{"schema":"biotech.company-dossier.v1","preview":true,"service":"public-developer-preview","generatedAt":"2026-10-29T20:53:28.626Z","query":{"companies":"all","category":"oncology","limit":20,"offset":0,"catalystOffset":0},"page":{"limit":20,"offset":0,"total":9,"returned":9,"nextOffset":null},"unmatched":[],"companies":[{"ticker":"BNTX","name":"BioNTech SE","categories":["mrna","oncology"],"inCuratedUniverse":true,"sec":{"cik":null,"conformedName":null,"filingsUrl":null},"catalysts":[{"id":"064a081c0c25ddf4","type":"readout","title":"BNT162b2 Phase 3 interim: >90% efficacy","drug":"BNT162b2 (Comirnaty)","indication":"COVID-19 prevention","phase":"Phase 3","date":"2020-11-09","datePrecision":"day","dateStart":"2020-11-09","dateEnd":"2020-11-09","nctId":null,"outcome":null,"confidence":null,"summary":"BioNTech reported results from its Phase 3 study of BNT162b2 (Comirnaty) for COVID-19 prevention on Nov 9, 2020. The linked source has what the numbers showed.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":null,"sourceClass":null,"verified":true,"verifiedAt":null},{"id":"e75f07e7ba796203","type":"conference","title":"Gotistobart Phase 3 stage 1 cut risk of death 54% in squamous NSCLC at ELCC","drug":"Gotistobart (BNT316/ONC-392); pumitamig (BNT327)","indication":"Second-line or later squamous non-small cell lung cancer","phase":"Phase 3 (stage 1)","date":"2026-03-24","datePrecision":"day","dateStart":"2026-03-24","dateEnd":"2026-03-24","nctId":null,"outcome":"positive","confidence":"high","summary":"BioNTech presented data on Gotistobart (BNT316/ONC-392); pumitamig (BNT327) for Second-line or later squamous non-small cell lung cancer at a medical meeting on Mar 24, 2026. The linked source has the details.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.sec.gov/Archives/edgar/data/1776985/000177698526000021/a991260324_bntxxelcccurtai.htm","sourceClass":"regulator","verified":true,"verifiedAt":null},{"id":"ea23e9cf9a3e385d","type":"readout","title":"Trastuzumab pamirtecan met primary ORR endpoint in HER2+ endometrial cancer","drug":"Trastuzumab pamirtecan (BNT323/DB-1303)","indication":"HER2-expressing recurrent/advanced endometrial cancer","phase":"Phase 2 (of Phase 1/2a)","date":"2026-04-11","datePrecision":"day","dateStart":"2026-04-11","dateEnd":"2026-04-11","nctId":null,"outcome":"positive","confidence":"high","summary":"BioNTech reported results from its Phase 1/2 study of Trastuzumab pamirtecan (BNT323/DB-1303) for HER2-expressing recurrent/advanced endometrial cancer on Apr 11, 2026. The study met its main goal.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.sec.gov/Archives/edgar/data/1776985/000177698526000027/a991260410_tpamecdataxsgo2.htm","sourceClass":"regulator","verified":true,"verifiedAt":null},{"id":"05b88a2714378c78","type":"conference","title":"Pumitamig ROSETTA Lung-02 interim Phase 2 shows high response rates at ASCO","drug":"Pumitamig (BNT327/BMS-986545)","indication":"First-line advanced non-small cell lung cancer","phase":"Phase 2 (of Phase 2/3)","date":"2026-05-30","datePrecision":"day","dateStart":"2026-05-30","dateEnd":"2026-05-30","nctId":null,"outcome":"positive","confidence":"high","summary":"BioNTech presented data on Pumitamig (BNT327/BMS-986545) for First-line advanced non-small cell lung cancer at a medical meeting on May 30, 2026. The linked source has the details.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.stocktitan.net/news/BNTX/global-data-for-bio-n-tech-and-bristol-myers-squibb-s-pd-l1x-vegf-a-501mn1wp53yc.html","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"496fbd2c565bcbdf","type":"readout","title":"Multiple pumitamig combination data readouts expected in 2026","drug":"Pumitamig (BNT327)","indication":"Solid tumors (NSCLC, SCLC, TNBC, CRC, gastric, others)","phase":"Phase 2/3","date":"2026-06-30","datePrecision":"year","dateStart":"2026-01-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":"high","summary":"BioNTech 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/biontech-announces-second-quarter-2026-financial-results-and-corporate-update","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"8d124f86de19f447","type":"approval","title":"European Commission authorizes XFG-adapted COVID-19 vaccine for 2026-2027","drug":"Pfizer-BioNTech XFG-adapted COVID-19 vaccine (Comirnaty)","indication":"Prevention of COVID-19, ages 6 months and older","phase":"Marketed / strain update","date":"2026-07-29","datePrecision":"day","dateStart":"2026-07-29","dateEnd":"2026-07-29","nctId":null,"outcome":"approved","confidence":"high","summary":"European regulators approved BioNTech’s Pfizer-BioNTech XFG-adapted COVID-19 vaccine (Comirnaty) for Prevention of COVID-19, ages 6 months and older on Jul 29, 2026. The company can now sell it in that market.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.sec.gov/Archives/edgar/data/1776985/000177698526000047/a991covid-19xfgvariantecap.htm","sourceClass":"regulator","verified":true,"verifiedAt":null},{"id":"15f4f314a47455c5","type":"conference","title":"Gotistobart PRESERVE-003 stage 1 updated OS mini oral at WCLC 2026","drug":"Gotistobart (BNT316/ONC-392)","indication":"Metastatic squamous NSCLC after PD-(L)1 progression","phase":"Phase 3","date":"2026-09-14","datePrecision":"day","dateStart":"2026-09-14","dateEnd":"2026-09-14","nctId":null,"outcome":null,"confidence":"high","summary":"BioNTech presented data on Gotistobart (BNT316/ONC-392) for Metastatic squamous NSCLC after PD-(L)1 progression at a medical meeting on Sep 14, 2026. The linked source has the details.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.stocktitan.net/news/BNTX/bio-n-tech-highlights-late-stage-lung-cancer-pipeline-momentum-and-77v8af8n6izh.html","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"fe9f6b944d4d1055","type":"conference","title":"Pumitamig + elfetabart drozuntecan late-breaking oral at WCLC 2026","drug":"Pumitamig (BNT327) + elfetabart drozuntecan (BNT324)","indication":"Advanced/metastatic lung cancer","phase":"Phase 1/2","date":"2026-09-15","datePrecision":"day","dateStart":"2026-09-15","dateEnd":"2026-09-15","nctId":null,"outcome":null,"confidence":"high","summary":"BioNTech presented data on Pumitamig (BNT327) + elfetabart drozuntecan (BNT324) for Advanced/metastatic lung cancer at a medical meeting on Sep 15, 2026. The linked source has the details.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.stocktitan.net/news/BNTX/bio-n-tech-highlights-late-stage-lung-cancer-pipeline-momentum-and-77v8af8n6izh.html","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"988531b1a4a1c2c9","type":"readout","title":"Gotistobart (BNT316) Phase 3 interim analysis in squamous NSCLC","drug":"gotistobart (BNT316/ONC-392, anti-CTLA-4)","indication":"Squamous non-small cell lung cancer","phase":"Phase 3 (two-stage pivotal trial, Stage 2 first interim)","date":"2026-09-30","datePrecision":"half","dateStart":"2026-07-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":null,"summary":"BioNTech 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biontech.com/int/en/home/mediaroom/news/press-releases/2026/08/BioNTech-Announces-Second-Quarter-2026-Financial-Results-and-Corporate-Update.html","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"99eaca89531f7d26","type":"readout","title":"BNT113 AHEAD-MERIT Phase 3 first interim analysis in HPV16+ head and neck cancer","drug":"BNT113 (FixVac mRNA immunotherapy) + pembrolizumab","indication":"Unresectable recurrent/metastatic PD-L1+, HPV16+ head and neck squamous cell carcinoma","phase":"Phase 2/3 (AHEAD-MERIT, Phase 3 part)","date":"2026-09-30","datePrecision":"half","dateStart":"2026-07-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":null,"summary":"BioNTech 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biontech.com/int/en/home/mediaroom/news/press-releases/2026/03/biontech-announces-fourth-quarter-and-full-year-2025-financial.html","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"a674065f0883272d","type":"other","title":"Planned BLA filing for trastuzumab pamirtecan (BNT323)","drug":"trastuzumab pamirtecan (BNT323/DB-1303)","indication":"HER2-expressing endometrial cancer (initial filing indication; breast strategy pending data)","phase":"BLA preparation (Breakthrough Therapy designation)","date":"2026-09-30","datePrecision":"half","dateStart":"2026-07-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":null,"summary":"Planned 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biontech.com/int/en/home/mediaroom/news/press-releases/2026/03/biontech-announces-fourth-quarter-and-full-year-2025-financial.html","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"5ed18f0c8ecf9790","type":"readout","title":"Trastuzumab