerna expects to report results from its Registrational study (target enrollment reached) study of mRNA-3927 for Propionic acidemia (rare metabolic disease) in the second half of 2026 (no exact date yet). Registrational study (target enrollment reached) is a study designed to support approval.More details
Registrational study (target enrollment reached) · a study designed to support approval
When
H2 2026 · the company gave a window, not a day
Source note
Moderna Q2 2026 press release: 'Moderna expects potential data in 2026' from the registrational propionic acidemia study; MMA program decision deferred until these data read out.
H2 2026MilestoneNTLALonvo-z BLA submission and anticipated FDA acceptance in hereditary angioedema, expected in the second half of 2026 (no exact date yet). A company milestone for Intellia (Lonvoguran ziclumeran (lonvo-z, NTLA-2002) for Hereditary angioedema): a step in the program rather than a decision or a data readout.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Q2 2026 PR (Aug 6, 2026): anticipates FDA acceptance of the lonvo-z BLA in H2 2026. HAELO topline (April 27, 2026) was positive: 87% attack-rate reduction vs placebo; first Phase 3 win for in vivo CRISPR editing.
H2 2026MilestoneNTLAMAGNITUDE-2 Phase 3 enrollment completion (nex-z in ATTRv-PN), expected in the second half of 2026 (no exact date yet). A company milestone for Intellia (Nexiguran ziclumeran (nex-z, NTLA-2001) for Hereditary ATTR amyloidosis with polyneuropathy): a step in the program rather than a decision or a data readout.More details
H2 2026MilestoneNVOPhase 3 starts: oral zenagamtide (Q3), SC zenagamtide CVOT and high-dose cagrilintide (Q4), expected in the second half of 2026 (no exact date yet). A company milestone for Novo Nordisk (Zenagamtide (amycretin); cagrilintide for Obesity / cardiovascular outcomes): a step in the program rather than a decision or a data readout.More details
H2 2026ConferenceNVONovo Nordisk presents data on CagriSema for Obesity / weight management (1.0/1.0 and 1.7/1.7 mg doses) at a medical meeting in the second half of 2026 (no exact date yet). New numbers at a conference can move the stock as much as a formal announcement.More details
H2 2026Trial resultsNVSNovartis expects to report results from its Phase 3 study of Pelacarsen (Lp(a)-lowering antisense; with Ionis) for Cardiovascular outcomes in patients with elevated Lp(a) and CVD in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Cardiovascular outcomes in patients with elevated Lp(a) and CVD
Stage
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Reuters (July 20, 2026) lists pelacarsen among three major Novartis readouts due in H2 2026. Novartis had guided to mid-2026 (Ionis relayed Q2 2026 timing in February 2026) and data are now considered overdue/imminent. One of the most-watched cardiology catalysts of 2026.
H2 2026Trial resultsNVSNovartis expects to report results from its Phase 3 study of Remibrutinib (oral BTK inhibitor, Rhapsido) for Relapsing multiple sclerosis in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Reuters (July 20, 2026) reports the remibrutinib MS Phase 3 readout is due in H2 2026 — one of three pivotal Novartis readouts analysts flag as critical to the stock's valuation premium.
H2 2026Trial resultsNVSNovartis expects to report results from its Phase 3 study of Del-desiran (delpacibart etedesiran; Avidity Biosciences, being acquired by Novartis) for Myotonic dystrophy type 1 (DM1) in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Del-desiran (delpacibart etedesiran; Avidity Biosciences, being acquired by Novartis)
For
Myotonic dystrophy type 1 (DM1)
Stage
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Reuters (July 20, 2026) lists del-desiran pivotal data among the H2 2026 readouts that matter for Novartis, which agreed to acquire Avidity Biosciences. Multibillion-dollar peak sales potential per the report.
H2 2026ApprovalNVSNovartis expects the FDA to decide on Cosentyx (secukinumab) for Polymyalgia rheumatica in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.More details
Novartis Q2 2026 investor presentation (Jul 21, 2026) lists Cosentyx PMR under H2 2026 regulatory decisions (US); CEO on the call said they are 'anticipating FDA approval for that indication in the second half'. US/EU/JP submissions were made in Q1 2026.
H2 2026ApprovalNVSNovartis expects the FDA to decide on Rhapsido (remibrutinib) for Chronic inducible urticaria (symptomatic dermographism) in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.More details
Q2 2026 slides list Rhapsido CIndU US decision in H2 2026 (US filing for SD cohort made in 2025). Global filings across all three CIndU subtypes (EU, JP, CN) also planned 'later this year'.
H2 2026MilestoneNVSRhapsido (remibrutinib) global filings across three CIndU subtypes (EU, JP, CN), expected in the second half of 2026 (no exact date yet). A company milestone for Novartis (Rhapsido (remibrutinib) for Chronic inducible urticaria (SD, cold, cholinergic)): a step in the program rather than a decision or a data readout.More details
Q2 2026 call (Jul 21, 2026): RemIND met primary endpoint in cold and cholinergic urticaria in Q1; slides list Rhapsido CIndU EU/JP/CN submissions in H2 2026.
H2 2026ApprovalNVSNovartis expects regulators to decide on Ianalumab (VAY736) for Sjögren's disease in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.More details
US/EU/CN/JP submissions made in Q1 2026 (NEPTUNUS-1/2); Novartis guides to a US launch in H2 2026, implying FDA action in that window. CEO on Q2 call: 'on track for a U.S. launch in Sjögren's disease in the second half'.
H2 2026Trial resultsNVSNovartis expects to report results from its Phase 2 study of Rhapsido (remibrutinib) for Hidradenitis suppurativa in the second half of 2026 (no exact date yet). Phase 2 is the stage that tests whether the drug actually works.More details
H2 2026Trial resultsNVSNovartis expects to report results from its Phase 1 study of Ianalumab (VAY736) for Immune thrombocytopenia (1L) in the second half of 2026 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
Phase 1 · an early safety study in a small group of people
When
H2 2026 · the company gave a window, not a day
Source note
Q2 2026 investor presentation; CEO said 'on track for the ITP first-line readout in the second half of 2026'. Note VAYHIA (wAIHA) missed its primary endpoint in Q1 2026.
H2 2026Trial resultsNVSNovartis expects to report results from its Phase II study of QCZ484 for Hypertension in the second half of 2026 (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
H2 2026Trial resultsNVSNovartis expects to report results from its Phase II (ASTRALS) study of VHB937 for Amyotrophic lateral sclerosis in the second half of 2026 (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
H2 2026MilestoneNVSPelacarsen US regulatory submission in Lp(a) CV risk reduction, expected in the second half of 2026 (no exact date yet). A company milestone for Novartis (Pelacarsen for Cardiovascular risk reduction in elevated Lp(a)): a step in the program rather than a decision or a data readout.More details
Q2 2026 slide 'Key innovation milestones in 2026' lists pelacarsen US submission in H2 2026, following the event-driven HORIZON readout also guided for H2 2026.
H2 2026MilestoneNVSPelabresib EU submission in myelofibrosis, expected in the second half of 2026 (no exact date yet). A company milestone for Novartis (Pelabresib for Myelofibrosis): a step in the program rather than a decision or a data readout.More details
H2 2026MilestoneNVSPhase III starts: farabursen in ADPKD and remibrutinib in food allergy, expected in the second half of 2026 (no exact date yet). A company milestone for Novartis (Farabursen; remibrutinib for ADPKD; food allergy): a step in the program rather than a decision or a data readout.More details
H2 2026MilestonePTCTFDA engagement on votoplam PIVOT-HD 24-month results in Huntington's disease, expected in the second half of 2026 (no exact date yet). A company milestone for PTC (votoplam (PTC518) for Huntington's disease): a step in the program rather than a decision or a data readout.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Company plans to engage with FDA in 2H 2026 to discuss PIVOT-HD 24-month results; outcome frames a potential accelerated path for the Novartis-partnered program.
