Savara submits BLA for MOLBREEVI with FDA priority review set for August

Savara Inc. (NASDAQ: SVRA) filed a Biologics License Application with the FDA for MOLBREEVI, its treatment for autoimmune pulmonary alveolar proteinosis. The FDA granted priority review with a Prescription Drug User Fee Act date of August 22, 2026, and indicated no advisory committee meeting is planned.

The biopharmaceutical company also submitted marketing authorization applications to the European Medicines Agency and the U.K. Medicines and Healthcare Products Regulatory Agency. MOLBREEVI has received Fast Track and Breakthrough Therapy designations from the FDA, as well as Orphan Drug designations from both the FDA and EMA.

Savara reported a net loss of $118.8 million for 2025, compared to $95.9 million in 2024. Research and development expenses increased 4.3% to $81.4 million, primarily due to regulatory affairs and quality assurance costs related to the BLA submission. General and administrative expenses rose 68.0% to $42.1 million, driven by workforce expansion and commercial activities.

The company held $235.7 million in cash, cash equivalents and short-term investments as of December 31, 2025. According to the company statement, it has access to up to an additional $150 million in non-dilutive capital through debt and royalty structures upon MOLBREEVI approval.

Autoimmune PAP is a rare lung disease characterized by abnormal surfactant buildup in the alveoli due to neutralized granulocyte-macrophage colony-stimulating factor. MOLBREEVI is a recombinant human GM-CSF delivered via an investigational nebulizer system.

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