FDA accepts cemdisiran NDA under Priority Review in gMG; PDUFA Nov 2026
FDA accepts cemdisiran NDA under Priority Review in gMG; PDUFA Nov 2026, on Jun 22, 2026. A company milestone for Regeneron (Cemdisiran for Generalized myasthenia gravis (anti-AChR antibody positive)): a step in the program rather than a decision or a data readout.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Regeneron Pharmaceuticals, Inc. REGN
- Drug
- Cemdisiran
- For
- Generalized myasthenia gravis (anti-AChR antibody positive)
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Jun 22, 2026
- Source note
- FDA accepted the cemdisiran NDA under Priority Review with a November 2026 target action date, and EMA accepted the EU application, both supported by the Phase 3 NIMBLE trial in anti-AChR antibody-positive generalized myasthenia gravis.
- Checked
- Checked by a person when it was added
- Source: biospace.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
- REGN headlines on this site
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