# Gefurulimab (Klygefa) PDUFA Event: Generalized myasthenia gravis

Canonical URL: https://biopharmsignal.com/pdufa-calendar/AZN/gefurulimab-generalized-myasthenia-gravis

Ticker: AZN

Company: AstraZeneca PLC

Event date: 2026-12-31

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: BLA

FDA decision expected. The BLA is under FDA review. The company has not publicly disclosed an exact PDUFA date; the Q4 timing is retained as an estimate rath...

## Event Timeline

### Q4 2026 (estimated) — FDA decision expected

The BLA is under FDA review. The company has not publicly disclosed an exact PDUFA date; the Q4 timing is retained as an estimate rather than a confirmed target action date.

[AstraZeneca — Klygefa regulatory update](https://www.astrazeneca.com/media-centre/press-releases/2026/klygefa-recommended-for-approval-in-the-eu.html)

### September 18, 2026 — EMA’s CHMP issued a positive opinion

CHMP recommended gefurulimab as an add-on to standard therapy for adults with anti-AChR-antibody-positive generalized myasthenia gravis.

[AstraZeneca — CHMP opinion](https://www.astrazeneca.com/media-centre/press-releases/2026/klygefa-recommended-for-approval-in-the-eu.html)

### July 27, 2026 — PREVAIL Phase 3 results were published

The PREVAIL randomized trial reported a statistically significant improvement in MG-ADL at week 26 versus placebo.

[AstraZeneca — PREVAIL publication summary](https://www.astrazeneca.com/media-centre/press-releases/2026/klygefa-recommended-for-approval-in-the-eu.html)

## Related Pages

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

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

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

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