MOLBREEVI (molgramostim inhalation) is a Savara program in Autoimmune pulmonary alveolar proteinosis (aPAP) BLA. Its PDUFA date is Nov 22, 2026, the FDA's goal date to complete review of the application. Every date links its source.
Indication under review: Autoimmune pulmonary alveolar proteinosis (aPAP) BLA. Sponsor: Savara (SVRA). Market-cap tier at the time we tracked it: Small. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
When is MOLBREEVI (molgramostim inhalation)'s next FDA decision or readout?
MOLBREEVI (molgramostim inhalation)'s PDUFA date is Nov 22, 2026. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
What happened at MOLBREEVI (molgramostim inhalation)'s most recent FDA decision?
No FDA decision for MOLBREEVI (molgramostim inhalation) is in our archive yet.
What is MOLBREEVI (molgramostim inhalation) used for?
In our records MOLBREEVI (molgramostim inhalation) is under review or in development for Autoimmune pulmonary alveolar proteinosis (aPAP) BLA.
Who makes MOLBREEVI (molgramostim inhalation)?
Savara (SVRA).
Where does this data come from?
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.
Facts and dates only; not investment advice. Verify against primary FDA, SEC
and company filings. pdufa.bio is not affiliated with the FDA.
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