PDUFAApproval decision
MOLBREEVI (Molgramostim)
Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
SVRASavaraExpected catalystNovember 22, 2026Company guidance: Nov 22, 2026
Catalyst overview
Event details
- Drug or asset
- MOLBREEVI (Molgramostim)
- Development stage
- PDUFA
- Event type
- Approval decision
- Indication
- Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Research signalsBig moverHigh management interest
Research summary
What is being tracked?
This catalyst tracks a PDUFA approval decision for MOLBREEVI (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP). The expected timing is based on the latest available company guidance and may change.
Development notes
08/12/26:- PDUFA remains November 22, 2026. ATS data improved lung function. U.K. decision is Q4 2026; EMA is Q1 2027.
Verification
Primary source
Confirm timing and program details against the company announcement or filing.