Frexalimab Phase 3 data in relapsing multiple sclerosis (FREXALT)
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.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Sanofi SNY
- 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; the calendar never invents one
- 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.
- Checked
- Checked by a person when it was added
- Source: sanofi.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- SNY headlines on this site
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.
More details
- Entry
- 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).
- Checked
- Checked by a person when it was added
- Verify it
- Source: sanofi.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- SNY headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
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.
More details
- 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.
- Checked
- Checked by a person when it was added
- Verify it
- Source: sanofi.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- SNY headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
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.
More details
- 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.
- Checked
- Checked by a person when it was added
- Verify it
- Source: sanofi.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- SNY headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
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.
More details
- 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.
- Checked
- Checked by a person when it was added
- Verify it
- Source: sanofi.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- SNY headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
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.
More details
- Entry
- 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.
- Checked
- Checked by a person when it was added
- Verify it
- Source: sanofi.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- SNY headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
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.
More details
- 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).
- Checked
- Checked by a person when it was added
- Verify it
- Source: sanofi.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- SNY headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page