Molgramostim: autoimmune PAP FDA decision
Savara lists November 22, 2026 for the MOLBREEVI BLA after a three-month extension. Its August business update confirms the target; October materials still describe molgramostim as investigational. FDA approval is separate from EMA/MHRA reviews and presentation of IMPALA analyses.
What matters
Follow the exact application, indication and requested label. An FDA decision concerns the drug program, while the company’s stock also reflects its other assets and business.
- MOLBREEVI is a proposed trade name, not proof of approval.
- Do not reuse the superseded August target or confuse U.S. FDA action with European or U.K. authorization.
Primary evidence
FDA target 2026-11-22 — not a guaranteed decision date
Potential outcome market
Will FDA approve molgramostim inhalation solution for autoimmune pulmonary alveolar proteinosis by a separately fixed evidence cutoff?
This event is research, not a listed market. A market needs a precise question, resolution rules and liquidity before trading opens.