Upcoming catalysts
Trial resultsSNYSanofiH2 2026 Sanofi 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.
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- Sarclisa Phase 3 data in transplant-eligible multiple myeloma · Clinical trial results (readout / topline data)
- Drug
- Sarclisa (isatuximab)
- For
- Transplant-eligible newly diagnosed multiple myeloma
- 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
- Listed in the 'anticipated major upcoming pipeline milestones — H2 2026' table of Sanofi's Q2 2026 results press release (July 30, 2026).
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MilestoneSNYSanofiH2 2026 Efdoralprin 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.
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- Entry
- Efdoralprin alfa US regulatory submission in alpha-1 antitrypsin deficiency · Company milestone
- Drug
- Efdoralprin alfa
- For
- Alpha-1 antitrypsin deficiency emphysema
- Stage
- Registrational · a study designed to support approval
- When
- H2 2026 · the company gave a window, not a day
- Source note
- US regulatory submission listed under H2 2026 milestones in Sanofi's Q2 2026 results press release.
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FDA decisionSNYSanofiH2 2026 The 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.
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- Entry
- FDA decision on Fluzone High-Dose/Efluelda for adults 50+ · FDA decision due (PDUFA date)
- Drug
- Fluzone HD / Efluelda
- For
- Influenza, adults aged 50+
- Stage
- sBLA under review
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 press release 'Anticipated major upcoming pipeline milestones' table (Jul 30, 2026); EU decision guided for 2027.
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Sanofi 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.
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- Entry
- Japan decision on Dupixent in pediatric chronic spontaneous urticaria · Regulatory approval
- Drug
- Dupixent (dupilumab)
- For
- Chronic spontaneous urticaria (children); allergic fungal rhinosinusitis
- Stage
- Under MHLW review
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 milestones table.
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MilestoneSNYSanofiH2 2026 Nexviazyme 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.
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- Nexviazyme US label-extension submission for infantile-onset Pompe disease · Company milestone
- Drug
- Nexviazyme (avalglucosidase alfa)
- For
- Infantile-onset Pompe disease
- 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
- Sanofi Q2 2026 press release; Baby-COMET met primary and all secondary endpoints.
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MilestoneSNYSanofiH2 2026 SP0087 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.
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- Entry
- SP0087 rabies vaccine EU decision and US submission · Company milestone
- Drug
- SP0087
- For
- Rabies
- Stage
- Regulatory
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 milestones table (row layout slightly ambiguous in PDF extraction).
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FDA decisionSNYSanofiNov 25, 2026 The 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.
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- Entry
- PDUFA for venglustat in type 3 Gaucher disease · FDA decision due (PDUFA date)
- Drug
- Venglustat (glucosylceramide synthase inhibitor)
- For
- Type 3 Gaucher disease (GD3)
- Stage
- NDA under Priority Review
- When
- Nov 25, 2026
- Source note
- 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.
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Trial resultsSNYSanofi2027 Sanofi 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.
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- Entry
- Frexalimab Phase 3 data in relapsing multiple sclerosis (FREXALT) · Clinical trial results (readout / topline data)
- Drug
- Frexalimab (anti-CD40L)
- For
- Relapsing multiple sclerosis
- Stage
- 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.
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Sanofi 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.
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- Entry
- EU and Japan decisions on venglustat for type 3 Gaucher disease · Regulatory approval
- Drug
- Venglustat
- For
- Gaucher disease type 3
- Stage
- Under review (EU, JP)
- When
- 2027 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 milestones table; US PDUFA (Nov 25, 2026) already tracked.
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Trial resultsSNYSanofi2027 Sanofi 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.
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- Entry
- Phase 2 readouts: brivekimig in HS and lunsekimig in high-risk asthma · Clinical trial results (readout / topline data)
- Drug
- Brivekimig; lunsekimig
- For
- Hidradenitis suppurativa; asthma (high risk)
- Stage
- Phase 2 · the stage that tests whether the drug actually works
- When
- 2027 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 milestones table.
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Trial resultsSNYSanofi2027 Sanofi 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.