pamirtecan (BNT323) DYNASTY-Breast02 primary analysis","drug":"trastuzumab pamirtecan (BNT323/DB-1303, HER2 ADC)","indication":"HR+/HER2-low metastatic breast cancer","phase":"Phase 3 (DYNASTY-Breast02)","date":"2026-11-15","datePrecision":"quarter","dateStart":"2026-10-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":null,"summary":"BioNTech 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biontech.com/int/en/home/mediaroom/news/press-releases/2026/08/BioNTech-Announces-Second-Quarter-2026-Financial-Results-and-Corporate-Update.html","sourceClass":"company_or_other","verified":true,"verifiedAt":null}],"catalystsTotal":12,"catalystsTruncated":false,"catalystsPage":{"limit":100,"offset":0,"total":12,"nextOffset":null},"clinicalTrials":{"records":null,"reason":"not_redistributed","snapshot":{"status":"not_synced","fetchedAt":null,"ok":null,"storedStudyCount":null},"linkedNctIds":[]}},{"ticker":"EXEL","name":"Exelixis, Inc.","categories":["oncology"],"inCuratedUniverse":true,"sec":{"cik":null,"conformedName":null,"filingsUrl":null},"catalysts":[{"id":"6116a896c34cb68b","type":"other","title":"Zanzalintinib Phase 3 STELLAR-316 adjuvant MRD+ CRC initiation (mid-2026, nearing start)","drug":"zanzalintinib","indication":"Adjuvant colorectal cancer (MRD-positive, with Merck/Natera)","phase":"Phase 3 initiation","date":"2026-03-30","datePrecision":"half","dateStart":"2026-01-01","dateEnd":"2026-06-30","nctId":null,"outcome":null,"confidence":"high","summary":"Zanzalintinib Phase 3 STELLAR-316 adjuvant MRD+ CRC initiation (mid-2026, nearing start), in the first half of 2026. A company milestone for Exelixis (zanzalintinib for Adjuvant colorectal cancer (MRD-positive, with Merck/Natera)): a step in the program rather than a decision or a data readout.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://finance.yahoo.com/healthcare/articles/exelixis-announces-second-quarter-2026-200500684.html","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"793bbb1743bb8984","type":"conference","title":"CABINET ASCO 2026 subgroup: CABOMETYX improved PFS in NET regardless of function","drug":"CABOMETYX (cabozantinib)","indication":"Previously treated advanced neuroendocrine tumors","phase":"Phase 3 (subgroup analysis)","date":"2026-05-30","datePrecision":"day","dateStart":"2026-05-30","dateEnd":"2026-05-30","nctId":null,"outcome":"positive","confidence":"high","summary":"Exelixis presented data on CABOMETYX (cabozantinib) for Previously treated advanced neuroendocrine tumors at a medical meeting on May 30, 2026. The linked source has the details.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://ir.exelixis.com/news-releases/news-release-details/exelixis-announces-results-subgroup-analysis-phase-3-cabinet-0","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"dc30700fc4ece044","type":"readout","title":"STELLAR-303 missed dual primary OS endpoint in non-liver-metastases subgroup","drug":"zanzalintinib plus atezolizumab (Tecentriq)","indication":"Previously treated non-MSI-high metastatic colorectal cancer","phase":"Phase 3","date":"2026-06-22","datePrecision":"day","dateStart":"2026-06-22","dateEnd":"2026-06-22","nctId":null,"outcome":"negative","confidence":"high","summary":"Exelixis reported results from its Phase 3 study of zanzalintinib plus atezolizumab (Tecentriq) for Previously treated non-MSI-high metastatic colorectal cancer on Jun 22, 2026. The study missed its main goal.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://ir.exelixis.com/news-releases/news-release-details/exelixis-provides-update-phase-3-stellar-303-trial-evaluating","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"1145d01d1ad0d6a3","type":"other","title":"Zanzalintinib Phase 2 STELLAR-202 squamous NSCLC initiation","drug":"zanzalintinib","indication":"Squamous non-small cell lung cancer","phase":"Phase 3 initiation","date":"2026-09-30","datePrecision":"half","dateStart":"2026-07-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":"high","summary":"Zanzalintinib 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://finance.yahoo.com/healthcare/articles/exelixis-announces-second-quarter-2026-200500684.html","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"44274daa8fd5f6df","type":"readout","title":"STELLAR-304 Phase 3 topline in non-clear cell RCC","drug":"Zanzalintinib (+ nivolumab)","indication":"Previously untreated advanced non-clear cell renal cell carcinoma","phase":"Phase 3 (STELLAR-304)","date":"2026-09-30","datePrecision":"half","dateStart":"2026-07-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":null,"summary":"Exelixis 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/exelixis-announces-second-quarter-2026-financial-results-and-provides-corporate-update","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"d8e062cea901dc85","type":"pdufa","title":"PDUFA date for zanzalintinib + atezolizumab in metastatic colorectal cancer","drug":"Zanzalintinib (+ atezolizumab)","indication":"Previously treated non-MSI-high metastatic colorectal cancer","phase":"NDA under FDA review (standard review)","date":"2026-12-03","datePrecision":"day","dateStart":"2026-12-03","dateEnd":"2026-12-03","nctId":null,"outcome":null,"confidence":null,"summary":"The 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/exelixis-announces-u-s-fda-accepted-the-new-drug-application-for-zanzalintinib-in-combination-with-an-immune-checkpoint-inhibitor-for-patients-with-metastatic-colorectal-cancer","sourceClass":"secondary","verified":true,"verifiedAt":null}],"catalystsTotal":6,"catalystsTruncated":false,"catalystsPage":{"limit":100,"offset":0,"total":6,"nextOffset":null},"clinicalTrials":{"records":null,"reason":"not_redistributed","snapshot":{"status":"not_synced","fetchedAt":null,"ok":null,"storedStudyCount":null},"linkedNctIds":[]}},{"ticker":"GERN","name":"Geron Corporation","categories":["oncology"],"inCuratedUniverse":true,"sec":{"cik":null,"conformedName":null,"filingsUrl":null},"catalysts":[{"id":"26f66f1ef576428d","type":"approval","title":"FDA approval of Rytelo","drug":"Rytelo (imetelstat)","indication":"Lower-risk MDS anemia","phase":null,"date":"2024-06-06","datePrecision":"day","dateStart":"2024-06-06","dateEnd":"2024-06-06","nctId":null,"outcome":null,"confidence":null,"summary":"The FDA approved Geron’s Rytelo (imetelstat) for Lower-risk MDS anemia on Jun 6, 2024. The company can now sell it in that market.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":null,"sourceClass":null,"verified":true,"verifiedAt":null},{"id":"4d2e398e19ed6c95","type":"conference","title":"First real-world RYTELO study in LR-MDS to be presented at EHA 2026","drug":"RYTELO (imetelstat)","indication":"lower-risk myelodysplastic syndromes","phase":"real-world evidence (post-approval)","date":"2026-05-12","datePrecision":"day","dateStart":"2026-05-12","dateEnd":"2026-05-12","nctId":null,"outcome":"positive","confidence":"high","summary":"Geron presented data on RYTELO (imetelstat) for lower-risk myelodysplastic syndromes at a medical meeting on May 12, 2026. The linked source has the details.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.stocktitan.net/news/GERN/first-real-world-evidence-study-of-rytelo-imetelstat-in-lower-risk-2grct1sb2j1v.html","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"571fa508809bfd70","type":"readout","title":"IMpactMF Phase 3 interim analysis (overall survival) in relapsed/refractory myelofibrosis","drug":"imetelstat (RYTELO)","indication":"JAK-inhibitor relapsed/refractory intermediate-2/high-risk myelofibrosis","phase":"Phase 3 (enrollment complete)","date":"2026-09-30","datePrecision":"half","dateStart":"2026-07-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":null,"summary":"Geron 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.fool.com/earnings/call-transcripts/2026/08/06/geron-gern-q2-2026-earnings-call-transcript/","sourceClass":"secondary","verified":true,"verifiedAt":null}],"catalystsTotal":3,"catalystsTruncated":false,"catalystsPage":{"limit":100,"offset":0,"total":3,"nextOffset":null},"clinicalTrials":{"records":null,"reason":"not_redistributed","snapshot":{"status":"not_synced","fetchedAt":null,"ok":null,"storedStudyCount":null},"linkedNctIds":[]}},{"ticker":"INCY","name":"Incyte Corporation","categories":["oncology"],"inCuratedUniverse":true,"sec":{"cik":null,"conformedName":null,"filingsUrl":null},"catalysts":[{"id":"123a36c878082da6","type":"crl","title":"CRL for Zynyz in metastatic NSCLC over third-party fill-finish inspection","drug":"Zynyz (retifanlimab-dlwr)","indication":"Metastatic non-small cell lung cancer","phase":"Regulatory (sBLA, supported by Phase 3 POD1UM-304)","date":"2026-03-06","datePrecision":"day","dateStart":"2026-03-06","dateEnd":"2026-03-06","nctId":null,"outcome":"crl","confidence":"high","summary":"The FDA told Incyte it won’t approve Zynyz (retifanlimab-dlwr) for Metastatic non-small cell lung cancer yet (Mar 6, 2026). The letter lists what has to be fixed before the application can be approved; many drugs get there after a resubmission.