H2 2026Trial resultsRAREUltragenyx expects to report results from its Phase 3 study of GTX-102 for Angelman syndrome (full maternal UBE3A deletion) in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
H2 2026MilestoneRAREGTX-102 Phase 2/3 Aurora enrollment completion (additional genotypes/ages), expected in the second half of 2026 (no exact date yet). A company milestone for Ultragenyx (GTX-102 for Angelman syndrome (additional genotypes and age groups)): a step in the program rather than a decision or a data readout.More details
H2 2026MilestoneRAREUX016 GNE myopathy externally funded Phase 1/2 study start, expected in the second half of 2026 (no exact date yet). A company milestone for Ultragenyx (UX016 for GNE myopathy): a step in the program rather than a decision or a data readout.More details
H2 2026MilestoneRXRXREC-4881 FDA registrational-path update in FAP, expected in the second half of 2026 (no exact date yet). A company milestone for Recursion (REC-4881 (MEK1/2 inhibitor) for familial adenomatous polyposis): a step in the program rather than a decision or a data readout.More details
H2 2026Trial resultsRXRXRecursion expects to report results from its Phase 1 study of REC-1245 (RBM39 degrader) for biomarker-enriched solid tumors and lymphoma in the second half of 2026 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
H2 2026MilestoneRXRXREC-7735 PI3Ka H1047R inhibitor Phase 1/2 start in solid tumors, expected in the second half of 2026 (no exact date yet). A company milestone for Recursion (REC-7735 for PI3Ka H1047R-mutant solid tumors): a step in the program rather than a decision or a data readout.More details
Phase 1/2 · an early study that checks safety and takes a first look at effect
When
H2 2026 · the company gave a window, not a day
Source note
Q2 2026 results PR (Aug 5, 2026): IND for AI-designed REC-7735 cleared; Phase 1/2 trial in select solid tumors expected to start in the second half of 2026.
H2 2026MilestoneRYTMSetmelanotide congenital HO substudy enrollment completion, expected in the second half of 2026 (no exact date yet). A company milestone for Rhythm (setmelanotide (IMCIVREE) for congenital hypothalamic obesity): a step in the program rather than a decision or a data readout.More details
H2 2026MilestoneRYTMRM-718 Phase 1/2 Part D enrollment completion in Prader-Willi syndrome, expected in the second half of 2026 (no exact date yet). A company milestone for Rhythm (RM-718 for Prader-Willi syndrome): a step in the program rather than a decision or a data readout.More details
H2 2026Trial resultsSMMTSummit expects to report results from its Phase 3 study of Ivonescimab for First-line metastatic squamous NSCLC in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Q2 2026 PR: squamous cohort final PFS analysis events expected to be reached in second half of 2026, with interim OS analyses planned; enrollment complete.
H2 2026Trial resultsSNYSanofi expects to report results from its Phase 3 study of Sarclisa (isatuximab) for Transplant-eligible newly diagnosed multiple myeloma in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
H2 2026MilestoneSNYEfdoralprin alfa US regulatory submission in alpha-1 antitrypsin deficiency, expected in the second half of 2026 (no exact date yet). A company milestone for Sanofi (Efdoralprin alfa for Alpha-1 antitrypsin deficiency emphysema): a step in the program rather than a decision or a data readout.More details
H2 2026FDA decisionSNYThe FDA is expected to decide in the second half of 2026 (no exact date yet) whether to approve Sanofi’s Fluzone HD / Efluelda for Influenza, adults aged 50+. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
H2 2026ApprovalSNYSanofi expects Japanese regulators to decide on Dupixent (dupilumab) for Chronic spontaneous urticaria (children); allergic fungal rhinosinusitis in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.More details
H2 2026MilestoneSNYNexviazyme US label-extension submission for infantile-onset Pompe disease, expected in the second half of 2026 (no exact date yet). A company milestone for Sanofi (Nexviazyme (avalglucosidase alfa) for Infantile-onset Pompe disease): a step in the program rather than a decision or a data readout.More details
H2 2026MilestoneSNYSP0087 rabies vaccine EU decision and US submission, expected in the second half of 2026 (no exact date yet). A company milestone for Sanofi (SP0087 for Rabies): a step in the program rather than a decision or a data readout.More details
H2 2026Trial resultsSRPTSarepta expects to report results from its Phase 1/2 study of siRNA candidates (DM1 and FSHD programs) for Myotonic dystrophy type 1; facioscapulohumeral muscular dystrophy in the second half of 2026 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.More details
Myotonic dystrophy type 1; facioscapulohumeral muscular dystrophy
Stage
Phase 1/2 · an early study that checks safety and takes a first look at effect
When
H2 2026 · the company gave a window, not a day
Source note
Per Q2 2026 earnings release (Aug 5, 2026): readouts from the multiple-ascending-dose cohorts of ongoing Phase 1/2 studies in DM1 and FSHD remain on track for 2H 2026.
H2 2026ConferenceTGTXTG presents data on ublituximab (BRIUMVI IV) for relapsing multiple sclerosis (Day 1 + Day 15 combined dosing regimen) at a medical meeting in the second half of 2026 (no exact date yet). New numbers at a conference can move the stock as much as a formal announcement.More details
H2 2026Trial resultsTGTXTG expects to report results from its Phase 1 study of azercabtagene zapreleucel (azer-cel, allogeneic CD19 CAR-T) for progressive multiple sclerosis in the second half of 2026 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
H2 2026MilestoneUTHRRalinepag NDA submission for PAH, expected in the second half of 2026 (no exact date yet). A company milestone for United (Ralinepag for Pulmonary arterial hypertension): a step in the program rather than a decision or a data readout.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2026 · the company gave a window, not a day
Source note
Company PR (May 17, 2026): intends to submit an NDA for ralinepag in PAH to FDA by the second half of 2026, after ADVANCE OUTCOMES met its primary endpoint (55% risk reduction in clinical worsening).
H2 2026Trial resultsVRTXVertex expects to report results from its Phase 2 study of inaxaplin (VX-147) for APOL1-mediated kidney disease with moderate proteinuria and with Type 2 diabetes in the second half of 2026 (no exact date yet). Phase 2 is the stage that tests whether the drug actually works.More details
H2 2026Trial resultsVRTXVertex expects to report results from its Phase 1/2 study of VX-828 for Cystic fibrosis in the second half of 2026 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.More details
H2 2026MilestoneVRTXUpdated program timelines for zimislecel and VX-017 later in 2026, expected in the second half of 2026 (no exact date yet). A company milestone for Vertex (Zimislecel (VX-880) / VX-017 for Type 1 diabetes): a step in the program rather than a decision or a data readout.More details
Oct 2026ConferenceINCYIncyte presents data on INCB161734 for Metastatic PDAC (with mFOLFOX/GemNabP) and mCRC (with cetuximab) at a medical meeting in Oct 2026 (no exact date yet). New numbers at a conference can move the stock as much as a formal announcement.More details
Oct 2026ConferenceINCYIncyte presents data on INCB123667 for Recurrent epithelial ovarian cancer at a medical meeting in Oct 2026 (no exact date yet). New numbers at a conference can move the stock as much as a formal announcement.More details
Oct 2026ConferenceINCYIncyte presents data on INCA33890 for MSS colorectal cancer at a medical meeting in Oct 2026 (no exact date yet). New numbers at a conference can move the stock as much as a formal announcement.More details
Oct 2026ConferenceIOVAIovance Biotherapeutics presents data on lifileucel (Amtagvi) / TIL therapy for undifferentiated pleomorphic sarcoma / dedifferentiated liposarcoma (UPS/DDLPS) at a medical meeting in Oct 2026 (no exact date yet). New numbers at a conference can move the stock as much as a formal announcement.More details
Results to be highlighted in an oral presentation at the European Society for Medical Oncology (ESMO) meeting in Madrid, October 23-27, 2026, per company Q2 2026 press release.
Oct 2026ConferenceIOVAIovance Biotherapeutics presents data on lifileucel (Amtagvi) + pembrolizumab for frontline advanced melanoma at a medical meeting in Oct 2026 (no exact date yet). New numbers at a conference can move the stock as much as a formal announcement.More details
Oct 2026ConferenceVRTXVertex presents data on ALYFTREK / TRIKAFTA / CF pipeline for Cystic fibrosis at a medical meeting in Oct 2026 (no exact date yet). New numbers at a conference can move the stock as much as a formal announcement.More details
Nov 2, 2026in 6dConferenceRXRXRecursion presents data on REC-4881 (MEK1/2 inhibitor) for familial adenomatous polyposis at a medical meeting on Nov 2, 2026. New numbers at a conference can move the stock as much as a formal announcement.More details
Phase 2 · the stage that tests whether the drug actually works
When
Nov 2, 2026
Source note
more precise date for existing RXRX|conference|2026-11 item. Q2 2026 PR says additional TUPELO Phase 2 safety/efficacy data contextualized with real-world data will be presented at CGA-IGC Annual Meeting, Presidential Plenary I, Nov 2, 2026. FDA registrational-path update still guided for 2H26.
