# Cemdisiran PDUFA Event: Generalized myasthenia gravis

Canonical URL: https://biopharmsignal.com/pdufa-calendar/REGN/cemdisiran-generalized-myasthenia-gravis

Ticker: REGN

Company: Regeneron Pharmaceuticals

Event date: 2026-11-30

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA assigned a November 2026 target action date to the cemdisiran NDA submitted under Priority Review; the company has not disclosed a...

## Event Timeline

### November 2026 — FDA decision expected

FDA assigned a November 2026 target action date to the cemdisiran NDA submitted under Priority Review; the company has not disclosed a more specific day.

[Regeneron — Cemdisiran NDA acceptance and PDUFA timing](https://newsroom.regeneron.com/news-releases/news-release-details/cemdisiran-regulatory-submissions-accepted-review-fda-and-ema/)

### June 22, 2026 — FDA accepted the NDA with Priority Review

FDA accepted the cemdisiran NDA for adults with anti-AChR antibody-positive generalized myasthenia gravis under Priority Review after use of a Priority Review Voucher.

[Regeneron — Cemdisiran NDA acceptance](https://newsroom.regeneron.com/news-releases/news-release-details/cemdisiran-regulatory-submissions-accepted-review-fda-and-ema/)

### August 26, 2025 — NIMBLE Phase 3 results were reported

Cemdisiran monotherapy met the primary and key secondary endpoints in NIMBLE. The trial also evaluated cemdisiran plus pozelimab, but the filed U.S. NDA is for cemdisiran monotherapy.

[Regeneron — Positive NIMBLE Phase 3 results](https://newsroom.regeneron.com/news-releases/news-release-details/regeneron-announces-positive-results-phase-3-trial-generalized/)

### September 14, 2021 — NIMBLE Phase 3 study started

NIMBLE began evaluating cemdisiran monotherapy and the cemdisiran-pozelimab combination in adults with symptomatic generalized myasthenia gravis.

[ClinicalTrials.gov — NIMBLE study record (NCT05070858)](https://clinicaltrials.gov/study/NCT05070858)

## Regulatory Designations

- Priority Review FDA: [Regeneron — Cemdisiran NDA acceptance and Priority Review](https://newsroom.regeneron.com/news-releases/news-release-details/cemdisiran-regulatory-submissions-accepted-review-fda-and-ema/)

## Related Pages

- REGN PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/REGN.md

- REGN company profile: https://biopharmsignal.com/company/REGN.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

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- 2026-10-01 — Phase 2 COURAGE Trial Confirms Trevogrumab Prevents Lean Mass and Muscle Loss During GLP-1 Receptor Agonist-induced Weight Loss: https://biopharmsignal.com/news/REGN/phase-2-courage-trial-confirms-trevogrumab-prevents-lean-mass-and-muscle-loss-du-6cbd2c3a.md

- 2026-10-01 — Regeneron and Sanofi Expand Global Alliance with Multiple Next-Generation, Long-Acting Immunology Antibodies: https://biopharmsignal.com/news/REGN/regeneron-and-sanofi-expand-global-alliance-with-multiple-next-generation-long-a-e5cb690d.md

- 2026-09-24 — Regeneron to Report Third Quarter 2026 Financial and Operating Results and Host Conference Call and Webcast on October 30, 2026: https://biopharmsignal.com/news/REGN/regeneron-to-report-third-quarter-2026-financial-and-operating-results-and-host--9bee1c65.md