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.sec.gov/Archives/edgar/data/879169/000087916926000013/incy-20260227.htm","sourceClass":"regulator","verified":true,"verifiedAt":null},{"id":"faaa311a52e632a6","type":"conference","title":"Phase 3 frontMIND: tafasitamab combo cut progression or death risk 25% in 1L DLBCL","drug":"tafasitamab (Monjuvi/Minjuvi) plus lenalidomide and R-CHOP","indication":"Previously untreated high-risk DLBCL / high-grade B-cell lymphoma","phase":"Phase 3","date":"2026-05-30","datePrecision":"day","dateStart":"2026-05-30","dateEnd":"2026-05-30","nctId":null,"outcome":"positive","confidence":"high","summary":"Incyte presented data on tafasitamab (Monjuvi/Minjuvi) plus lenalidomide and R-CHOP for Previously untreated high-risk DLBCL / high-grade B-cell lymphoma at a medical meeting on May 30, 2026. The linked source has the details.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://investor.incyte.com/news-releases/news-release-details/incytes-pivotal-frontmind-trial-showed-tafasitamab","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"631c3d8b259244d3","type":"approval","title":"EU regulatory decision on Opzelura cream for moderate atopic dermatitis","drug":"Opzelura (ruxolitinib cream)","indication":"Moderate atopic dermatitis (EU)","phase":"Regulatory (post positive CHMP opinion)","date":"2026-08-15","datePrecision":"quarter","dateStart":"2026-07-01","dateEnd":"2026-09-30","nctId":null,"outcome":"approved","confidence":"high","summary":"European regulators approved Incyte’s Opzelura (ruxolitinib cream) for Moderate atopic dermatitis (EU) in Q3 2026 (Jul–Sep). The company can now sell it in that market.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://investingnews.com/incyte-reports-second-quarter-2026-financial-results-and-provides-business-updates/","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"1edea7705cc519cf","type":"readout","title":"INCA033989 (mutCALR) Phase 1 data in treatment-naive myelofibrosis","drug":"INCA033989","indication":"mutCALR myelofibrosis (mono and with ruxolitinib)","phase":"Phase 1","date":"2026-09-30","datePrecision":"half","dateStart":"2026-07-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":"high","summary":"Incyte 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.aol.com/articles/incyte-reports-second-quarter-2026-110000000.html","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"20aaffd9e789b937","type":"readout","title":"Niktimvo + ruxolitinib data in newly diagnosed chronic GVHD","drug":"Niktimvo (axatilimab) + ruxolitinib","indication":"Newly diagnosed chronic graft-versus-host disease","phase":"Registrational combination study","date":"2026-09-30","datePrecision":"half","dateStart":"2026-07-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":null,"summary":"Incyte 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/incyte-reports-second-quarter-2026-financial-results-and-provides-business-updates","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"7e381da7b3434fac","type":"other","title":"INCB123667 (CDK2) Phase 3 first-line maintenance ovarian cancer start","drug":"INCB123667","indication":"First-line maintenance ovarian cancer","phase":"Phase 3 initiation","date":"2026-09-30","datePrecision":"half","dateStart":"2026-07-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":"high","summary":"INCB123667 (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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://investingnews.com/incyte-reports-second-quarter-2026-financial-results-and-provides-business-updates/","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"f41d97b6842a2e58","type":"approval","title":"Potential EU approval of povorcitinib in hidradenitis suppurativa","drug":"Povorcitinib","indication":"Moderate to severe hidradenitis suppurativa","phase":"Under EMA review","date":"2026-09-30","datePrecision":"half","dateStart":"2026-07-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":null,"summary":"Incyte 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/incyte-reports-second-quarter-2026-financial-results-and-provides-business-updates","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"0287f5d869e29412","type":"conference","title":"INCB161734 (KRAS G12D) Phase 1 PDAC/CRC combo data rapid orals at ESMO 2026","drug":"INCB161734","indication":"Metastatic PDAC (with mFOLFOX/GemNabP) and mCRC (with cetuximab)","phase":"Phase 1","date":"2026-10-15","datePrecision":"month","dateStart":"2026-10-01","dateEnd":"2026-10-31","nctId":null,"outcome":null,"confidence":"high","summary":"Incyte 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://investingnews.com/incyte-reports-second-quarter-2026-financial-results-and-provides-business-updates/","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"26f8d3d6da070926","type":"conference","title":"INCA33890 first-line MSS CRC Phase 1 combo data at ESMO 2026","drug":"INCA33890","indication":"MSS colorectal cancer","phase":"Phase 1","date":"2026-10-15","datePrecision":"month","dateStart":"2026-10-01","dateEnd":"2026-10-31","nctId":null,"outcome":null,"confidence":"high","summary":"Incyte 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://investingnews.com/incyte-reports-second-quarter-2026-financial-results-and-provides-business-updates/","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"c5836f567065be34","type":"conference","title":"INCB123667 + bevacizumab recurrent ovarian Phase 1 efficacy data at ESMO 2026","drug":"INCB123667","indication":"Recurrent epithelial ovarian cancer","phase":"Phase 1","date":"2026-10-15","datePrecision":"month","dateStart":"2026-10-01","dateEnd":"2026-10-31","nctId":null,"outcome":null,"confidence":"high","summary":"Incyte 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://investingnews.com/incyte-reports-second-quarter-2026-financial-results-and-provides-business-updates/","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"4a7bad086c0b765a","type":"readout","title":"TRuE-HS1/HS2 Phase 3 data for ruxolitinib cream in mild-to-moderate HS","drug":"Opzelura (ruxolitinib cream)","indication":"Mild-to-moderate hidradenitis suppurativa","phase":"Phase 3 (TRuE-HS1, TRuE-HS2)","date":"2026-11-15","datePrecision":"quarter","dateStart":"2026-10-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":null,"summary":"Incyte 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/incyte-reports-second-quarter-2026-financial-results-and-provides-business-updates","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"70c751a33dde0219","type":"readout","title":"STOP-PN1/PN2 Phase 3 data for povorcitinib in prurigo nodularis","drug":"Povorcitinib","indication":"Moderate to severe prurigo nodularis","phase":"Phase 3 (STOP-PN1, STOP-PN2)","date":"2026-11-15","datePrecision":"quarter","dateStart":"2026-10-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":null,"summary":"Incyte 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/incyte-reports-second-quarter-2026-financial-results-and-provides-business-updates","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"02c24f484d116dbb","type":"approval","title":"Potential U.S. approval of tafasitamab in first-line DLBCL","drug":"Monjuvi (tafasitamab)","indication":"Newly diagnosed diffuse large B-cell lymphoma","phase":"Supplemental application under FDA review","date":"2027-02-15","datePrecision":"quarter","dateStart":"2027-01-01","dateEnd":"2027-03-31","nctId":null,"outcome":null,"confidence":null,"summary":"Incyte 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/incyte-reports-second-quarter-2026-financial-results-and-provides-business-updates","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"e62c185f5a7fbca2","type":"approval","title":"Potential U.S. approval of povorcitinib in hidradenitis suppurativa","drug":"Povorcitinib","indication":"Moderate to severe hidradenitis suppurativa","phase":"NDA under FDA review (accepted Q1 2026)","date":"2027-02-15","datePrecision":"quarter","dateStart":"2027-01-01","dateEnd":"2027-03-31","nctId":null,"outcome":null,"confidence":null,"summary":"Incyte 