Nov 14, 2026in 18dFDA decisionCYTKThe FDA is due to decide by Nov 14, 2026 whether to approve Cytokinetics’ aficamten (MYQORZO) for obstructive hypertrophic cardiomyopathy (label expansion based on MAPLE-HCM). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
obstructive hypertrophic cardiomyopathy (label expansion based on MAPLE-HCM)
Stage
sNDA under FDA review
When
Nov 14, 2026
Source note
FDA accepted the MAPLE-HCM sNDA with a PDUFA target action date of November 14, 2026; could support labeling highlighting superiority over beta-blockers.
Nov 14, 2026in 18dFDA decisionSMMTThe FDA is due to decide by Nov 14, 2026 whether to approve Summit’s Ivonescimab for EGFR-mutated locally advanced/metastatic non-squamous NSCLC after 3rd-gen EGFR TKI (with chemotherapy). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Company PR (Jan 29, 2026): FDA accepted the BLA based on Phase 3 HARMONi and set a PDUFA goal action date of November 14, 2026. First US BLA for a PD-1/VEGF bispecific. No advisory committee meeting announced as of Aug 20, 2026.
Nov 2026FDA decisionALNYThe FDA is expected to decide in Nov 2026 (no exact date yet) whether to approve Alnylam’s Cemdisiran for Generalized myasthenia gravis (anti-AChR+). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Alnylam July 30, 2026 Q2 release; same event as REGN|pdufa|2026-11 but attached to ALNY (Alnylam-discovered, Regeneron-led; EC decision anticipated H2 2027).
Nov 2026FDA decisionGSKThe FDA is expected to decide in Nov 2026 (no exact date yet) whether to approve GSK’s Neladalkib (NVL-655) for ALK-positive NSCLC, TKI-pretreated. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Nov 2026FDA decisionREGNThe FDA is expected to decide in Nov 2026 (no exact date yet) whether to approve Regeneron’s cemdisiran (C5 siRNA) for Generalized myasthenia gravis (anti-AChR antibody-positive). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Phase 3 · the last stage before a drug can be approved
When
Nov 2026 · the company gave a window, not a day
Source note
FDA accepted the NDA under Priority Review (priority review voucher used) with a target action date in November 2026; announced June 22, 2026. Would be the first siRNA approved in gMG, dosed subcutaneously every 12 weeks.
Q4 2026FDA decisionABBVThe FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve AbbVie’s RINVOQ (upadacitinib) for Non-segmental vitiligo (adults and adolescents). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
AbbVie submitted to FDA and EMA on February 3, 2026 based on the Phase 3 Viti-Up program; the EU has since approved. pdufa.bio estimates a Q4 2026 US action date; AbbVie has not disclosed the exact PDUFA date.
Q4 2026Trial resultsALKSAlkermes expects to report results from its Phase 3 study of Alixorexton (ALKS 2680) for Idiopathic hypersomnia in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Q4 2026MilestoneALKSsNDA submission for LUMRYZ in idiopathic hypersomnia by year-end 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Alkermes (LUMRYZ (sodium oxybate ER) for idiopathic hypersomnia): a step in the program rather than a decision or a data readout.More details
REVITALYZ Phase 3 topline PR (May 12, 2026), reiterated on Q2 2026 call. Note: contractual restriction bars marketing LUMRYZ for IH before March 1, 2028, regardless of approval timing.
Q4 2026Trial resultsARGXargenx expects to report results from its Registrational (EMPASSION) study of Empasiprubart (ARGX-117) for Multifocal motor neuropathy (MMN) in Q4 2026 (Oct–Dec) (no exact date yet). Registrational (EMPASSION) is a study designed to support approval.More details
Q4 2026MilestoneARGXARGX-124 (next-gen FcRn) to complete Phase 1 evaluation by end of 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for argenx (ARGX-124 for FcRn (undisclosed autoimmune)): a step in the program rather than a decision or a data readout.More details
Phase 1 · an early safety study in a small group of people
When
Q4 2026 · the company gave a window, not a day
Source note
argenx H1 2026 results PR (Jul 23, 2026) guides ARGX-124 Phase 1 completion by year-end 2026; ARGX-213 described as Phase 3 ready. Dated Q4 per 'by end of 2026'.
Q4 2026Trial resultsARWRArrowhead expects to report results from its Phase 1/2 study of ARO-ALK7 for Obesity in Q4 2026 (Oct–Dec) (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.More details
Q4 2026Trial resultsAXSMAxsome expects to report results from its Phase 3 study of Solriamfetol (Sunosi) for Binge eating disorder in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Q4 2026FDA decisionAZNThe FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve AstraZeneca’s Ultomiris (ravulizumab-cwvz) for Immunoglobulin A nephropathy (adults). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
AstraZeneca/Alexion announced FDA Priority Review based on the Phase 3 I-CAN interim analysis (43.4% placebo-adjusted proteinuria reduction); PDUFA date anticipated during Q4 2026 per the company release.
Q4 2026FDA decisionAZNThe FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve AstraZeneca’s Gefurulimab (C5 nanobody) for Generalized myasthenia gravis. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Q4 2026MilestoneBEAMRisto-cel (BEAM-101) BLA submission in sickle cell disease, as early as year-end 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Beam (Risto-cel (BEAM-101) for Sickle cell disease): a step in the program rather than a decision or a data readout.More details
Q4 2026Trial resultsBIIBBiogen expects to report results from its Phase 3 study of litifilimab (BIIB059, anti-BDCA2) for Systemic lupus erythematosus in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
Q4 2026 · the company gave a window, not a day
Source note
Biogen's Q2 2026 report (July 29, 2026) guides Phase 3 topline results from both TOPAZ SLE studies in the fourth quarter of 2026 — the company's most proximate binary pipeline event.
Q4 2026MilestoneBMRNBMN 351 DMD program update by year-end 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for BioMarin (BMN 351 for Duchenne muscular dystrophy (exon 51 skipping)): a step in the program rather than a decision or a data readout.More details
Q4 2026Trial resultsBNTXBioNTech expects to report results from its Phase 3 study of trastuzumab pamirtecan (BNT323/DB-1303, HER2 ADC) for HR+/HER2-low metastatic breast cancer in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
Q4 2026 · the company gave a window, not a day
Source note
BioNTech Q2 2026 press release: 'Primary analysis is expected in the fourth quarter 2026' — one of three guided 2026 late-stage readouts (immunomodulator, ADC, mRNA immunotherapy).
Q4 2026MilestoneCYTKsNDA filing for aficamten in non-obstructive HCM, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Cytokinetics (aficamten (MYQORZO) for non-obstructive hypertrophic cardiomyopathy): a step in the program rather than a decision or a data readout.More details
Q4 2026Trial resultsINCYIncyte expects to report results from its Phase 3 study of Povorcitinib for Moderate to severe prurigo nodularis in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Q4 2026Trial resultsINCYIncyte expects to report results from its Phase 3 study of Opzelura (ruxolitinib cream) for Mild-to-moderate hidradenitis suppurativa in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Q4 2026Trial resultsIOVAIovance Biotherapeutics expects to report results from its Phase 2 study of lifileucel for post-anti-PD-1 metastatic nonsquamous NSCLC in Q4 2026 (Oct–Dec) (no exact date yet). Phase 2 is the stage that tests whether the drug actually works.More details
Q4 2026Trial resultsKRYSKrystal Biotech expects to report results from its Phase 1 study of KB111 for Hailey-Hailey disease in Q4 2026 (Oct–Dec) (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
Q4 2026Trial resultsKRYSKrystal Biotech expects to report results from its Registrational (IOLITE) study of KB803 (gene therapy eye drop) for Corneal abrasions in dystrophic epidermolysis bullosa in Q4 2026 (Oct–Dec) (no exact date yet). Registrational (IOLITE) is a study designed to support approval.More details
Q4 2026Trial resultsKRYSKrystal Biotech expects to report results from its Phase 1/2 study of KB407 for cystic fibrosis in Q4 2026 (Oct–Dec) (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.More details
Phase 1/2 · an early study that checks safety and takes a first look at effect
When
Q4 2026 · the company gave a window, not a day
Source note
existing KRYS|readout|2026-H2 KB407 CF interim; Q2 2026 PR (Aug 3, 2026) says 'before year end' (mapped to Q4). FDA alignment on registrational design expected 4Q 2026 with study start 2027.
