Savara Submits FDA Application for Molbreevi to Treat Rare Lung Disease
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.
Savara Inc. has submitted a Biologics License Application (BLA) for MOLBREEVI to the FDA, receiving Priority Review with a PDUFA date set for August 22, 2026. MOLBREEVI is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) targeting autoimmune pulmonary alveolar proteinosis.
MOLBREEVI has received FDA's fast track, breakthrough therapy, and orphan drug designations, which expedite the approval process. The drug is an inhaled formulation of recombinant human GM-CSF administered once daily by inhalation via a high efficiency nebulizer, the eFlow Nebulizer System (PARI Pharma GmbH).
Savara plans to submit applications to the European Medicines Agency (EMA) and the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) by the end of Q1 2026. Pulmonary alveolar proteinosis (PAP) is a rare lung disease characterized by the accumulation of surfactant in the alveoli (or air sacs) of the lungs.
As of December 31, 2025, Savara reported approximately $236 million in cash and short-term investments, with access to an additional $150 million in non-dilutive capital upon FDA approval. The company reported $20.9 million in R&D expenses for Q4 2025, with total annual R&D expenses rising by 4.3% year-over-year.
Savara is advancing U.S. commercial planning, with a market development team expected to be fully onboarded by Q2. VR Adviser increased its position in Savara by 1,059,332 shares during Q4, bringing its total holdings to 13,740,375 shares valued at $82.9 million. Savara represents 4.1% of VR Adviser's total assets under management.
On February 10, 2026, the Compensation Committee of Savara's Board of Directors granted inducement awards to a new employee consisting of options to purchase 7,500 shares of the Company's common stock and restricted stock units (RSUs) covering 7,500 shares of the Company's common stock. The options have an exercise price of $5.27 per share, the closing trading price of the Company's common stock on the NASDAQ Global Market on the grant date.