ApprovalH2 2027a window, not a day
European Commission decision on cemdisiran in gMG
Regeneron expects European regulators to decide on cemdisiran (C5 siRNA) for Generalized myasthenia gravis in the second half of 2027 (no exact date yet). An approval lets the company start selling it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
DetailsRegulatory approval
- Company
- Regeneron Pharmaceuticals, Inc. REGN
- Drug
- cemdisiran (C5 siRNA)
- For
- Generalized myasthenia gravis
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2027 · the company gave a window, not a day; the calendar never invents one
- Source note
- EMA accepted the MAA; Regeneron says a European Commission decision is anticipated in the second half of 2027. Japan filing planned for early 2027.
- Checked
- Checked by a person when it was added
Check the sourcesdon’t take our word for it
- Source: investor.regeneron.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
- REGN headlines on this site
Regeneron Pharmaceuticals, Inc.
2 upcoming · 5 past catalysts
More from REGN
The FDA is expected to decide in Nov 2026 (no exact date yet) whether to approve Regeneron’s cemdisiran (C5 siRNA) for Generalized myasthenia gravis (anti-AChR antibody-positive). 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
- PDUFA target action date for cemdisiran in generalized myasthenia gravis · FDA decision due (PDUFA date)
- Drug
- cemdisiran (C5 siRNA)
- For
- Generalized myasthenia gravis (anti-AChR antibody-positive)
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Nov 2026 · the company gave a window, not a day
- Source note
- FDA accepted the NDA under Priority Review (priority review voucher used) with a target action date in November 2026; announced June 22, 2026. Would be the first siRNA approved in gMG, dosed subcutaneously every 12 weeks.
- Checked
- Checked by a person when it was added
- Verify it
- Source: investor.regeneron.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
- REGN headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page