Q4 2026MilestoneKRYSKB407 FDA alignment on CF registrational study design expected 4Q 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Krystal Biotech (KB407 for cystic fibrosis): a step in the program rather than a decision or a data readout.More details
Q4 2026MilestoneKRYSKB801 EMERALD-1 neurotrophic keratitis enrollment (~60 pts) completion before year-end, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Krystal Biotech (KB801 for neurotrophic keratitis): a step in the program rather than a decision or a data readout.More details
Q4 2026Trial resultsKYMRKymera expects to report results from its Phase 2b (enrollment complete) study of KT-621 (oral STAT6 degrader) for moderate-to-severe atopic dermatitis in Q4 2026 (Oct–Dec) (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
Enrollment completed ~6 months early; topline data accelerated to "by year-end 2026" from prior mid-2027 guidance. ~200 patients, three doses vs placebo, 16 weeks.
Q4 2026Trial resultsKYMRKymera expects to report results from its Phase 1 study of KT-579 (oral IRF5 degrader) for immunology (lupus and other autoimmune diseases) in Q4 2026 (Oct–Dec) (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
Q4 2026MilestoneMDGLErvogastat/resmetirom drug-drug interaction study start, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Madrigal (Rezdiffra (resmetirom) + ervogastat for MASH combination): a step in the program rather than a decision or a data readout.More details
Q4 2026FDA decisionNVOThe FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve Novo Nordisk’s CagriSema (cagrilintide + semaglutide) for Chronic weight management (obesity/overweight). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Phase 2 · the stage that tests whether the drug actually works
When
Q4 2026 · the company gave a window, not a day
Source note
Novo filed the NDA December 18, 2025 and said the FDA is expected to review the application in 2026; catalyst trackers and coverage put the action date in Q4 2026 under a standard review clock. No exact PDUFA date has been made public.
Q4 2026FDA decisionNVOThe FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve Novo Nordisk’s Ozempic pill (oral semaglutide 25 mg) for Type 2 diabetes. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Novo Nordisk H1 2026 financial report (company announcement 48/2026, Aug 4, 2026); also listed as 'Oral semaglutide 25 mg US decision' in Q4 2026 in the anticipated R&D milestones table.
Q4 2026FDA decisionNVOThe FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve Novo Nordisk’s Sogroya (somapacitan) for Short stature in Turner syndrome. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Q4 2026MilestoneNVOEtavopivat US and EU submissions in sickle cell disease, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Novo Nordisk (Etavopivat for Sickle cell disease): a step in the program rather than a decision or a data readout.More details
Q4 2026Trial resultsNVONovo Nordisk expects to report results from its Phase 3 study of Efruxifermin for MASH, fibrosis stage 1-4 in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Q4 2026Trial resultsPCVXVaxcyte expects to report results from its Phase 3 study of VAX-31 for Invasive pneumococcal disease/pneumonia prevention, adults in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
Q4 2026 · the company gave a window, not a day
Source note
Q2 2026 update (Aug 5, 2026): topline safety, tolerability and immunogenicity data from OPUS-1 (4,049 participants) expected in fourth quarter of 2026.
Q4 2026FDA decisionPFEThe FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve Pfizer’s TALZENNA (talazoparib) + XTANDI (enzalutamide) for HRR gene-altered metastatic castration-sensitive prostate cancer. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
HRR gene-altered metastatic castration-sensitive prostate cancer
Stage
sNDA under Priority Review
When
Q4 2026 · the company gave a window, not a day
Source note
FDA granted Priority Review to the sNDA based on Phase 3 TALAPRO-3 (52% reduction in risk of radiographic progression or death). Pfizer's release states a PDUFA action date in the last quarter of 2026; no exact day disclosed.
Q4 2026FDA decisionPFEThe FDA is expected to decide in Q4 2026 (Oct–Dec) (no exact date yet) whether to approve Pfizer’s TUKYSA (tucatinib) + trastuzumab + pertuzumab for HER2-positive metastatic breast cancer. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Catalyst tracker pdufa.bio lists a Q4 2026 (estimated) FDA action date for the TUKYSA combination in HER2+ MBC. No Pfizer press release stating the date was located, so treated as an estimate.
Q4 2026MilestonePFE35-valent pneumococcal vaccine adult candidate to enter clinic by end of 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Pfizer (PCV35 (fifth-generation pneumococcal conjugate vaccine) for Pneumococcal disease, adults): a step in the program rather than a decision or a data readout.More details
Phase 1 · an early safety study in a small group of people
When
Q4 2026 · the company gave a window, not a day
Source note
Pfizer Q2 2026 earnings release (Aug 4, 2026); PCV25 (PF-07872412) pediatric pivotal Phase 3 already began in May 2026. 'By end of 2026' mapped to Q4 2026.
Q4 2026Trial resultsRAREUltragenyx expects to report results from its Phase 3 study of UX701 for Wilson disease in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Q4 2026ApprovalRYTMRhythm expects Japanese regulators to decide on IMCIVREE (setmelanotide) for Acquired hypothalamic obesity in Q4 2026 (Oct–Dec) (no exact date yet). An approval lets the company start selling it in that market.More details
existing item RYTM|approval|2026-H2 Japan IMCIVREE aHO; Q2 2026 PR (Aug 4, 2026) now frames the MHLW decision as 'by year-end 2026' (mapped to Q4 per convention).
Q4 2026MilestoneRYTMUPDATE: Bivamelagon pivotal Phase 3 in acquired HO to start by year-end 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Rhythm (Bivamelagon (LB54640) for Acquired hypothalamic obesity): a step in the program rather than a decision or a data readout.More details
Q4 2026MilestoneSRPTELEVIDYS ENDEAVOR Cohort 8 full enrollment expected by year-end 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Sarepta (ELEVIDYS (delandistrogene moxeparvovec) for Duchenne muscular dystrophy): a step in the program rather than a decision or a data readout.More details
Q2 2026 earnings PR (Aug 5, 2026) guides to completing enrollment of ENDEAVOR Cohort 8 by year-end 2026, ahead of the already-tracked Q1 2027 12-week data readout.
Q4 2026Trial resultsTGTXTG expects to report results from its Phase 3 study of ublituximab subcutaneous (BRIUMVI SC) for relapsing multiple sclerosis in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
Q4 2026 · the company gave a window, not a day
Source note
existing TGTX|readout|2026-Q4 SC BRIUMVI item; Q2 2026 PR (Aug 3, 2026) now guides topline to year-end 2026/first quarter 2027, i.e. may slip into 2027-Q1. Date kept at 2026-Q4 as the earliest stated window.
Q4 2026MilestoneUTHRNDA submission for treprostinil SMI (soft mist inhaler) by year-end 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for United (treprostinil SMI for PAH / pulmonary hypertension): a step in the program rather than a decision or a data readout.More details
Q2 2026 earnings release (Aug 5, 2026). Company guides 'planned filings later this year' / 'by the end of this year'; mapped to 2026-Q4 as outer bound.
Q4 2026MilestoneVKTXInitiation of Phase 3 program for oral VK2735, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Viking (VK2735 (oral) for Obesity): a step in the program rather than a decision or a data readout.More details
Q4 2026Trial resultsVRTXVertex expects to report results from its Phase 2/3 study of inaxaplin (VX-147) for APOL1-mediated kidney disease in Q4 2026 (Oct–Dec) (no exact date yet). Phase 2/3 is a combined mid- to late-stage study.More details
Vertex guides that interim-analysis data are expected in 'late 2026 or early 2027' (could slip into 2027-H1); AMPLITUDE full enrollment on track for H2 2026. Positive interim could support an accelerated approval filing.
Q4 2026MilestoneVRTXSuzetrigine DPN Phase 3 enrollment completion by end of 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Vertex (Suzetrigine (JOURNAVX) for Diabetic peripheral neuropathy): a step in the program rather than a decision or a data readout.More details
Nov 25, 2026in 29dFDA decisionSNYThe FDA is due to decide by Nov 25, 2026 whether to approve Sanofi’s Venglustat (glucosylceramide synthase inhibitor) for Type 3 Gaucher disease (GD3). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Sanofi's Q2 2026 results release states the FDA granted Priority Review to the venglustat GD3 NDA (LEAP2MONO Phase 3) with a target action date of November 25, 2026. Would be the first US treatment for the neurological manifestations of GD3.