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- Entry
- Fitusiran Phase 3 data in hemophilia A/B (12+ years) and EU/JP submissions · Clinical trial results (readout / topline data)
- Drug
- Qfitlia (fitusiran)
- For
- Hemophilia A/B
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- 2027 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 milestones table.
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Trial resultsSNYSanofi2027 Sanofi 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.
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- Entry
- Riliprubart Phase 3 data in CIDP and US/EU submissions · Clinical trial results (readout / topline data)
- Drug
- Riliprubart
- For
- Chronic inflammatory demyelinating polyneuropathy
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- 2027 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 milestones table.
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Sarclisa 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.
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- Entry
- Sarclisa transplant-eligible NDMM US submission; Sarclisa SC China decision · Company milestone
- Drug
- Sarclisa (isatuximab)
- For
- Transplant-eligible newly diagnosed multiple myeloma; SC formulation
- Stage
- Regulatory
- When
- 2027 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 milestones table; TE-NDMM Phase 3 data guided H2 2026 (already tracked).
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Myqorzo (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.
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- Entry
- Myqorzo (nHCM) and Redemplo (sHTG) China submissions · Company milestone
- Drug
- Myqorzo; Redemplo
- For
- Non-obstructive HCM; severe hypertriglyceridemia
- Stage
- Regulatory
- When
- 2027 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 press release; milestones table lists Myqorzo nHCM and Redemplo sHTG China submissions in 2027.
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Trial resultsSNYSanofi2027 Sanofi 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.
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- Entry
- SP0202 pneumococcal and SP0218 yellow fever vaccine Phase 3 data · Clinical trial results (readout / topline data)
- Drug
- SP0202; SP0218
- For
- Pneumococcal disease; yellow fever
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- 2027 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 milestones table; SP0202 US/EU submissions guided 2028.
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Trial resultsSNYSanofi2028 Sanofi expects to report results from its Phase 3 study of Wayrilz (rilzabrutinib) for IgG4-related disease; warm autoimmune hemolytic anemia during 2028 (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.
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- Entry
- Wayrilz Phase 3 data in IgG4-RD and wAIHA with US/EU submissions · Clinical trial results (readout / topline data)
- Drug
- Wayrilz (rilzabrutinib)
- For
- IgG4-related disease; warm autoimmune hemolytic anemia
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- 2028 · the company gave a window, not a day
- Source note
- Sanofi Q2 2026 milestones table.
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Past catalysts
MilestoneSNYSanofiJul 24, 2026 Sanofi discontinues amlitelimab in atopic dermatitis, will not file globally, on Jul 24, 2026. A company milestone for Sanofi (Amlitelimab (SAR445229) for Moderate-to-severe atopic dermatitis): a step in the program rather than a decision or a data readout.
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- Entry
- Sanofi discontinues amlitelimab in atopic dermatitis, will not file globally · Company milestone
- Drug
- Amlitelimab (SAR445229)
- For
- Moderate-to-severe atopic dermatitis
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Jul 24, 2026
- Source note
- Despite positive Phase 3 data presented at AAD in March, Sanofi said it will not submit amlitelimab in moderate-to-severe atopic dermatitis and is discontinuing development in that indication.
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ApprovalSNYSanofiJul 10, 2026 The FDA approved Sanofi’s Sarclisa (isatuximab-irfc) Escena for Multiple myeloma on Jul 10, 2026. The company can now sell it in that market.
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- Entry
- FDA approves subcutaneous Sarclisa Escena, first anticancer drug via on-body injector · Regulatory approval
- Drug
- Sarclisa (isatuximab-irfc) Escena
- For
- Multiple myeloma
- Stage
- Approved / registrational · a study designed to support approval
- When
- Jul 10, 2026
- Source note
- Sanofi announced US approval of SC Sarclisa Escena across all existing IV Sarclisa myeloma indications, resolving the review whose action date had been pushed to July 23, 2026.
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Trial resultsSNYSanofiJun 30, 2026 Sanofi reported results from its Phase 3 study of Nexviazyme (avalglucosidase alfa) for Infantile-onset Pompe disease on Jun 30, 2026. The study met its main goal.