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/incyte-reports-second-quarter-2026-financial-results-and-provides-business-updates","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"2e02355ccd92068a","type":"other","title":"Povorcitinib vitiligo regulatory submissions planned","drug":"povorcitinib","indication":"Nonsegmental vitiligo","phase":"Regulatory filing","date":"2027-03-30","datePrecision":"half","dateStart":"2027-01-01","dateEnd":"2027-06-30","nctId":null,"outcome":null,"confidence":"high","summary":"Povorcitinib 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/incyte-reports-first-quarter-2026-financial-results-and-provides-business-updates","sourceClass":"secondary","verified":true,"verifiedAt":null}],"catalystsTotal":15,"catalystsTruncated":false,"catalystsPage":{"limit":100,"offset":0,"total":15,"nextOffset":null},"clinicalTrials":{"records":null,"reason":"not_redistributed","snapshot":{"status":"not_synced","fetchedAt":null,"ok":null,"storedStudyCount":null},"linkedNctIds":[]}},{"ticker":"IOVA","name":"Iovance Biotherapeutics, Inc.","categories":["cell-therapy","oncology"],"inCuratedUniverse":true,"sec":{"cik":null,"conformedName":null,"filingsUrl":null},"catalysts":[{"id":"98b9978c5e35e2a2","type":"approval","title":"FDA accelerated approval of Amtagvi","drug":"Amtagvi (lifileucel)","indication":"Melanoma","phase":null,"date":"2024-02-16","datePrecision":"day","dateStart":"2024-02-16","dateEnd":"2024-02-16","nctId":null,"outcome":null,"confidence":null,"summary":"The FDA approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for Melanoma on Feb 16, 2024. The company can now sell it in that market.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":null,"sourceClass":null,"verified":true,"verifiedAt":null},{"id":"95ad2a1473daed51","type":"other","title":"FDA clears IND for IL-12 tethered TIL therapy IOV-5001","drug":"IOV-5001","indication":"Solid tumors (basket trial)","phase":"Phase 1/2 (IND cleared)","date":"2026-06-01","datePrecision":"day","dateStart":"2026-06-01","dateEnd":"2026-06-01","nctId":null,"outcome":"positive","confidence":"high","summary":"FDA clears IND for IL-12 tethered TIL therapy IOV-5001, on Jun 1, 2026. A company milestone for Iovance Biotherapeutics (IOV-5001 for Solid tumors (basket trial)): a step in the program rather than a decision or a data readout.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-announces-clearance-investigational-new","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"50c528ca794b0eb3","type":"approval","title":"Australia's TGA approves Amtagvi for previously treated advanced melanoma","drug":"Amtagvi (lifileucel)","indication":"Previously treated advanced melanoma (Australia)","phase":"Approved","date":"2026-06-03","datePrecision":"day","dateStart":"2026-06-03","dateEnd":"2026-06-03","nctId":null,"outcome":"approved","confidence":"high","summary":"Regulators approved Iovance Biotherapeutics’ Amtagvi (lifileucel) for Previously treated advanced melanoma (Australia) on Jun 3, 2026. The company can now sell it in that market.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://ir.iovance.com/news-releases/news-release-details/iovances-amtagvir-lifileucel-granted-approval-treatment-advanced","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"0b6528a4cc67d16d","type":"other","title":"FDA grants Fast Track to lifileucel in soft tissue sarcomas","drug":"Amtagvi (lifileucel)","indication":"Soft tissue sarcomas (UPS/DDLPS)","phase":"Registrational (SARATOGA)","date":"2026-08-06","datePrecision":"day","dateStart":"2026-08-06","dateEnd":"2026-08-06","nctId":null,"outcome":"positive","confidence":"high","summary":"FDA grants Fast Track to lifileucel in soft tissue sarcomas, on Aug 6, 2026. A company milestone for Iovance Biotherapeutics (Amtagvi (lifileucel) for Soft tissue sarcomas (UPS/DDLPS)): a step in the program rather than a decision or a data readout.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://ir.iovance.com/news-releases/news-release-details/iovance-biotherapeutics-reports-record-second-quarter-2026","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"7770592857171d15","type":"approval","title":"Potential UK (MHRA) approval of Amtagvi in advanced melanoma","drug":"lifileucel (Amtagvi)","indication":"advanced melanoma","phase":"Regulatory review (expedited MHRA pathway)","date":"2026-09-30","datePrecision":"half","dateStart":"2026-07-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":null,"summary":"Iovance 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/iovance-biotherapeutics-reports-record-second-quarter-2026-revenue-of-99m-business-achievements-and-corporate-updates","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"7e59cd6192336354","type":"conference","title":"SARATOGA data oral presentation at ESMO 2026","drug":"lifileucel (Amtagvi) / TIL therapy","indication":"undifferentiated pleomorphic sarcoma / dedifferentiated liposarcoma (UPS/DDLPS)","phase":"Clinical trial results","date":"2026-10-15","datePrecision":"month","dateStart":"2026-10-01","dateEnd":"2026-10-31","nctId":null,"outcome":null,"confidence":null,"summary":"Iovance 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/iovance-biotherapeutics-reports-record-second-quarter-2026-revenue-of-99m-business-achievements-and-corporate-updates","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"bddcbe520b4cd4f8","type":"conference","title":"TILVANCE-301 lifileucel + pembrolizumab frontline melanoma oral at ESMO 2026","drug":"lifileucel (Amtagvi) + pembrolizumab","indication":"frontline advanced melanoma","phase":"Phase 3","date":"2026-10-15","datePrecision":"month","dateStart":"2026-10-01","dateEnd":"2026-10-31","nctId":null,"outcome":null,"confidence":"high","summary":"Iovance 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/iovance-biotherapeutics-reports-record-second-quarter-2026-revenue-of-99m-business-achievements-and-corporate-updates","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"b80970d24244d90e","type":"readout","title":"IOV-LUN-202 NSCLC registrational program updates","drug":"lifileucel","indication":"post-anti-PD-1 metastatic nonsquamous NSCLC","phase":"Phase 2 (pivotal cohorts)","date":"2026-11-15","datePrecision":"quarter","dateStart":"2026-10-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":null,"summary":"Iovance 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/iovance-biotherapeutics-reports-record-second-quarter-2026-revenue-of-99m-business-achievements-and-corporate-updates","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"64b745109eb8f2da","type":"approval","title":"Potential Switzerland (Swissmedic) approval of Amtagvi","drug":"lifileucel (Amtagvi)","indication":"advanced melanoma","phase":"Regulatory review","date":"2027-03-30","datePrecision":"half","dateStart":"2027-01-01","dateEnd":"2027-06-30","nctId":null,"outcome":null,"confidence":null,"summary":"Iovance 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/iovance-biotherapeutics-reports-record-second-quarter-2026-revenue-of-99m-business-achievements-and-corporate-updates","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"70afe68273dbb406","type":"readout","title":"Initial lifileucel data in cutaneous SCC and Merkel cell carcinoma","drug":"lifileucel","indication":"CSCC / MCC","phase":"investigator-sponsored","date":"2027-03-30","datePrecision":"half","dateStart":"2027-01-01","dateEnd":"2027-06-30","nctId":null,"outcome":null,"confidence":"high","summary":"Iovance 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/iovance-biotherapeutics-reports-record-second-quarter-2026-revenue-of-99m-business-achievements-and-corporate-updates","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"4455fe65af213026","type":"other","title":"Amtagvi sBLA submission in nonsquamous NSCLC (IOV-LUN-202)","drug":"lifileucel (Amtagvi)","indication":"post-anti-PD-1 metastatic nonsquamous NSCLC","phase":"sBLA planned","date":"2027-06-30","datePrecision":"year","dateStart":"2027-01-01","dateEnd":"2027-12-31","nctId":null,"outcome":null,"confidence":null,"summary":"Amtagvi 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/iovance-biotherapeutics-reports-record-second-quarter-2026-revenue-of-99m-business-achievements-and-corporate-updates","sourceClass":"secondary","verified":true,"verifiedAt":null}],"catalystsTotal":11,"catalystsTruncated":false,"catalystsPage":{"limit":100,"offset":0,"total":11,"nextOffset":null},"clinicalTrials":{"records":null,"reason":"not_redistributed","snapshot":{"status":"not_synced","fetchedAt":null,"ok":null,"storedStudyCount":null},"linkedNctIds":[]}},{"ticker":"JAZZ","name":"Jazz Pharmaceuticals plc","categories":["neuro","oncology"],"inCuratedUniverse":true,"sec":{"cik":null,"conformedName":null,"filingsUrl":null},"catalysts":[{"id":"b8fe3558111df4ab","type":"other","title":"FDA accepts Ziihera 1L GEA sBLA with priority review; PDUFA Aug 25, 2026","drug":"Ziihera (zanidatamab-hrii)","indication":"1L HER2+ locally advanced or metastatic GEA","phase":"Regulatory (sBLA)","date":"2026-04-27","datePrecision":"day","dateStart":"2026-04-27","dateEnd":"2026-04-27","nctId":null,"outcome":"positive","confidence":"high","summary":"FDA accepts Ziihera 1L GEA sBLA with priority review; PDUFA Aug 25, 2026, on Apr 27, 2026. A company milestone for Jazz (Ziihera (zanidatamab-hrii) for 1L HER2+ locally advanced or metastatic GEA): a step in the program rather than a decision or a data readout.