Nov 30, 2026in 34dFDA decisionVRTXThe FDA is due to decide by Nov 30, 2026 whether to approve Vertex’s povetacicept (dual BAFF/APRIL inhibitor) for IgA nephropathy (accelerated approval). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Phase 3 · the last stage before a drug can be approved
When
Nov 30, 2026
Source note
FDA accepted the BLA (announced June 1, 2026) with a PDUFA target action date of November 30, 2026, supported by the prespecified Week-36 RAINIER interim analysis (52% UPCR reduction). Breakthrough Therapy designation in IgAN.
Dec 3, 2026in 37dFDA decisionEXELThe FDA is due to decide by Dec 3, 2026 whether to approve Exelixis’ Zanzalintinib (+ atezolizumab) for Previously treated non-MSI-high metastatic colorectal cancer. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Previously treated non-MSI-high metastatic colorectal cancer
Stage
NDA under FDA review (standard review)
When
Dec 3, 2026
Source note
FDA accepted the NDA in February 2026 with a PDUFA target action date of December 3, 2026, based on STELLAR-303, which showed a statistically significant overall survival benefit vs regorafenib.
Dec 11, 2026in 45dMilestoneTAKTakeda Capital Markets Day in Tokyo, expected on Dec 11, 2026. A company milestone for Takeda Pharmaceutical Company (Pipeline (oveporexton, rusfertide, zasocitinib, mezagitamab, fazirsiran, elritercept) for Corporate/pipeline strategy): a step in the program rather than a decision or a data readout.More details
Dec 23, 2026in 57dFDA decisionGILDThe FDA is due to decide by Dec 23, 2026 whether to approve Gilead Sciences’ anitocabtagene autoleucel (anito-cel) for Fourth-line+ relapsed/refractory multiple myeloma. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Phase 2 · the stage that tests whether the drug actually works
When
Dec 23, 2026
Source note
BLA accepted with PDUFA action date of December 23, 2026. Gilead is acquiring partner Arcellx ($7.8B deal announced Feb 23, 2026) and is preparing for a potential early-2027 launch.
Feb 2, 2027FDA decisionGILDThe FDA is due to decide by Feb 2, 2027 whether to approve Gilead Sciences’ Yeztugo (lenacapavir) 300-mg once-weekly oral tablets for HIV pre-exposure prophylaxis (PrEP). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
FDA accepted the supplemental NDA for a once-weekly oral formulation of lenacapavir for PrEP with a PDUFA target action date of February 2, 2027 (disclosed in Gilead's Q2 2026 earnings release).
Q1 2027Trial resultsBMYBristol-Myers Squibb Company expects to report results from its Phase 3 study of milvexian for Stroke prevention in atrial fibrillation (LIBREXIA-AF) in Q1 2027 (Jan–Mar) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Stroke prevention in atrial fibrillation (LIBREXIA-AF)
Stage
Phase 3 · the last stage before a drug can be approved
When
Q1 2027 · the company gave a window, not a day
Source note
existing item 'BMY|readout|2027|LIBREXIA-AF milvexian' is now more precisely guided to Q1 2027 per BMS Q2 2026 earnings commentary (Fierce Pharma, July 30, 2026); previously expected in 2026.
Q1 2027ApprovalHALOHalozyme expects the FDA to decide on amivantamab + hyaluronidase-lpuj (RYBREVANT FASPRO, uses Halozyme ENHANZE) for head and neck squamous cell carcinoma (OrigAMI-4) in Q1 2027 (Jan–Mar) (no exact date yet). An approval lets the company start selling it in that market.More details
J&J submitted the sBLA around May 2026; Halozyme management said FDA granted priority review (~6-month review clock), implying a decision around late 2026/early 2027. No exact PDUFA date has been publicly announced.
Q1 2027ApprovalINCYIncyte expects regulators to decide on Povorcitinib for Moderate to severe hidradenitis suppurativa in Q1 2027 (Jan–Mar) (no exact date yet). An approval lets the company start selling it in that market.More details
Incyte Q2 2026 earnings release: NDA accepted by FDA in Q1 2026 with potential U.S. approval and launch in the first quarter of 2027 (exact PDUFA date not publicly disclosed).
Q1 2027ApprovalINCYIncyte expects regulators to decide on Monjuvi (tafasitamab) for Newly diagnosed diffuse large B-cell lymphoma in Q1 2027 (Jan–Mar) (no exact date yet). An approval lets the company start selling it in that market.More details
Q1 2027MilestoneLLYRetatrutide US regulatory submission for obesity planned Q1 2027, expected in Q1 2027 (Jan–Mar) (no exact date yet). A company milestone for Eli Lilly and Company (Retatrutide (GIP/GLP-1/glucagon triple agonist) for Obesity / chronic weight management): a step in the program rather than a decision or a data readout.More details
Phase 3 · the last stage before a drug can be approved
When
Q1 2027 · the company gave a window, not a day
Source note
After positive Phase 3 TRIUMPH-1/-2/-3 topline results (up to ~30% average weight loss), Lilly said it is completing the CMC package and plans to submit retatrutide for US approval in Q1 2027 (reported by CNBC from company statements, July 23, 2026). An FDA decision would follow in 2027 or later depending on review designation.
Q1 2027FDA decisionNVOThe FDA is expected to decide in Q1 2027 (Jan–Mar) (no exact date yet) whether to approve Novo Nordisk’s Wegovy pill (oral semaglutide 25 mg) for MASH with F2-F3 fibrosis. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Q1 2027Trial resultsSRPTSarepta expects to report results from its Phase 1b (ENDEAVOR Cohort 8) study of ELEVIDYS (delandistrogene moxeparvovec) + immunosuppressant regimen for Duchenne muscular dystrophy (gene therapy safety/immunosuppression cohort) in Q1 2027 (Jan–Mar) (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
Q2 2026 earnings release guides full enrollment of ENDEAVOR Cohort 8 by year-end 2026 and 12-week data from the full cohort in Q1 2027 — key to ELEVIDYS's path back to broader use after 2026 safety events and label restriction to ambulatory patients.
Feb 28, 2027FDA decisionBMRNThe FDA is due to decide by Feb 28, 2027 whether to approve BioMarin’s VOXZOGO (vosoritide) for Achondroplasia in children (conversion of accelerated approval to full approval). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Achondroplasia in children (conversion of accelerated approval to full approval)
Stage
sNDA under FDA review
When
Feb 28, 2027
Source note
FDA accepted BioMarin's sNDA for full approval of VOXZOGO in children with achondroplasia with a PDUFA target action date of February 28, 2027, supported by long-term data including adult height, body proportionality, and arm span.
Feb 28, 2027FDA decisionSRPTThe FDA is due to decide by Feb 28, 2027 whether to approve Sarepta’s AMONDYS 45 (casimersen) / VYONDYS 53 (golodirsen) for Duchenne muscular dystrophy (exon 45 / exon 53 skipping). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
FDA accepted sNDAs (announced July 1, 2026) seeking conversion of accelerated approvals to traditional approval, supported by ESSENCE confirmatory data and real-world evidence; PDUFA target action date Feb 28, 2027.
H1 2027Trial resultsAMGNAmgen expects to report results from its Phase 3 study of MariTide (maridebart cafraglutide) for Chronic weight management in obesity/overweight (MARITIME-1) and obesity with Type 2 diabetes (MARITIME-2) in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Chronic weight management in obesity/overweight (MARITIME-1) and obesity with Type 2 diabetes (MARITIME-2)
Stage
Phase 3 · the last stage before a drug can be approved
When
H1 2027 · the company gave a window, not a day
Source note
Primary readouts of the 72-week MARITIME-1 (~3,500 participants) and MARITIME-2 (~999 participants) trials are reported to be expected at the start of 2027. Amgen itself has not press-released a precise readout date, calling 2026 'a year of very disciplined data generation'.
H1 2027Trial resultsARGXargenx expects to report results from its Registrational (ADVANCE-NEXT) study of Efgartigimod (Vyvgart) for Primary immune thrombocytopenia in the first half of 2027 (no exact date yet). Registrational (ADVANCE-NEXT) is a study designed to support approval.More details
H1 2027MilestoneARWRZodasiran Ph3 YOSEMITE HoFH study completion mid-2027, expected in the first half of 2027 (no exact date yet). A company milestone for Arrowhead (zodasiran for Homozygous familial hypercholesterolemia): a step in the program rather than a decision or a data readout.More details
Phase 3 · the last stage before a drug can be approved
When
H1 2027 · the company gave a window, not a day
Source note
Fiscal Q3 2026 release (Aug 4, 2026); enrollment completed mid-July 2026. 'mid-2027' mapped to 2027-H1; management said on the call that data follow in H2 2027 (outside this window).
