Sanofi SA (SNY) — Upcoming Catalysts
FDA PDUFA dates, advisory-committee meetings, and Phase 2/3 readout windows for Sanofi SA, built from public data lanes (ClinicalTrials.gov and official sources). Each row links to its source.
For informational purposes only — not investment advice. Track SNY live on Mooboard →
This week2
- Sep 29, 2026ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutAmlitelimab · Phase 2 · AsthmaNCT06033833: Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study. Primary completion 2026-09-29 (estimated); status ACTIVE_NOT_RECRUITING.
- Sep 30, 2026ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutbalinatunfib · Phase 2 · Colitis Ulcerative; Crohn's DiseaseNCT07222189: A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Disease or Ulcerative Colitis (SPECIFI-IBD-LTS). Primary completion 2026-09-30 (estimated); status ACTIVE_NOT_RECRUITING.
Next 30 days1
- Oct 14, 2026ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutItepekimab (SAR440340) · Phase 3 · Chronic Rhinosinusitis With Nasal PolypsNCT06834347: A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps. Primary completion 2026-10-14 (estimated); status ACTIVE_NOT_RECRUITING.
31–90 days9
- Oct 30, 2026ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutvenglustat (GZ402671) · Phase 2 · Gaucher Disease Type 1; Gaucher Disease Type 3NCT02843035: Venglustat in Combination With Cerezyme in Adult Patients With Gaucher Disease Type 3 With Venglustat Monotherapy Extension. Primary completion 2026-10-30 (estimated); status ACTIVE_NOT_RECRUITING.
- Nov 5, 2026ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutFitusiran · Phase 3 · HemophiliaNCT03754790: Long-term Safety and Efficacy Study of Fitusiran in Patients With Hemophilia A or B, With or Without Inhibitory Antibodies to Factor VIII or IX. Primary completion 2026-11-05 (estimated); status ACTIVE_NOT_RECRUITING.
- Nov 6, 2026ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutItepekimab (SAR440340) · Phase 3 · Chronic Rhinosinusitis With Nasal PolypsNCT06834360: A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps. Primary completion 2026-11-06 (estimated); status ACTIVE_NOT_RECRUITING.
- Nov 30, 2026ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutrilzabrutinib · Phase 3 · Immune ThrombocytopeniaNCT07216079: Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan. Primary completion 2026-11-30 (estimated); status ACTIVE_NOT_RECRUITING.
- Dec 1, 2026ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutPCV21 · Phase 3 · Pneumococcal InfectionsNCT06838000: Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and Adolescents. Primary completion 2026-12-01 (estimated); status ACTIVE_NOT_RECRUITING.
- Dec 1, 2026ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutPandemic flu H5 HA mRNA SD2 vaccine · Phase 1 / Phase 2 · Pandemic Influenza Immunization; Healthy VolunteersNCT06907511: Study to Evaluate the Safety and the Immunogenicity of a Second Generation Structurally Designed mRNA Vaccine Candidate Against Pandemic Influenza H5 HA Strain in Healthy Adult Participants Aged 18 Years and Older. Primary completion 2026-12-01 (estimated); status ACTIVE_NOT_RECRUITING.
- Dec 17, 2026ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutSAR442970 · Phase 2 · Crohn's DiseaseNCT06958536: A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease. Primary completion 2026-12-17 (estimated); status RECRUITING.
- Dec 17, 2026ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutSAR442970 · Phase 2 · Ulcerative ColitisNCT06975722: A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis. Primary completion 2026-12-17 (estimated); status RECRUITING.
- Dec 23, 2026ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutfrexalimab · Phase 2 · Focal Segmental Glomerulosclerosis; Glomerulonephritis Minimal LesionNCT06500702: A Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease. Primary completion 2026-12-23 (estimated); status RECRUITING.
Later13
- Jan 7, 2027ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutPCV21 · Phase 3 · Sickle Cell DiseaseNCT07247188: Study of a Single Dose of a 21-valent Pneumococcal Conjugate Vaccine in Children and Adolescents With Sickle Cell Disease. Primary completion 2027-01-07 (estimated); status RECRUITING.