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-fda-acceptance-and-priority-0","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"4e09c76655ae9b4a","type":"conference","title":"Phase 3 HERIZON-GEA-01 Ziihera results published in NEJM","drug":"Ziihera (zanidatamab-hrii)","indication":"1L HER2+ locally advanced or metastatic GEA","phase":"Phase 3","date":"2026-05-27","datePrecision":"day","dateStart":"2026-05-27","dateEnd":"2026-05-27","nctId":null,"outcome":"positive","confidence":"high","summary":"Jazz presented data on Ziihera (zanidatamab-hrii) for 1L HER2+ locally advanced or metastatic GEA at a medical meeting on May 27, 2026. The linked source has the details.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://investor.jazzpharma.com/news-releases/news-release-details/phase-3-herizon-gea-01-results-published-new-england-journal","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"cb77366d09fd32ff","type":"readout","title":"Phase 3 LAGOON missed overall survival endpoint for Zepzelca in 2L SCLC","drug":"Zepzelca (lurbinectedin)","indication":"Relapsed (2L) metastatic small cell lung cancer","phase":"Phase 3","date":"2026-06-12","datePrecision":"day","dateStart":"2026-06-12","dateEnd":"2026-06-12","nctId":null,"outcome":"negative","confidence":"high","summary":"Jazz reported results from its Phase 3 study of Zepzelca (lurbinectedin) for Relapsed (2L) metastatic small cell lung cancer on Jun 12, 2026. The study missed its main goal.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-provides-update-zepzelcar-lurbinectedin/","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"52169715533dd6db","type":"conference","title":"Jazz presents 11 late-breaking Xywav analyses at SLEEP 2026","drug":"Xywav (calcium, magnesium, potassium, and sodium oxybates)","indication":"Narcolepsy and idiopathic hypersomnia","phase":"Post-marketing / real-world","date":"2026-06-16","datePrecision":"day","dateStart":"2026-06-16","dateEnd":"2026-06-16","nctId":null,"outcome":"positive","confidence":"high","summary":"Jazz presented data on Xywav (calcium, magnesium, potassium, and sodium oxybates) for Narcolepsy and idiopathic hypersomnia at a medical meeting on Jun 16, 2026. The linked source has the details.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-delivers-extensive-late-breaking-data-sleep","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"34fa631e3b9ffa15","type":"readout","title":"HERIZON-GEA-01 second interim OS analysis (doublet) topline","drug":"Ziihera (zanidatamab-hrii)","indication":"First-line HER2+ gastroesophageal adenocarcinoma","phase":"Phase 3 (HERIZON-GEA-01)","date":"2026-08-15","datePrecision":"quarter","dateStart":"2026-07-01","dateEnd":"2026-09-30","nctId":null,"outcome":null,"confidence":null,"summary":"Jazz reported results from its Phase 3 study of Ziihera (zanidatamab-hrii) for First-line HER2+ gastroesophageal adenocarcinoma in Q3 2026 (Jul–Sep). The linked source has what the numbers showed.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-second-quarter-2026-financial-results-302841421.html","sourceClass":"wire","verified":true,"verifiedAt":null},{"id":"6a7171a9dda37532","type":"other","title":"Zepzelca labeling supplement to remove 2L ES-SCLC indication submitted to FDA","drug":"Zepzelca (lurbinectedin)","indication":"ES-SCLC second-line","phase":"labeling supplement","date":"2026-08-15","datePrecision":"quarter","dateStart":"2026-07-01","dateEnd":"2026-09-30","nctId":null,"outcome":null,"confidence":"high","summary":"Zepzelca labeling supplement to remove 2L ES-SCLC indication submitted to FDA, in Q3 2026 (Jul–Sep). A company milestone for Jazz (Zepzelca (lurbinectedin) for ES-SCLC second-line): a step in the program rather than a decision or a data readout.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-second-quarter-2026-financial-results-302841421.html","sourceClass":"wire","verified":true,"verifiedAt":null},{"id":"e0d5b5eb5f9474aa","type":"pdufa","title":"PDUFA date for Ziihera (zanidatamab) in first-line HER2+ GEA","drug":"Ziihera (zanidatamab-hrii)","indication":"First-line HER2-positive locally advanced/metastatic gastroesophageal adenocarcinoma (combinations)","phase":"sBLA under priority review","date":"2026-08-25","datePrecision":"day","dateStart":"2026-08-25","dateEnd":"2026-08-25","nctId":null,"outcome":null,"confidence":null,"summary":"The FDA’s decision on Jazz’s Ziihera (zanidatamab-hrii) for First-line HER2-positive locally advanced/metastatic gastroesophageal adenocarcinoma (combinations) was due on Aug 25, 2026. The outcome isn’t recorded here yet — the linked source has the latest.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-fda-acceptance-and-priority-review-of-supplemental-biologics-license-application-for-ziihera-zanidatamab-hrii-combinations-in-first-line-her2-locally-advanced-or-metastatic-gea-302753741.html","sourceClass":"wire","verified":true,"verifiedAt":null},{"id":"104939b921de88e5","type":"readout","title":"Modeyso ACTION Phase 3 interim OS analysis","drug":"Modeyso (dordaviprone)","indication":"Recurrent H3 K27M-mutant diffuse glioma","phase":"Phase 3 (ACTION)","date":"2027-03-30","datePrecision":"half","dateStart":"2027-01-01","dateEnd":"2027-06-30","nctId":null,"outcome":null,"confidence":null,"summary":"Jazz 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-second-quarter-2026-financial-results-302841421.html","sourceClass":"wire","verified":true,"verifiedAt":null}],"catalystsTotal":8,"catalystsTruncated":false,"catalystsPage":{"limit":100,"offset":0,"total":8,"nextOffset":null},"clinicalTrials":{"records":null,"reason":"not_redistributed","snapshot":{"status":"not_synced","fetchedAt":null,"ok":null,"storedStudyCount":null},"linkedNctIds":[]}},{"ticker":"LEGN","name":"Legend Biotech Corporation","categories":["cell-therapy","oncology"],"inCuratedUniverse":true,"sec":{"cik":null,"conformedName":null,"filingsUrl":null},"catalysts":[{"id":"82550c84c47db971","type":"conference","title":"ASCO 2026: LB2102 first-in-human ORR 28.6% in SCLC; new CARVYKTI data","drug":"LB2102 (DLL3 CAR-T); CARVYKTI (cilta-cel)","indication":"Small cell lung cancer / LCNEC; multiple myeloma","phase":"Phase 1","date":"2026-06-01","datePrecision":"day","dateStart":"2026-06-01","dateEnd":"2026-06-01","nctId":null,"outcome":"positive","confidence":"high","summary":"Legend Biotech presented data on LB2102 (DLL3 CAR-T); CARVYKTI (cilta-cel) for Small cell lung cancer / LCNEC; multiple myeloma at a medical meeting on Jun 1, 2026. The linked source has the details.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://investors.legendbiotech.com/news-releases/news-release-details/legend-biotech-presents-first-human-lb2102-results-solid-tumors","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"2808f1ccba14d010","type":"readout","title":"LB2501 in vivo CAR-T Phase 1: 100% ORR at dose level 2 in R/R B-NHL","drug":"LB2501","indication":"Relapsed/refractory B-cell non-Hodgkin lymphoma","phase":"Phase 1","date":"2026-06-02","datePrecision":"day","dateStart":"2026-06-02","dateEnd":"2026-06-02","nctId":null,"outcome":"positive","confidence":"high","summary":"Legend Biotech reported results from its Phase 1 study of LB2501 for Relapsed/refractory B-cell non-Hodgkin lymphoma on Jun 2, 2026. The study met its main goal.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://investors.legendbiotech.com/news-releases/news-release-details/legend-biotech-announces-late-breaking-oral-presentation-eha","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"a82cd939ec5c56ad","type":"conference","title":"EHA 2026 late-breaker: LB2501 establishes in vivo CAR-T proof-of-concept","drug":"LB2501","indication":"Relapsed/refractory B-cell non-Hodgkin lymphoma","phase":"Phase 1","date":"2026-06-14","datePrecision":"day","dateStart":"2026-06-14","dateEnd":"2026-06-14","nctId":null,"outcome":"positive","confidence":"high","summary":"Legend Biotech presented data on LB2501 for Relapsed/refractory B-cell non-Hodgkin lymphoma at a medical meeting on Jun 14, 2026. The linked source has the details.