LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) advanced regulatory filings for its lead rare lung disease therapy MOLBREEVI while reporting a wider first-quarter loss as the company ramps up manufacturing and commercial preparations ahead of a potential U.S. launch.
The clinical-stage biopharmaceutical company disclosed that the U.S. Food and Drug Administration accepted its biologics license application for MOLBREEVI in autoimmune pulmonary alveolar proteinosis, or autoimmune PAP, with a Prescription Drug User Fee Act target action date of November 22, 2026.
The company also reported that marketing applications have been validated by European and U.K. regulators, with decisions expected in the fourth quarter of 2026 in the United Kingdom and the first quarter of 2027 in the European Union.
Savara is positioning MOLBREEVI as a potential first approved therapy for autoimmune PAP, a rare respiratory disorder in which surfactant accumulates in the lungs and impairs oxygen exchange.
The company reported a net loss of $37.3 million, or $0.15 per share, for the quarter ended March 31, compared with a loss of $26.6 million, or $0.12 per share, a year earlier.
Research and development expenses rose 22% to $23.4 million, driven primarily by manufacturing-related activities tied to the MOLBREEVI program, including chemistry, manufacturing, and controls work with its drug substance manufacturer.
General and administrative expenses increased 68% to $15.6 million, largely due to higher personnel and stock-based compensation costs as the company expands commercial infrastructure ahead of a possible launch.
Savara ended the quarter with approximately $202.8 million in cash, cash equivalents, and short-term investments, alongside about $30.1 million in debt.
Chief Executive Matt Pauls indicated the company expects additional financing flexibility if the therapy secures FDA approval.
“With a PDUFA action date of November 22nd, U.S. commercial planning momentum is building,” Pauls stated in the earnings release.
Savara also disclosed that additional data from the Phase 3 IMPALA-2 clinical trial, including results from an ongoing open-label treatment period, will be presented at the American Thoracic Society International Conference in May.
Rare disease drug developers have increasingly focused on specialized pulmonary and immunology markets where smaller patient populations can support premium pricing and accelerated regulatory pathways.
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