- Jan 8, 2027ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutIsatuximab SC-OBDS · Phase 2 · Plasma Cell Myeloma RefractoryNCT06356571: A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma. Primary completion 2027-01-08 (estimated); status RECRUITING.
- Jan 15, 2027ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutefanesoctocog alfa (BIVV001) · Phase 3 · Hemophilia ANCT04644575: Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A. Primary completion 2027-01-15 (estimated); status ACTIVE_NOT_RECRUITING.
- Jan 18, 2027ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutInvestigational hMPV/RSV vaccine · Phase 1 / Phase 2 · Human Metapneumovirus Immunization; Respiratory Syncytial Virus ImmunizationNCT06686654: Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and Older. Primary completion 2027-01-18 (estimated); status ACTIVE_NOT_RECRUITING.
- Jan 19, 2027ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutSAR445877 · Phase 1 / Phase 2 · Solid TumorNCT05584670: A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors. Primary completion 2027-01-19 (estimated); status RECRUITING.
- Feb 9, 2027ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutBrivekimig · Phase 2 · Hidradenitis SuppurativaNCT07170917: Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa. Primary completion 2027-02-09 (estimated); status RECRUITING.
- Feb 17, 2027ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutItepekimab (SAR440340) · Phase 3 · Chronic Rhinosinusitis With Nasal PolypsNCT07424144: An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps. Primary completion 2027-02-17 (estimated); status ACTIVE_NOT_RECRUITING.
- Mar 25, 2027ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutFitusiran · Phase 3 · HemophiliaNCT05662319: A Study to Test a Medicine (Fitusiran) Injected Under the Skin for Preventing Bleeding Episodes in Male Adolescent or Adult Participants With Severe Hemophilia. Primary completion 2027-03-25 (estimated); status ACTIVE_NOT_RECRUITING.
- Apr 5, 2027ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutIsatuximab SAR650984 · Phase 3 · Plasma Cell MyelomaNCT03319667: A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant. Primary completion 2027-04-05 (estimated); status ACTIVE_NOT_RECRUITING.
- Apr 8, 2027ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutSAR444336 · Phase 2 · Microscopic ColitisNCT07156175: A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission. Primary completion 2027-04-08 (estimated); status RECRUITING.
- Apr 28, 2027ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutFrexalimab · Phase 2 · Type 1 Diabetes MellitusNCT06111586: Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults, Adolescents and Children on Top of Insulin Therapy (FABULINUS). Primary completion 2027-04-28 (estimated); status ACTIVE_NOT_RECRUITING.
- Apr 29, 2027ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutBrivekimig · Phase 2 · Type 1 Diabetes MellitusNCT06812988: Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule. Primary completion 2027-04-29 (estimated); status ACTIVE_NOT_RECRUITING.
- May 6, 2027ClinicalTrials.gov ↗Sanofi SA(SNY)Phase 2/3 readoutFrexalimab · Phase 3 · Multiple SclerosisNCT06141473: Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis. Primary completion 2027-05-06 (estimated); status ACTIVE_NOT_RECRUITING.
How Sanofi SA has moved — past-year price reactions
How binary is SNY? Its typical daily move, how often it swings ±10%, and its biggest single-day moves over the last year — useful context for sizing around a catalyst.
0.9%
0
24.2%
249
Largest single-day moves
- -5.9%2026-05-04no matched headline
- +5.4%2025-10-01no matched headline
- +4.7%2026-06-04no matched headline
- -4.5%2026-02-12no matched headline
- -4.4%2026-07-30no matched headline
- +4.3%2025-10-24no matched headline
Real daily price moves over the past year — not every move is a catalyst, and headlines (where shown) are a possible same-day driver, not confirmed causation.
Sanofi SA — active clinical pipeline
Sanofi SA's registered Phase 1–3 programs by asset and indication, derived from ClinicalTrials.gov.
