Sanofi SNY
Sanofi (Nasdaq: SNY) is an immunology/inflammation drug developer. Its lead program, Dupixent (dupilumab; marketed portfolio), is in Phase 3 for Atopic dermatitis and other type 2 inflammatory diseases. Its next catalyst on record is venglustat: FDA target action date for venglustat NDA in Gaucher disease type 3 (priority review) (November 25, 2026).
Upcoming catalysts
- November 25, 2026venglustat — FDA target action date for venglustat NDA in Gaucher disease type 3 (priority review)
The target action date for the FDA decision is November 25, 2026.
Next further out: Dupixent — Dupixent regulatory decision for CSU in children expected in Japan in Q4 2026. (Q4 2026). 9 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Dupixent (dupilumab) | Atopic dermatitis, asthma, COPD, CSU, bullous pemphigoid, others | antibody | Approved |
| Qfitlia (fitusiran) | Hemophilia A or B | RNA (siRNA/ASO/mRNA) | Approved |
| Wayrilz (rilzabrutinib) | Immune thrombocytopenia | small molecule | Approved |
| tolebrutinib | Secondary progressive multiple sclerosis | small molecule | Phase 3 |
| amlitelimab | Atopic dermatitis | antibody | Phase 3 |
| duvakitug | Ulcerative colitis; Crohn's disease | antibody | Phase 3 |
| itepekimab | COPD; chronic rhinosinusitis with nasal polyps | antibody | Phase 3 |
| lunsekimig | COPD (Phase 3); asthma (Phase 2) | antibody | Phase 3 |
| frexalimab | Relapsing MS; non-relapsing secondary progressive MS | antibody | Phase 3 |
| riliprubart | CIDP | antibody | Phase 3 |
| venglustat | Fabry disease; Gaucher disease type 3 | small molecule | Phase 3 |
| elenestinib | Indolent/smoldering systemic mastocytosis | small molecule | Phase 3 |
Recent results and decisions
- Oct 30, 2026approval US FDA approved a label update for Ayvakit including a 50 mg daily dose option in adults with indolent systemic mastocytosis.
The US FDA approved a label update for Ayvakit including a 50 mg daily dose option in adults with indolent systemic mastocytosis (ISM), for use as clinically indicated after at least six months of treatment at 25 mg daily.
Filing - Oct 30, 2026approval EU approved an extension of the indication for MenQuadfi to include infants from six weeks of age.
The EU approved an extension of the indication for MenQuadfi (Meningococcal Group A, C, W and Y conjugate vaccine) to include infants from six weeks of age to help protect against invasive meningococcal disease.
Filing - Oct 30, 2026accepted The European Medicines Agency accepted Teizeild for regulatory review to delay the onset of stage 3 type 1 diabetes in patients aged one to seven years.
The European Medicines Agency (EMA) accepted Teizeild for regulatory review to delay the onset of stage 3 type 1 diabetes (T1D) in patients aged one to seven years diagnosed with stage 2 T1D.
Filing
53 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 immunology/inflammation companies
- Argenx SE ARGX
- Roivant Sciences Ltd. ROIV
- Immunovant, Inc. IMVT
- Celldex Therapeutics, Inc. CLDX
- Biohaven Ltd. BHVN
- BioCryst Pharmaceuticals, Inc. BCRX
- Zenas BioPharma ZBIO
- Nektar Therapeutics NKTR
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.