H1 2027Trial resultsAZNAstraZeneca expects to report results from its Phase 3 study of laroprovstat (AZD0780) for Hypercholesterolemia / dyslipidaemia in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H1 2027 · the company gave a window, not a day
Source note
From AstraZeneca H1 2026 results slides (July 27, 2026) as summarized by Investing.com; AZ also guided 25 Phase III readouts over the next 18 months and six NME readouts in 2027, with puxi-sam first Phase III data in H2 2027 (outside window).
H1 2027Trial resultsBIIBBiogen expects to report results from its Phase 3 study of litifilimab (BIIB059) for Cutaneous lupus erythematosus in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
H1 2027Trial resultsBIIBBiogen expects to report results from its Phase 3 study of felzartamab (anti-CD38) for Antibody-mediated rejection in kidney transplant recipients in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
H1 2027Trial resultsBMYBristol-Myers Squibb Company expects to report results from its Phase 3 study of Cobenfy (xanomeline/trospium) for Psychosis associated with Alzheimer's disease (ADEPT-1/2/4) in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Psychosis associated with Alzheimer's disease (ADEPT-1/2/4)
Stage
Phase 3 · the last stage before a drug can be approved
When
H1 2027 · the company gave a window, not a day
Source note
CEO Chris Boerner said ADEPT program topline readouts are now anticipated to begin in early 2027 and be spread across the year, with a potential ADEPT-1 interim analysis in late 2026. Timeline slipped after site 'irregularities' in ADEPT-2 and slower enrollment/event accrual.
H1 2027Trial resultsDNLIDenali expects to report results from its Phase 2a study of DNL151 (BIIB122, LRRK2 inhibitor) for Parkinson's disease in pathogenic LRRK2 variant carriers in the first half of 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
H1 2027Trial resultsDNLIDenali expects to report results from its Early-stage clinical study of DNL628 for Alzheimer's disease in the first half of 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
H1 2027FDA decisionGSKThe FDA is expected to decide in the first half of 2027 (no exact date yet) whether to approve GSK’s Cabotegravir ultra-long-acting (ViiV) for HIV pre-exposure prophylaxis. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
H1 2027ApprovalGSKGSK expects European regulators to decide on Bepirovirsen for Chronic hepatitis B in the first half of 2027 (no exact date yet). An approval lets the company start selling it in that market.More details
H1 2027MilestoneGSKExdensur EGPA submissions (US/EU/CN/JP) and Jideytro 1L ROS1+ NSCLC US submission, expected in the first half of 2027 (no exact date yet). A company milestone for GSK (Exdensur (depemokimab); Jideytro (zidesamtinib) for EGPA; treatment-naive NSCLC): a step in the program rather than a decision or a data readout.More details
H1 2027MilestoneHALOFirst Hypercon platform clinical trial starts, expected in the first half of 2027 (no exact date yet). A company milestone for Halozyme (Hypercon high-concentration formulation platform for undisclosed partner programs (incl. Vertex collaboration)): a step in the program rather than a decision or a data readout.More details
H1 2027MilestoneINCYPovorcitinib vitiligo regulatory submissions planned, expected in the first half of 2027 (no exact date yet). A company milestone for Incyte (povorcitinib for Nonsegmental vitiligo): a step in the program rather than a decision or a data readout.More details
H1 2027MilestoneINSMTPIP Phase 3 initiation in idiopathic pulmonary fibrosis, expected in the first half of 2027 (no exact date yet). A company milestone for Insmed (TPIP (treprostinil palmitil inhalation powder) for Idiopathic pulmonary fibrosis): a step in the program rather than a decision or a data readout.More details
Phase 3 · the last stage before a drug can be approved
When
H1 2027 · the company gave a window, not a day
Source note
Q2 2026 update: Phase 3 study of TPIP in IPF anticipated to initiate in the first half of 2027. Separately, ARIKAYCE sNDA for newly diagnosed MAC lung disease was submitted July 2026; PDUFA date not yet announced.
H1 2027ApprovalIOVAIovance Biotherapeutics expects regulators to decide on lifileucel (Amtagvi) for advanced melanoma in the first half of 2027 (no exact date yet). An approval lets the company start selling it in that market.More details
H1 2027Trial resultsIOVAIovance Biotherapeutics expects to report results from its investigator-sponsored study of lifileucel for CSCC / MCC in the first half of 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
H1 2027Trial resultsJAZZJazz expects to report results from its Phase 3 study of Modeyso (dordaviprone) for Recurrent H3 K27M-mutant diffuse glioma in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
H1 2027Trial resultsKRYSKrystal Biotech expects to report results from its Phase 1/2 study of KB707 (inhaled IL-12/IL-2 immunotherapy) for Non-small cell lung cancer in the first half of 2027 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.More details
H1 2027MilestoneKYMRKT-621 Phase 3 initiation in atopic dermatitis, expected in the first half of 2027 (no exact date yet). A company milestone for Kymera (KT-621 (oral STAT6 degrader) for moderate-to-severe atopic dermatitis): a step in the program rather than a decision or a data readout.More details
H1 2027ApprovalNTLAIntellia expects regulators to decide on Lonvoguran ziclumeran (lonvo-z, NTLA-2002) for Hereditary angioedema in the first half of 2027 (no exact date yet). An approval lets the company start selling it in that market.More details
H1 2027MilestoneNVAXNuvaxovid manufacturing tech transfer to Sanofi completion ($75M milestone), expected in the first half of 2027 (no exact date yet). A company milestone for Novavax (Nuvaxovid for COVID-19): a step in the program rather than a decision or a data readout.More details
Novavax Aug 6, 2026 Q2 release: manufacturing technology transfer to Sanofi expected to complete mid-2027, triggering a $75M milestone. 'mid-2027' mapped to 2027-H1 per convention (could slip into early H2).
H1 2027ApprovalNVONovo Nordisk expects European regulators to decide on Sogroya (somapacitan) for Short stature in Turner syndrome in the first half of 2027 (no exact date yet). An approval lets the company start selling it in that market.More details
H1 2027ApprovalNVSNovartis expects the FDA to decide on Del-zota (delpacibart zotadirsen) for Duchenne muscular dystrophy (exon 44 skipping) in the first half of 2027 (no exact date yet). An approval lets the company start selling it in that market.More details
H1 2027Trial resultsNVSNovartis expects to report results from its Phase III (BEYOND) study of Zigakibart for IgA nephropathy in the first half of 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
H1 2027Trial resultsPCVXVaxcyte expects to report results from its Phase 3 study of VAX-31 for Invasive pneumococcal disease/pneumonia prevention, adults in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H1 2027 · the company gave a window, not a day
Source note
Q2 2026 update: OPUS-2 (flu co-administration) and OPUS-3 (previously vaccinated adults) data expected in first half of 2027; BLA submission planned thereafter.
H1 2027Trial resultsRAREUltragenyx expects to report results from its Phase 3 study of DTX301 for Ornithine transcarbamylase (OTC) deficiency in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H1 2027 · the company gave a window, not a day
Source note
Ultragenyx Q2 2026 earnings release: data from the second primary endpoint (treatment-burden reduction after longer follow-up) expected in the first half of 2027.
H1 2027Trial resultsRXRXRecursion expects to report results from its Phase 1 study of REC-617 (CDK7 inhibitor) for advanced solid tumors in the first half of 2027 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
H1 2027Trial resultsRXRXRecursion expects to report results from its Phase 1 study of REC-3565 (MALT1 inhibitor) for B-cell malignancies in the first half of 2027 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
H1 2027Trial resultsSMMTSummit expects to report results from its Phase 3 study of Ivonescimab for First-line metastatic non-squamous NSCLC in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
H1 2027MilestoneTAKZasocitinib psoriasis US filing in FY2026; launch targeted H1 2027, expected in the first half of 2027 (no exact date yet). A company milestone for Takeda Pharmaceutical Company (Zasocitinib (TAK-279, oral TYK2 inhibitor) for Moderate-to-severe plaque psoriasis): a step in the program rather than a decision or a data readout.More details
Phase 3 · the last stage before a drug can be approved
When
H1 2027 · the company gave a window, not a day
Source note
BioSpace (citing Takeda) reports the zasocitinib application is slated within Takeda's current fiscal year (ends March 2027) with launch expected in H1 2027, implying an FDA decision by then. Timing is company guidance at year/half precision, not a confirmed PDUFA date.
