Savara Inc SVRA
Savara Inc (Nasdaq: SVRA) is a respiratory drug developer. Its lead program, MOLBREEVI (molgramostim inhalation solution), is in Phase 3 for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). Its next catalyst on record is MOLBREEVI: FDA PDUFA target action date for BLA (extended after a major amendment) (November 22, 2026).
Upcoming catalysts
- November 22, 2026MOLBREEVI — FDA PDUFA target action date for BLA (extended after a major amendment)
The FDA determined that the Company's responses to recent information requests by the Agency during their review constituted a major amendment to the BLA, resulting in a three-month extension of the Prescription Drug User Fee Act ("PDUFA") target action date to November 22, 2026.
Next further out: MOLBREEVI — MHRA accelerated review of UK MAA (150-day assessment) (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| MOLBREEVI (molgramostim) | autoimmune PAP (BLA under Priority Review; EMA MAA and UK MHRA MAA under review) | protein/peptide | Phase 3 |
Recent results and decisions
- Jan 9, 2026submitted Deck timeline shows the MOLBREEVI BLA as resubmitted with Fuji as drug substance manufacturer; no date or PDUFA date stated.
BLA Resubmitted with Fuji as DS Manufacturer
Filing - Oct 29, 2025met IMPALA-2 met its primary endpoint of DLco% change at Week 24 (p=0.0007), recapped in the deck.
Primary endpoint was change from baseline to Week 24 in DLco% (p=0.0007)
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 respiratory companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.