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pdufa.bio

Molgramostim

Updated ยทnext FDA decision on the calendar

Molgramostim 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.

SVRA catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Molgramostim is marketed as MOLBREEVI (molgramostim inhalation); the events below include those tracked under the brand name. Indication under review: Autoimmune pulmonary alveolar proteinosis (aPAP) BLA. Sponsor: Savara (SVRA). Market-cap tier at the time we tracked it: Small. We track 2 catalyst events for this program: 2 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.

Catalyst history

PDUFA · Nov 22, 2026SVRAReadout · Jun 2027SVRA

Questions

When is Molgramostim's next FDA decision or readout?

Molgramostim'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 Molgramostim's most recent FDA decision?

No FDA decision for Molgramostim is in our archive yet.

What is Molgramostim used for?

In our records Molgramostim is under review or in development for Autoimmune pulmonary alveolar proteinosis (aPAP) BLA.

Who makes Molgramostim?

Savara (SVRA).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.