H1 2027Trial resultsVRTXVertex expects to report results from its Phase 2/3 study of Inaxaplin (VX-147) for APOL1-mediated kidney disease in the first half of 2027 (no exact date yet). Phase 2/3 is a combined mid- to late-stage study.More details
existing entry VRTX|readout|2026-Q4 'inaxaplin AMPLITUDE interim' — Q2 2026 release now guides the AMPLITUDE interim data to 'early 2027' (mapped to 2027-H1); AMPLITUDE full enrollment expected H2 2026.
May 1, 2027FDA decisionAXSMThe FDA is due to decide by May 1, 2027 whether to approve Axsome’s AXS-12 (reboxetine) for Cataplexy in narcolepsy. Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
May 13, 2027FDA decisionBMYThe FDA is due to decide by May 13, 2027 whether to approve Bristol-Myers Squibb Company’s mezigdomide for Relapsed or refractory multiple myeloma (SUCCESSOR-2). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.More details
Relapsed or refractory multiple myeloma (SUCCESSOR-2)
Stage
NDA
When
May 13, 2027
Source note
BMS July 13, 2026 release: FDA accepted the NDA for mezigdomide in combination with carfilzomib and dexamethasone based on Phase 3 SUCCESSOR-2 (52% reduction in risk of progression or death vs Kd). SUCCESSOR-1 remains ongoing.
Q2 2027MilestoneARWRPotential accelerated Redemplo sHTG launch Q2 2027 (PRV priority review), expected in Q2 2027 (Apr–Jun) (no exact date yet). A company milestone for Arrowhead (plozasiran (Redemplo) for Severe hypertriglyceridemia): a step in the program rather than a decision or a data readout.More details
Fiscal Q3 2026 call (Aug 4, 2026): sNDA to be filed before year-end 2026 using an acquired priority review voucher (6-month review), which management said could enable an sHTG launch in Q2 2027. No PDUFA date yet.
2027Trial resultsABBVAbbVie expects to report results from its Early clinical study of ABBV-1758 for Alzheimer's disease during 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
AbbVie Q2 2026 earnings call (July 31, 2026) per Investing.com/GuruFocus highlights: brain-shuttle asset with >1% CSF penetration and potential monthly SC dosing; data expected in 2027. Same call flagged oral IL-23R inhibitor ABBV-8859 psoriasis data also 'expected next year'.
2027Trial resultsALKSAlkermes expects to report results from its Phase 3 study of Alixorexton (ALKS 2680) for Narcolepsy type 1 and type 2 during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
2027MilestoneARGXVYVGART SC autoinjector launch for all approved indications, expected during 2027 (no exact date yet). A company milestone for argenx (efgartigimod (VYVGART Hytrulo autoinjector) for gMG / CIDP): a step in the program rather than a decision or a data readout.More details
2027Trial resultsAXSMAxsome expects to report results from its Phase 3 study of Solriamfetol (Sunosi) for Shift work disorder during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
2027Trial resultsBMRNBioMarin expects to report results from its Phase 2/3 study of BMN 333 for Achondroplasia during 2027 (no exact date yet). Phase 2/3 is a combined mid- to late-stage study.More details
2027ApprovalBMRNBioMarin expects the FDA to decide on VOXZOGO (vosoritide) for Hypochondroplasia during 2027 (no exact date yet). An approval lets the company start selling it in that market.More details
2027Trial resultsBMYBristol-Myers Squibb Company expects to report results from its Phase 3 study of Milvexian (oral factor XIa inhibitor; BMS/Johnson & Johnson) for Stroke prevention in atrial fibrillation during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
2027MilestoneDNLIDNL126 BLA submission and potential accelerated approval in Sanfilippo syndrome type A, expected during 2027 (no exact date yet). A company milestone for Denali (DNL126 (ETV:SGSH) for Sanfilippo syndrome type A (MPS IIIA)): a step in the program rather than a decision or a data readout.More details
Phase 1/2 · an early study that checks safety and takes a first look at effect
When
2027 · the company gave a window, not a day
Source note
Company guidance: "Denali expects a Biologics License Application (BLA) submission and potential accelerated approval for DNL126 for Sanfilippo syndrome type A in 2027" (year-level guidance only).
2027Trial resultsDNLIDenali expects to report results from its Phase 1/2 study of DNL593 (PTV:PGRN) for frontotemporal dementia-GRN during 2027 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.More details
2027Trial resultsDNLIDenali expects to report results from its Phase 1/2 study of DNL952 (ETV:GAA) for Pompe disease during 2027 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.More details
2027Trial resultsDNLIDenali expects to report results from its Phase 1 study of DNL921 (ATV:Abeta) for Alzheimer's disease during 2027 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
Phase 1 · an early safety study in a small group of people
When
2027 · the company gave a window, not a day
Source note
Q2 2026 PR (Aug 6, 2026): safety and clinical PoC data from the ongoing Phase 1/1b study of DNL921 in Alzheimer's expected in 2027. DNL628 biomarker data (H1 2027) and BEACON DNL151 (H1 2027) already tracked.
2027MilestoneGILDIslatravir/lenacapavir once-weekly oral HIV regimen filings and potential launch, expected during 2027 (no exact date yet). A company milestone for Gilead Sciences (Islatravir + lenacapavir (ISL/LEN, with Merck) for HIV-1 treatment, virologically suppressed): a step in the program rather than a decision or a data readout.More details
2027MilestoneGILDAnito-cel potential filing in second-line multiple myeloma (iMMagine-3), expected during 2027 (no exact date yet). A company milestone for Gilead Sciences (Anito-cel (anitocabtagene autoleucel) for Relapsed/refractory multiple myeloma, 2L): a step in the program rather than a decision or a data readout.More details
2027Trial resultsGILDGilead Sciences expects to report results from its Phase 3 study of Lenacapavir once-yearly IM for HIV pre-exposure prophylaxis during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
2027Trial resultsGSKGSK expects to report results from its Phase III (EMBOLD-SCLC-301) study of Risvutatug rezetecan (Ris-Rez, HS-20093) for Relapsed extensive-stage small cell lung cancer during 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
2027Trial resultsIMVTImmunovant expects to report results from its Potentially registrational study of IMVT-1402 (anti-FcRn) for Graves' disease during 2027 (no exact date yet). Potentially registrational is a study designed to support approval.More details
Potentially registrational · a study designed to support approval
When
2027 · the company gave a window, not a day
Source note
Company guidance (Aug 6, 2026): topline data from the potentially registrational Graves' trial expected in calendar year 2027 (year-level precision only).
2027ApprovalIONSIonis expects European regulators to decide on TRYNGOLZA (olezarsen) for Severe hypertriglyceridemia during 2027 (no exact date yet). An approval lets the company start selling it in that market.More details
2027MilestoneIOVAAmtagvi sBLA submission in nonsquamous NSCLC (IOV-LUN-202), expected during 2027 (no exact date yet). A company milestone for Iovance Biotherapeutics (lifileucel (Amtagvi) for post-anti-PD-1 metastatic nonsquamous NSCLC): a step in the program rather than a decision or a data readout.More details
2027Trial resultsJNJJohnson & Johnson expects to report results from its Phase 3 study of Milvexian (oral factor XIa inhibitor; J&J/BMS) for Stroke prevention in atrial fibrillation during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
2027 · the company gave a window, not a day
Source note
BMS's Q2 2026 earnings presentation guides LIBREXIA-AF topline to 2027 (year-level precision only). Shared program with BMS — same event listed under BMY.
2027Trial resultsKRYSKrystal Biotech expects to report results from its Phase 1 study of KB408 for alpha-1 antitrypsin deficiency during 2027 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
2027MilestoneKYMRGilead IND filing for KT-200 CDK2 degrader, expected during 2027 (no exact date yet). A company milestone for Kymera (KT-200 for oncology (CDK2)): a step in the program rather than a decision or a data readout.More details
Q2 2026 PR (Aug 5, 2026): Gilead exercised its exclusive license option on KT-200 in April 2026 ($45M milestone) and plans an IND filing in 2027. Same PR reiterates KT-621 BROADEN2 AD data by year-end 2026, Ph3 AD start by mid-2027, BREADTH asthma data late 2027, and KT-579 Ph1 HV data in 4Q26 (all already tracked).
