Also known as: Savara
Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Its lead program is molgramostim inhalation solution (MOLBREEVI) for autoimmune pulmonary alveolar proteinosis.
Savara resubmits BLA with near-term FDA decision expected; Sarepta reports $331M in Q1 net product revenue but Elevidys sales continue to decline; AstraZeneca stock falls ahead of July 2026 earnings release.
The FDA extended by three months the review period for Savara's MOLBREEVI biologics license application in autoimmune pulmonary alveolar proteinosis, moving the PDUFA date to Nov. 22, 2026. Savara had previously said the FDA filed the application after a resubmission tied to manufacturing data and a transfer to Fujifilm.
Savara has submitted a Biologics License Application for MOLBREEVI to the FDA with Priority Review status, targeting an August 22, 2026 decision date for treating autoimmune pulmonary alveolar proteinosis.
The FDA has accepted Savara's Biologics License Application for Molbreevi in autoimmune pulmonary alveolar proteinosis, granted priority review, and set a PDUFA action date of August 22, 2026. The company plans to file marketing authorization applications in the EU and UK by the end of March.
The FDA has filed Savara's biologics license application for MOLBREEVI to treat autoimmune pulmonary alveolar proteinosis, granting Priority Review with a target action date of August 22, 2026.
Savara Inc. announced the FDA has accepted its Biologics License Application for Molbreevi to treat autoimmune pulmonary alveolar proteinosis, granting Priority Review with a PDUFA action date of August 22, 2026.
Savara Inc. announced the FDA has filed for review the BLA for MOLBREEVI to treat autoimmune PAP, granting Priority Review with a PDUFA action date of August 22, 2026. The therapy could become the first approved treatment for this rare lung disease.
Savara Inc. announced the FDA has accepted its resubmitted Biologics License Application for MOLBREEVI, a treatment for autoimmune pulmonary alveolar proteinosis, with Priority Review granted and a target decision date of August 22, 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06546098 |
Molgramostim Nebulizer Solution Expanded Access Program Protocol |
AVAILABLE | |
| NCT06431776 |
Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP). |
RECRUITING | PHASE3 |
| NCT04544293 |
Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT03597347 |
Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection |
TERMINATED | PHASE2 |
| NCT03482752 |
Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis |
TERMINATED | PHASE3 |
| NCT03421743 |
Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection |
COMPLETED | PHASE2 |
| NCT03181932 |
AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis |
COMPLETED | PHASE3 |
| NCT02702180 |
Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis |
COMPLETED | PHASE2 |
| NCT02468908 |
Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects |
COMPLETED | PHASE1 |
| NCT01746095 |
Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients |
COMPLETED | PHASE2 |