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://investors.legendbiotech.com/news-releases/news-release-details/legend-biotech-establishes-clinical-proof-concept-lb2501","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"52abbd32c0b8cae5","type":"other","title":"Legend targets multiple IND filings (oncology, autoimmune) starting 2H 2026","drug":"in vivo CAR-T / pipeline","indication":"oncology and autoimmune","phase":"IND","date":"2026-09-30","datePrecision":"half","dateStart":"2026-07-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":"medium","summary":"Legend 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.stocktitan.net/news/LEGN/legend-biotech-highlights-recent-business-updates-at-44th-annual-j-p-8kdjhm3k3788.html","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"9668ef828cc34460","type":"readout","title":"CARTITUDE-5 and CARTITUDE-6 event-driven Phase 3 readouts: Carvykti in frontline multiple myeloma","drug":"Carvykti (ciltacabtagene autoleucel)","indication":"Newly diagnosed multiple myeloma (transplant-ineligible: CARTITUDE-5; transplant-eligible: CARTITUDE-6)","phase":"Phase 3","date":"2027-06-30","datePrecision":"year","dateStart":"2027-01-01","dateEnd":"2027-12-31","nctId":null,"outcome":null,"confidence":null,"summary":"Legend 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.tipranks.com/news/company-announcements/legend-biotechs-earnings-call-highlights-carvykti-surge","sourceClass":"company_or_other","verified":true,"verifiedAt":null}],"catalystsTotal":5,"catalystsTruncated":false,"catalystsPage":{"limit":100,"offset":0,"total":5,"nextOffset":null},"clinicalTrials":{"records":null,"reason":"not_redistributed","snapshot":{"status":"not_synced","fetchedAt":null,"ok":null,"storedStudyCount":null},"linkedNctIds":[]}},{"ticker":"MRK","name":"Merck & Co., Inc.","categories":["large-pharma","oncology"],"inCuratedUniverse":true,"sec":{"cik":null,"conformedName":null,"filingsUrl":null},"catalysts":[{"id":"181080cc4f5043ab","type":"readout","title":"Phase 3 LITESPARK-012 missed dual primary endpoints of PFS and OS in 1L RCC","drug":"KEYTRUDA + LENVIMA + WELIREG; MK-1308A + LENVIMA","indication":"First-line advanced clear cell renal cell carcinoma","phase":"Phase 3","date":"2026-04-21","datePrecision":"day","dateStart":"2026-04-21","dateEnd":"2026-04-21","nctId":null,"outcome":"negative","confidence":"high","summary":"Merck & reported results from its Phase 3 study of KEYTRUDA + LENVIMA + WELIREG; MK-1308A + LENVIMA for First-line advanced clear cell renal cell carcinoma on Apr 21, 2026. The study missed its main goal.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.merck.com/news/merck-and-eisai-provide-update-on-phase-3-litespark-012-trial-evaluating-first-line-combination-treatments-for-certain-patients-with-advanced-renal-cell-carcinoma-rcc/","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"9a3ba7a6504ae4e8","type":"readout","title":"Phase 3 TroFuse-005 met OS and PFS endpoints for sac-TMT in endometrial cancer","drug":"sacituzumab tirumotecan (sac-TMT, MK-2870)","indication":"Advanced or recurrent endometrial cancer","phase":"Phase 3","date":"2026-05-18","datePrecision":"day","dateStart":"2026-05-18","dateEnd":"2026-05-18","nctId":null,"outcome":"positive","confidence":"high","summary":"Merck & reported results from its Phase 3 study of sacituzumab tirumotecan (sac-TMT, MK-2870) for Advanced or recurrent endometrial cancer on May 18, 2026. The study met its main goal.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.merck.com/news/merck-announces-trofuse-005-trial-evaluating-sacituzumab-tirumotecan-sac-tmt-met-primary-endpoints-of-overall-survival-os-and-progression-free-survival-pfs-in-certain-patients-with-advanced-or-r/","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"2a1cab0a015ab32f","type":"readout","title":"Phase 3 KEYNOTE-D46/EVOKE-03 discontinued after PFS missed significance","drug":"Trodelvy (sacituzumab govitecan) + KEYTRUDA","indication":"First-line PD-L1 TPS >=50% metastatic NSCLC","phase":"Phase 3","date":"2026-06-08","datePrecision":"day","dateStart":"2026-06-08","dateEnd":"2026-06-08","nctId":null,"outcome":"negative","confidence":"high","summary":"Merck & reported results from its Phase 3 study of Trodelvy (sacituzumab govitecan) + KEYTRUDA for First-line PD-L1 TPS >=50% metastatic NSCLC on Jun 8, 2026. The study missed its main goal.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.merck.com/news/merck-and-gilead-provide-update-on-phase-3-keynote-d46-evoke-03-study/","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"288b742374574e76","type":"approval","title":"FDA approves KEYTRUDA with WELIREG for adjuvant clear cell renal cell carcinoma","drug":"KEYTRUDA (pembrolizumab) + WELIREG (belzutifan)","indication":"Adjuvant clear cell renal cell carcinoma","phase":"Regulatory (sBLA)","date":"2026-06-12","datePrecision":"day","dateStart":"2026-06-12","dateEnd":"2026-06-12","nctId":null,"outcome":"approved","confidence":"high","summary":"The FDA approved Merck &’s KEYTRUDA (pembrolizumab) + WELIREG (belzutifan) for Adjuvant clear cell renal cell carcinoma on Jun 12, 2026. The company can now sell it in that market.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.merck.com/news/fda-approves-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-welireg-belzutifan-for-adjuvant-treatment-of-certain-patients/","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"16c97c9de9355402","type":"readout","title":"Phase 3 ATLAS-UC: tulisokibart met primary and key secondary endpoints","drug":"tulisokibart (MK-7240)","indication":"Moderately to severely active ulcerative colitis","phase":"Phase 3","date":"2026-06-22","datePrecision":"day","dateStart":"2026-06-22","dateEnd":"2026-06-22","nctId":null,"outcome":"positive","confidence":"high","summary":"Merck & reported results from its Phase 3 study of tulisokibart (MK-7240) for Moderately to severely active ulcerative colitis on Jun 22, 2026. The study met its main goal.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.merck.com/news/mercks-tulisokibart-met-primary-and-key-secondary-endpoints-in-the-phase-3-atlas-uc-induction-only-study-in-patients-with-moderately-to-severely-active-ulcerative-colitis-uc/","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"4434615ede68d294","type":"approval","title":"FDA approves LIPFENDRA (enlicitide), first once-daily oral PCSK9 inhibitor","drug":"LIPFENDRA (enlicitide)","indication":"Hypercholesterolemia including HeFH","phase":"Regulatory (NDA)","date":"2026-07-16","datePrecision":"day","dateStart":"2026-07-16","dateEnd":"2026-07-16","nctId":null,"outcome":"approved","confidence":"high","summary":"The FDA approved Merck &’s LIPFENDRA (enlicitide) for Hypercholesterolemia including HeFH on Jul 16, 2026. The company can now sell it in that market.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://finance.yahoo.com/healthcare/articles/merck-lipfendra-enlicitide-first-only-104500842.html","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"9e1896cde6622218","type":"other","title":"Tulisokibart Ph3 ATLAS UC trial primary completion","drug":"tulisokibart (MK-7240)","indication":"Moderately-to-severely active ulcerative colitis","phase":"Phase 3","date":"2026-08-15","datePrecision":"month","dateStart":"2026-08-01","dateEnd":"2026-08-31","nctId":null,"outcome":null,"confidence":"medium","summary":"Tulisokibart Ph3 ATLAS UC trial primary completion, in Aug 2026. A company milestone for Merck & (tulisokibart (MK-7240) for Moderately-to-severely active ulcerative colitis): a step in the program rather than a decision or a data readout.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.merck.com/wp-content/uploads/sites/124/2026/08/2Q26-Merck-Earnings-Presentation.pdf","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"3e05a7362eef2fa2","type":"readout","title":"Phase 3 INTerpath-001 met RFS and DMFS endpoints in resected melanoma","drug":"intismeran autogene (V940/mRNA-4157) + KEYTRUDA","indication":"Adjuvant resected stage IIB-IV melanoma","phase":"Phase 3","date":"2026-08-19","datePrecision":"day","dateStart":"2026-08-19","dateEnd":"2026-08-19","nctId":null,"outcome":"positive","confidence":"high","summary":"Merck & reported results from its Phase 3 study of intismeran autogene (V940/mRNA-4157) + KEYTRUDA for Adjuvant resected stage IIB-IV melanoma on Aug 19, 2026. The study met its main goal.