Savara's Molbreevi BLA Accepted for FDA Priority Review with August 2026 Action Date

Savara Inc. announced the FDA has filed for review the Biologics License Application for MOLBREEVI as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis (PAP). The FDA granted Priority Review with a PDUFA action date of August 22, 2026.

FDA Priority Review designation directs overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard review applications.

In addition to Fast Track and Breakthrough Therapy Designations, MOLBREEVI has been granted Orphan Drug Designations for the treatment of autoimmune PAP by the FDA and the EMA, as well as Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK's MHRA.

Savara Inc is a biopharmaceutical company focused on developing novel therapies for rare respiratory diseases. Its primary program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). The company has a market capitalization of approximately $1.13 billion, reflecting its niche focus and potential growth opportunities in the rare disease market.

The company currently reports zero revenue, indicating its developmental stage focus. The EPS stands at -0.53, highlighting ongoing losses typical of biotech firms in the R&D phase. Operating and net margins are negative, with median operating margin at -10,968.52% and net margin at -16,664.81%, underscoring the high costs associated with drug development.

On the balance sheet front, Savara exhibits strong liquidity with a robust current ratio of 7.65, suggesting ample liquidity to cover short-term liabilities. The debt-to-equity ratio is low at 0.32, indicating conservative leverage. A high cash ratio of 7.42 further supports its financial stability.