72 assets111 programsPh1 9Ph2 54Ph3 35· 13 post-marketing (Ph4)
AreasOncologyAutoimmuneImmunologyMetabolicNeuroscienceInfectiousOphthalmologyRare / GeneticOther
RilzabrutinibAutoimmune · BTK
AmlitelimabImmunology · OX40L
Phase 3
BelumosudilImmunology · ROCK2
FrexalimabNeuroscience
LunsekimigImmunology
PCV21Infectious
RiliprubartImmunology
avalglucosidase alfaOther · Glycogen
efanesoctocog alfa (BIVV001)Rare / Genetic · Factor VIII
Phase 3
FitusiranRare / Genetic · Antithrombin mRNA
Phase 3
Isatuximab IVOncology
Isatuximab SAR650984Oncology
Phase 3
Itepekimab (SAR440340)Immunology
MenACYW conjugate vaccineInfectious
Phase 3
Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate VaccineOther
Phase 3
MenQuadfi® (Meningococcal Polysaccharide [Serogroups A, C, W, and Y] Tetanus Toxoid Conjugate Vaccine) (Sanofi Pasteur Inc., Swiftwater, PA, USA)Infectious
Phase 3
PCV21 vaccineOther
Riliprubart Prefilled Pen (PFP)Immunology
TolebrutinibNeuroscience · BTK
Phase 3
VenglustatRare / Genetic · UGCG
Phase 3
Yellow fever vaccine (live)Other
Phase 3
BrivekimigImmunology
IsatuximabOncology · CD38
SAR441344 IVNeuroscience
SAR441566Autoimmune
SAR442970Autoimmune
SAR445877Oncology
Phase 2
Acne mRNA (messenger ribonucleic acid) vaccineOther
Phase 2
Acne mRNA vaccineOther
Phase 2
Avalglucosidase alfa (GZ402666)Rare / Genetic · Glycogen
balinatunfibAutoimmune
Phase 2
Bivalent RSV+HMPV protein vaccineInfectious
Phase 2
BIVV020 (SAR445088)Immunology
Phase 2
Blood draw for the laboratory assessmentOther
Phase 2
Chlamydia mRNA VaccineOther
Flu H5 egg pandemic low dose vaccine, with adjuvantInfectious
Phase 2
Investigational hMPV/RSV vaccineOther
Isatuximab intravenous (IV)Oncology
Phase 2
Isatuximab SC-OBDSOncology
Long term follow up in all patients who received SAR422459 in previous study TDU13583Ophthalmology
Phase 2
Pandemic flu H5 HA mRNA SD2 vaccineInfectious
Pentavalent Meningococcal ABCYW vaccineOther
Phase 2
Rilzabrutinib dose 1Autoimmune
Phase 2
RSV+HMPV vaccineInfectious
SAR402663Ophthalmology
SAR443122Autoimmune
Phase 2
SAR444336Autoimmune
Phase 2
SAR444836Other
Phase 2
SAR445399Immunology
Phase 2
SAR446268Other
Phase 2
SAR446597Ophthalmology
Phase 2
SAR447537Other
SAR448851Neuroscience
Phase 2
Sarilumab SAR153191 (REGN88)Autoimmune
Sarilumab, SAR153191 SCAutoimmune
Phase 2
Yellow fever vaccine (produced on serum-free Vero cells)Other
Phase 2
SAR448501Oncology
Dupilumab coformulated with berahyaluronidase alfaOther
Phase 1
H5 Flu Investigational Medical Product (IMP) 1Infectious
SAR446523Oncology
SAR447971Immunology
Phase 1
trivalent (RSV/hMPV/PIV3) vaccine candidateOther
VXB-241 60 mcg (Low Dose)Infectious
Phase 1
Active registered Phase 1–3 trials from ClinicalTrials.gov — not the company's official IR pipeline (no preclinical or undisclosed assets). Grouped by trial intervention name; therapeutic area is auto-categorized. Each indication links to its trial. Molecular targets sourced from ChEMBL (EMBL-EBI).
Targets from a ChEMBL (EMBL-EBI) snapshot dated 2026-08-20 · 310/1701 assets resolved when it was built
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