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://finance.yahoo.com/healthcare/articles/merck-moderna-announce-phase-3-104500208.html","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"d1b961e145090edf","type":"other","title":"Remigromig (MK-3000) Ph3 BRUNELLO DME primary completion","drug":"remigromig (MK-3000)","indication":"Diabetic macular edema","phase":"Phase 3","date":"2026-09-15","datePrecision":"month","dateStart":"2026-09-01","dateEnd":"2026-09-30","nctId":null,"outcome":null,"confidence":"high","summary":"Remigromig (MK-3000) Ph3 BRUNELLO DME primary completion, in Sep 2026. A company milestone for Merck & (remigromig (MK-3000) for Diabetic macular edema): a step in the program rather than a decision or a data readout.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.merck.com/wp-content/uploads/sites/124/2026/08/2Q26-Merck-Earnings-Presentation.pdf","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"6b63bde1a9568bc5","type":"pdufa","title":"PDUFA for WINREVAIR label update based on Phase 3 HYPERION","drug":"WINREVAIR (sotatercept-csrk)","indication":"Pulmonary arterial hypertension (recently diagnosed patients; label update)","phase":"sBLA under review","date":"2026-09-21","datePrecision":"day","dateStart":"2026-09-21","dateEnd":"2026-09-21","nctId":null,"outcome":null,"confidence":null,"summary":"The FDA’s decision on Merck &’s WINREVAIR (sotatercept-csrk) for Pulmonary arterial hypertension (recently diagnosed patients; label update) was due on Sep 21, 2026. The outcome isn’t recorded here yet — the linked source has the latest.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.merck.com/wp-content/uploads/sites/124/2026/02/4Q25-Merck-Earnings-Announcement.pdf","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"33ba7bc5bfa72a4f","type":"readout","title":"Sac-TMT TroFuse-005 endometrial cancer detailed Ph3 data presentation","drug":"sacituzumab tirumotecan (MK-2870)","indication":"Advanced/recurrent endometrial cancer (TroFuse-005)","phase":"Phase 3","date":"2026-09-30","datePrecision":"half","dateStart":"2026-07-01","dateEnd":"2026-12-31","nctId":null,"outcome":null,"confidence":"medium","summary":"Merck & 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.merck.com/wp-content/uploads/sites/124/2026/08/2Q26-Merck-Earnings-Presentation.pdf","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"9552f2fb5da4c300","type":"pdufa","title":"PDUFA WELIREG + LENVIMA LITESPARK-011 previously treated advanced ccRCC","drug":"WELIREG (belzutifan) + LENVIMA (lenvatinib)","indication":"Advanced clear cell RCC after PD-1/PD-L1 therapy (LITESPARK-011)","phase":"sNDA (Priority Review)","date":"2026-10-04","datePrecision":"day","dateStart":"2026-10-04","dateEnd":"2026-10-04","nctId":null,"outcome":null,"confidence":"high","summary":"The FDA’s decision on Merck &’s WELIREG (belzutifan) + LENVIMA (lenvatinib) for Advanced clear cell RCC after PD-1/PD-L1 therapy (LITESPARK-011) was due on Oct 4, 2026. The outcome isn’t recorded here yet — the linked source has the latest.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.eisai.com/news/2026/news202611.html","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"a472c4b830cacab2","type":"pdufa","title":"PDUFA for ifinatamab deruxtecan in previously treated ES-SCLC","drug":"Ifinatamab deruxtecan (I-DXd, DS-7300; Daiichi Sankyo/Merck)","indication":"Extensive-stage small cell lung cancer after platinum-based chemotherapy","phase":"BLA under Priority Review","date":"2026-10-10","datePrecision":"day","dateStart":"2026-10-10","dateEnd":"2026-10-10","nctId":null,"outcome":null,"confidence":null,"summary":"The FDA’s decision on Merck &’s Ifinatamab deruxtecan (I-DXd, DS-7300; Daiichi Sankyo/Merck) for Extensive-stage small cell lung cancer after platinum-based chemotherapy was due on Oct 10, 2026. The outcome isn’t recorded here yet — the linked source has the latest.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.merck.com/news/ifinatamab-deruxtecan-granted-priority-review-in-the-u-s-for-adult-patients-with-previously-treated-extensive-stage-small-cell-lung-cancer-who-experienced-disease-progression-on-or-after-platinum-bas/","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"a8aab1c0b859bc97","type":"conference","title":"Merck Oncology Investor Event at ESMO 2026 (Madrid)","drug":"Oncology portfolio (KEYTRUDA, sac-TMT, I-DXd, etc.)","indication":"Oncology","phase":"Various","date":"2026-10-26","datePrecision":"day","dateStart":"2026-10-26","dateEnd":"2026-10-26","nctId":null,"outcome":null,"confidence":"high","summary":"Merck & presented data on Oncology portfolio (KEYTRUDA, sac-TMT, I-DXd, etc.) for Oncology at a medical meeting on Oct 26, 2026. The linked source has the details.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.merck.com/news/merck-highlights-key-regulatory-and-clinical-milestones-across-broad-diverse-pipeline/","sourceClass":"company_or_other","verified":true,"verifiedAt":null}],"catalystsTotal":14,"catalystsTruncated":false,"catalystsPage":{"limit":100,"offset":0,"total":14,"nextOffset":null},"clinicalTrials":{"records":null,"reason":"not_redistributed","snapshot":{"status":"not_synced","fetchedAt":null,"ok":null,"storedStudyCount":null},"linkedNctIds":[]}},{"ticker":"SMMT","name":"Summit Therapeutics Inc.","categories":["oncology"],"inCuratedUniverse":true,"sec":{"cik":null,"conformedName":null,"filingsUrl":null},"catalysts":[{"id":"4c9efe59d242a1c9","type":"readout","title":"HARMONi-2: ivonescimab beat pembrolizumab in PD-L1+ NSCLC","drug":"ivonescimab","indication":"NSCLC","phase":"Phase 3","date":"2024-09-08","datePrecision":"day","dateStart":"2024-09-08","dateEnd":"2024-09-08","nctId":null,"outcome":null,"confidence":null,"summary":"Summit reported results from its Phase 3 study of ivonescimab for NSCLC on Sep 8, 2024. The linked source has what the numbers showed.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":null,"sourceClass":null,"verified":true,"verifiedAt":null},{"id":"5e6bc4bafcdfac52","type":"readout","title":"HARMONi-3 squamous interim PFS misses bar; iDMC recommends study continue","drug":"ivonescimab (SMT112)","indication":"1L metastatic squamous NSCLC","phase":"Phase 3","date":"2026-04-30","datePrecision":"day","dateStart":"2026-04-30","dateEnd":"2026-04-30","nctId":null,"outcome":"negative","confidence":"high","summary":"Summit reported results from its Phase 3 study of ivonescimab (SMT112) for 1L metastatic squamous NSCLC on Apr 30, 2026. The study missed its main goal.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://s206.q4cdn.com/652410165/files/doc_news/Summit-Therapeutics-Reports-Financial-Results-and-Operational-Progress-for-the-First-Quarter-Ended-March-31-2026-2026.pdf","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"1184c489cf27dd18","type":"readout","title":"Phase 3 HARMONi-6 met OS endpoint vs tislelizumab in 1L squamous NSCLC","drug":"ivonescimab (SMT112)","indication":"1L advanced squamous NSCLC","phase":"Phase 3","date":"2026-05-31","datePrecision":"day","dateStart":"2026-05-31","dateEnd":"2026-05-31","nctId":null,"outcome":"positive","confidence":"high","summary":"Summit reported results from its Phase 3 study of ivonescimab (SMT112) for 1L advanced squamous NSCLC on May 31, 2026. The study met its main goal.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://smmttx.com/news/press-releases/news-details/2026/Ivonescimab-with-Chemotherapy-Demonstrated-a-Statistically-Significant-Overall-Survival-Benefit-Compared-to-Tislelizumab-Plus-Chemotherapy-in-1L-Treatment-of-Patients-with-Squamous-NSCLC-in-the-HARMONi-6-Study-Conducted-by-Akeso-in-China/default.aspx","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"80217841189d7da4","type":"approval","title":"China NMPA approves ivonescimab + chemo for 1L squamous NSCLC","drug":"ivonescimab (SMT112)","indication":"1L advanced squamous NSCLC (China)","phase":"Approved","date":"2026-08-12","datePrecision":"day","dateStart":"2026-08-12","dateEnd":"2026-08-12","nctId":null,"outcome":"approved","confidence":"high","summary":"Chinese regulators approved Summit’s ivonescimab (SMT112) for 1L advanced squamous NSCLC (China) on Aug 12, 2026. The company can now sell it in that market.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/ivonescimab-in-combination-with-chemotherapy-approved-in-china-by-nmpa-for-first-line-treatment-of-patients-with-squamous-non-small-cell-lung-cancer","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"ace33b9dce56b675","type":"other","title":"First patient dosed: ivonescimab + GSK B7-H3 ADC combination study","drug":"ivonescimab + GSK B7-H3 ADC","indication":"solid tumors","phase":"early clinical","date":"2026-08-15","datePrecision":"quarter","dateStart":"2026-07-01","dateEnd":"2026-09-30","nctId":null,"outcome":null,"confidence":"high","summary":"First patient dosed: ivonescimab + GSK B7-H3 ADC combination study, in Q3 2026 (Jul–Sep). A company milestone for Summit (ivonescimab + GSK B7-H3 ADC for solid tumors): a step in the program rather than a decision or a data readout.