2027Trial resultsLEGNLegend Biotech expects to report results from its Phase 3 study of Carvykti (ciltacabtagene autoleucel) for Newly diagnosed multiple myeloma (transplant-ineligible: CARTITUDE-5; transplant-eligible: CARTITUDE-6) during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
2027 · the company gave a window, not a day
Source note
Both J&J-partnered trials are fully enrolled but event-driven; management frames readouts as possible in 2026-2027 with no committed date. Dated 2027 as the midpoint of the guided window - treat as a floating catalyst.
2027Trial resultsMDGLMadrigal expects to report results from its Phase 3 study of Rezdiffra (resmetirom) for Compensated MASH cirrhosis (F4c) during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
2027 · the company gave a window, not a day
Source note
Q2 2026 press release (July 30, 2026): company expects the event-driven MAESTRO-NASH OUTCOMES study to read out in 2027, with events accruing in line with that timeframe. Success would add an F4c indication and support full approval in noncirrhotic MASH. Year-level precision only.
2027MilestoneNVAXNovavax C. difficile vaccine clinical entry as early as 2027, expected during 2027 (no exact date yet). A company milestone for Novavax (C. difficile vaccine candidate for Clostridioides difficile infection): a step in the program rather than a decision or a data readout.More details
Q2 2026 release: candidate advanced into pre-IND interactions with FDA and GMP manufacturing initiated, supporting potential clinical entry as early as 2027 (hedged 'as early as').
2027Trial resultsNVSNovartis expects to report results from its Phase III study of Ianalumab (VAY736) for Systemic lupus erythematosus; lupus nephritis during 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
2027Trial resultsNVSNovartis expects to report results from its Phase III CVOTs study of Leqvio (inclisiran) for ASCVD MACE reduction during 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
2027Trial resultsNVSNovartis expects to report results from its Phase III study of Kesimpta (ofatumumab) for Relapsing multiple sclerosis during 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
2027MilestonePTCTPTC303 (MSH3 splicing) clinical entry, expected during 2027 (no exact date yet). A company milestone for PTC (PTC303 for somatic expansion disorders (Huntington's disease, myotonic dystrophy)): a step in the program rather than a decision or a data readout.More details
2027Trial resultsSNYSanofi expects to report results from its Phase 3 study of Frexalimab (anti-CD40L) for Relapsing multiple sclerosis during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
2027 · the company gave a window, not a day
Source note
Sanofi's Q2 2026 milestone table lists frexalimab RMS Phase 3 data in 2027 (year-level guidance only); the event-driven FREXALT trials are scheduled to complete in 2027.
2027ApprovalSNYSanofi expects European regulators to decide on Venglustat for Gaucher disease type 3 during 2027 (no exact date yet). An approval lets the company start selling it in that market.More details
2027Trial resultsSNYSanofi expects to report results from its Phase 2 study of Brivekimig; lunsekimig for Hidradenitis suppurativa; asthma (high risk) during 2027 (no exact date yet). Phase 2 is the stage that tests whether the drug actually works.More details
2027Trial resultsSNYSanofi expects to report results from its Phase 3 study of Qfitlia (fitusiran) for Hemophilia A/B during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
2027Trial resultsSNYSanofi expects to report results from its Phase 3 study of Riliprubart for Chronic inflammatory demyelinating polyneuropathy during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
2027MilestoneSNYSarclisa transplant-eligible NDMM US submission; Sarclisa SC China decision, expected during 2027 (no exact date yet). A company milestone for Sanofi (Sarclisa (isatuximab) for Transplant-eligible newly diagnosed multiple myeloma; SC formulation): a step in the program rather than a decision or a data readout.More details
2027MilestoneSNYMyqorzo (nHCM) and Redemplo (sHTG) China submissions, expected during 2027 (no exact date yet). A company milestone for Sanofi (Myqorzo; Redemplo for Non-obstructive HCM; severe hypertriglyceridemia): a step in the program rather than a decision or a data readout.More details
2027Trial resultsSNYSanofi expects to report results from its Phase 3 study of SP0202; SP0218 for Pneumococcal disease; yellow fever during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
2027ApprovalUTHRUnited expects the FDA to decide on Tyvaso (nebulized treprostinil) for Idiopathic pulmonary fibrosis during 2027 (no exact date yet). An approval lets the company start selling it in that market.More details
sNDA submitted June 2026 with priority review requested, based on positive TETON-1 and TETON-2. PDUFA date not yet publicly announced; company anticipates potential 2027 approval (launch possibly as early as Q1 2027).
2027ApprovalUTHRUnited expects the FDA to decide on ralinepag for pulmonary arterial hypertension during 2027 (no exact date yet). An approval lets the company start selling it in that market.More details
Q2 2026 earnings release (Aug 5, 2026). NDA submitted June 2026; no PDUFA date disclosed yet (acceptance not yet announced as of Aug 21). Companion Tyvaso IPF 2027 approval already tracked.
2027Trial resultsVKTXViking expects to report results from its Phase 3 study of VK2735 (subcutaneous) for Obesity (VANQUISH-1, n~4,650) and obesity/overweight with T2D (VANQUISH-2, n~1,000) during 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Obesity (VANQUISH-1, n~4,650) and obesity/overweight with T2D (VANQUISH-2, n~1,000)
Stage
Phase 3 · the last stage before a drug can be approved
When
2027 · the company gave a window, not a day
Source note
Both 78-week trials are fully enrolled (VANQUISH-1 Nov 2025, VANQUISH-2 Mar 2026) and 'proceeding according to plan'; coverage of company guidance points to completion/data in 2027 (some coverage says late 2027). Company has not press-released a specific topline quarter, hence year precision and MEDIUM.
H2 2027Trial resultsARGXargenx expects to report results from its Registrational (UNITY) study of Efgartigimod (Vyvgart) for Sjogren's disease in the second half of 2027 (no exact date yet). Registrational (UNITY) is a study designed to support approval.More details
H2 2027Trial resultsARGXargenx expects to report results from its Registrational (EMVIGORATE, EMNERGIZE) study of Empasiprubart (ARGX-117) for Chronic inflammatory demyelinating polyneuropathy (CIDP) in the second half of 2027 (no exact date yet). Registrational (EMVIGORATE, EMNERGIZE) is a study designed to support approval.More details
H2 2027Trial resultsIONSIonis expects to report results from its Phase 3 study of Obudanersen (ION582) for Angelman syndrome in the second half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
H2 2027Trial resultsKYMRKymera expects to report results from its Phase 2b study of KT-621 (oral STAT6 degrader) for asthma in the second half of 2027 (no exact date yet). This is the first look at whether the drug did what the company hoped.More details
H2 2027Trial resultsNBIXNeurocrine Biosciences expects to report results from its Phase 3 study of Osavampator (NBI-1065845) for Major depressive disorder (adjunctive) in the second half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2027 · the company gave a window, not a day
Source note
Q2 2026 earnings release guides Phase 3 MDD readouts in 2027; on the Aug 2026 earnings call management targeted second half of 2027 for Phase 3 topline data.
H2 2027Trial resultsNBIXNeurocrine Biosciences expects to report results from its Phase 3 study of Direclidine (NBI-1117568) for Schizophrenia in the second half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details
Phase 3 · the last stage before a drug can be approved
When
H2 2027 · the company gave a window, not a day
Source note
Q2 2026 earnings release guides a 2027 Phase 3 schizophrenia readout; on the Aug 2026 earnings call management said the first Phase 3 readout is expected in the second half of 2027.
H2 2027Trial resultsPCVXVaxcyte expects to report results from its Phase 1 study of VAX-A1 for Group A Strep vaccine in the second half of 2027 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
H2 2027ApprovalREGNRegeneron expects European regulators to decide on cemdisiran (C5 siRNA) for Generalized myasthenia gravis in the second half of 2027 (no exact date yet). An approval lets the company start selling it in that market.More details
H2 2027Trial resultsRXRXRecursion expects to report results from its Phase 1 study of REC-4539 (LSD1 inhibitor) for small cell lung cancer in the second half of 2027 (no exact date yet). Phase 1 is an early safety study in a small group of people.More details
H2 2027Trial resultsUTHRUnited expects to report results from its Phase 3 study of Tyvaso (nebulized treprostinil) for Progressive pulmonary fibrosis in the second half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.More details