FDA decisionNov 2026a window, not a day

PDUFA target action date for cemdisiran in generalized myasthenia gravis

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.

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary

DetailsFDA decision due · also called: PDUFA date

Company: Regeneron Pharmaceuticals, Inc. REGN
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; the calendar never invents one
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

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
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