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/summit-therapeutics-reports-financial-results-and-operational-progress-for-the-second-quarter-and-six-months-ended-june-30-2026","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"770134df1ce8f175","type":"readout","title":"HARMONi-3 squamous cohort final PFS analysis","drug":"Ivonescimab","indication":"First-line metastatic squamous NSCLC","phase":"Phase 3 (HARMONi-3)","date":"2026-09-30","datePrecision":"half","dateStart":"2026-07-01","dateEnd":"2026-12-31","nctId":null,"outcome":"mixed","confidence":null,"summary":"Summit 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/summit-therapeutics-reports-financial-results-and-operational-progress-for-the-second-quarter-and-six-months-ended-june-30-2026","sourceClass":"secondary","verified":true,"verifiedAt":null},{"id":"0385d38fb98099b2","type":"pdufa","title":"PDUFA date for ivonescimab in EGFR-mutated NSCLC post-TKI","drug":"Ivonescimab","indication":"EGFR-mutated locally advanced/metastatic non-squamous NSCLC after 3rd-gen EGFR TKI (with chemotherapy)","phase":"BLA under review","date":"2026-11-14","datePrecision":"day","dateStart":"2026-11-14","dateEnd":"2026-11-14","nctId":null,"outcome":null,"confidence":null,"summary":"The 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://smmttx.com/news/press-releases/news-details/2026/Summit-Therapeutics-Announces-U-S--FDA-Acceptance-of-Biologics-License-Application-BLA-Seeking-Approval-for-Ivonescimab-in-Combination-with-Chemotherapy-in-Treatment-of-Patients-with-EGFRm-NSCLC-Post-TKI-Therapy/default.aspx","sourceClass":"company_or_other","verified":true,"verifiedAt":null},{"id":"25803ac181671b48","type":"readout","title":"HARMONi-3 non-squamous cohort PFS analysis","drug":"Ivonescimab","indication":"First-line metastatic non-squamous NSCLC","phase":"Phase 3 (HARMONi-3)","date":"2027-03-30","datePrecision":"half","dateStart":"2027-01-01","dateEnd":"2027-06-30","nctId":null,"outcome":null,"confidence":null,"summary":"Summit 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.","summaryBy":"template","summaryAt":null,"source":"curated","sourceUrl":"https://www.biospace.com/press-releases/summit-therapeutics-reports-financial-results-and-operational-progress-for-the-second-quarter-and-six-months-ended-june-30-2026","sourceClass":"secondary","verified":true,"verifiedAt":null}],"catalystsTotal":8,"catalystsTruncated":false,"catalystsPage":{"limit":100,"offset":0,"total":8,"nextOffset":null},"clinicalTrials":{"records":null,"reason":"not_redistributed","snapshot":{"status":"not_synced","fetchedAt":null,"ok":null,"storedStudyCount":null},"linkedNctIds":[]}}],"freshness":{"responseGeneratedAt":"2026-10-29T20:53:28.626Z","sourceProcessedAt":null,"jobsEnabled":false,"hostedResearchSchedule":"off","database":"sqlite","tickerMapFetchedAt":null,"fdaCalendarFetchedAt":null},"coverage":{"categories":["ai-drug-discovery","antisense","cardiology","cell-therapy","gene-editing","gene-therapy","immunology","large-biotech","large-pharma","liver","mrna","neuro","obesity","oncology","platform","protein-degradation","pulmonology","rare-disease","rnai","vaccines","virology"],"rateLimit":{"perMinute":120,"burst":40,"scope":"single_process_memory"},"cache":{"success":"public, s-maxage=300, stale-while-revalidate=900","errors":"no-store"},"secTickerMap":{"fetchedAt":null,"ok":null},"fdaAdvisoryCalendar":{"redistributed":false,"fetchedAt":null,"ok":null}},"fdaAdvisoryMeetings":null,"nulls":{"sec.cik":"No CIK is stored for this company. The preview does not look one up during the request.","sec.conformedName":"Absent unless company_tickers.json has been synced into this database.","sec.filingsUrl":"Absent when cik is absent. The URL is an EDGAR search link, not a filing.","catalyst.confidence":"Null when the curated seed left confidence unset. The database loader stores high in that case; this API does not repeat that default.","catalyst.summary":"Null when no eligible admin or research note is stored and the field template cannot be built. The template is our two-sentence explanation of the published catalog fields. It is not a source body. A stored note over 400 characters, or one that contains a URL, is not eligible.","catalyst.summaryAt":"Null when summary is null, when summaryBy is template, when the sentence matches the seed file, or when no separate write time is stored. A template has no timestamp: response generation is not a source or editorial date. The seed loader stamps summary_at at startup, and the seed file has no authorship time, so that clock is not published. A research note or a later edit whose text is not the seed sentence keeps its stored time.","catalyst.summaryBy":"Null when summary is null. Otherwise admin, research, or template. template means this response generated the sentence from published fields.","catalyst.verifiedAt":"Null when no verification pass recorded a time. verified true on a curated row means the row was accepted into the seed, not that someone re-checked it on a known date.","catalyst.sourceUrl":"Null when the row has no http(s) link, or the only link is a Google News wrapper.","catalyst.sourceClass":"Null when sourceUrl is null. company_or_other is not a finding that the host is the company’s official site.","catalyst.nctId":"Null when the curated row does not name a ClinicalTrials.gov study.","catalyst.outcome":"Null when the row has no short outcome label, or the stored text is not one of the known labels.","catalyst.drug":"Null when the curated row does not name a drug.","catalyst.indication":"Null when the curated row does not name an indication.","catalyst.phase":"Null when the curated row does not name a phase.","catalyst.dateStart":"Null only when the row has no window start.","catalyst.dateEnd":"Null only when the row has no window end.","clinicalTrials.records":"Always null. Study records are not redistributed in this preview.","clinicalTrials.snapshot.fetchedAt":"Null when this database has no trials sync row for the company.","clinicalTrials.snapshot.storedStudyCount":"Null when studies were never synced here. A number is a row count, not a claim that the set is current.","clinicalTrials.linkedNctIds":"NCT ids on the catalysts in this page only. An empty array means this page has none. Other pages are not included.","fdaAdvisoryMeetings":"Always null. Advisory meetings are not matched to a company, and their titles are not copied.","freshness.sourceProcessedAt":"Always null. The seed has no single source-processing timestamp, and this response does not invent one."},"notices":["Public developer preview. No API key, no account, no paid plan, and no uptime or freshness guarantee.","The Vercel deployment serves the reviewed seed from disposable SQLite. It does not run the research schedule. Its cron checks the activity cache only.","jobsEnabled describes this process. True means a long-lived server may start jobs. It does not mean a research run succeeded or that sources are current.","ClinicalTrials.gov study text is not included. Posted terms expect current data and the date ClinicalTrials.gov processed it. This preview keeps neither.","FDA advisory-meeting titles are not included. The calendar feed does not name a sponsor in a way this app trusts.","SEC CIK is included only when this database already stores one, on the ticker map or the company row. The EDGAR conformed name comes only from the ticker map. Filing documents are not included.","summary is a stored admin or research note when one is eligible: at most 400 characters and no URL. Otherwise it is a template sentence from the published title, drug, indication, phase, date, precision, outcome, ticker, and company name. The template limit is 1600 characters and a longer sentence is omitted whole, not cut. summaryAt is null for a template. It is also null when a stored sentence matches the seed, because the loader clock is startup, not authorship. A missing confidence is null, not high.","sourceUrl points at a page. It is not permission to copy that page. Wire and secondary hosts are labeled.","Omitted on purpose: prices, market cap, returns, index weights, price reactions, congressional and other trade records, news headlines, and press-release or article bodies.","The rate limit is an in-memory bucket on one server process. Serverless isolates do not share it, so it is not a global quota."]}