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- Entry
- Nexviazyme met all primary and secondary endpoints in infantile-onset Pompe Phase 3 · Clinical trial results (readout / topline data)
- Drug
- Nexviazyme (avalglucosidase alfa)
- For
- Infantile-onset Pompe disease
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Jun 30, 2026
- Source note
- The single-arm Baby-COMET study hit its primary endpoint of ventilator-free survival at 52 weeks in treatment-naive infants six months and younger with infantile-onset Pompe disease.
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ApprovalSNYSanofiJun 13, 2026 The FDA approved Sanofi’s Tzield (teplizumab-mzwv) for Newly diagnosed stage 3 type 1 diabetes, ages 8-17 on Jun 13, 2026. The company can now sell it in that market.
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- Entry
- FDA grants Tzield accelerated approval in newly diagnosed stage 3 type 1 diabetes · Regulatory approval
- Drug
- Tzield (teplizumab-mzwv)
- For
- Newly diagnosed stage 3 type 1 diabetes, ages 8-17
- Stage
- Approved / registrational · a study designed to support approval
- When
- Jun 13, 2026
- Source note
- Sanofi said the FDA granted accelerated approval for Tzield to delay decline in endogenous insulin production in children aged 8-17 recently diagnosed with stage 3 T1D, a first disease-modifying use.
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Trial resultsSNYSanofiJun 10, 2026 Sanofi reported results from its Phase 3 study of Riliprubart (SAR445088) for Chronic inflammatory demyelinating polyneuropathy, refractory on Jun 10, 2026. The study missed its main goal.
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- Riliprubart MOBILIZE Phase 3 in CIDP stopped for futility at interim analysis · Clinical trial results (readout / topline data)
- Drug
- Riliprubart (SAR445088)
- For
- Chronic inflammatory demyelinating polyneuropathy, refractory
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Jun 10, 2026
- Source note
- An independent data monitoring committee found MOBILIZE unlikely to show sufficient efficacy in standard-of-care-refractory CIDP, and Sanofi stopped the study; no riliprubart safety signals were identified.
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FDA decisionSNYSanofiApr 22, 2026 The FDA’s decision on Sanofi’s Sarclisa (isatuximab-irfc) subcutaneous for Multiple myeloma was due on Apr 22, 2026. The outcome isn’t recorded here yet — the linked source has the latest.
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- Entry
- FDA extends Sarclisa subcutaneous US action date by three months to July 23, 2026 · FDA decision due (PDUFA date)
- Drug
- Sarclisa (isatuximab-irfc) subcutaneous
- For
- Multiple myeloma
- Stage
- Registrational · a study designed to support approval
- When
- Apr 22, 2026
- Source note
- Sanofi said the FDA extended by up to three months the target action date for the subcutaneous Sarclisa BLA across all approved multiple myeloma indications, pushing the decision to July 23, 2026.
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ApprovalSNYSanofiApr 22, 2026 The FDA approved Sanofi’s Tzield (teplizumab-mzwv) for Stage 2 type 1 diabetes, patients aged 1+ on Apr 22, 2026. The company can now sell it in that market.
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- Entry
- FDA expands Tzield to children as young as one to delay stage 3 type 1 diabetes · Regulatory approval
- Drug
- Tzield (teplizumab-mzwv)
- For
- Stage 2 type 1 diabetes, patients aged 1+
- Stage
- Approved / registrational · a study designed to support approval
- When
- Apr 22, 2026
- Source note
- Sanofi announced FDA approval of a supplemental BLA extending Tzield's indication from age eight down to age one for delaying onset of stage 3 T1D in patients with stage 2 disease.
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ConferenceSNYSanofiMar 28, 2026 Sanofi presented data on Amlitelimab (SAR445229) for Moderate-to-severe atopic dermatitis at a medical meeting on Mar 28, 2026. The linked source has the details.
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- Entry
- Positive amlitelimab Phase 3 atopic dermatitis data presented at AAD 2026 late-breaker · Data presented at a medical meeting
- Drug
- Amlitelimab (SAR445229)
- For
- Moderate-to-severe atopic dermatitis
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Mar 28, 2026
- Source note
- Sanofi presented results from three Phase 3 amlitelimab studies in moderate-to-severe atopic dermatitis in the AAD late-breaking research session, showing improved skin clearance versus placebo.
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