LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) reported fourth-quarter and full-year 2025 financial results while advancing its MOLBREEVI program, including a filed Biologics License Application with the U.S. Food and Drug Administration and a target decision date of August 22, 2026, the company announced.
The FDA granted Priority Review for the application and indicated no advisory committee meeting is planned, while Savara also submitted marketing applications to regulators in Europe and the United Kingdom.
Chief Executive Officer Matt Pauls said the company is preparing for commercialization alongside regulatory progress.
“With the filing of the BLA, an assigned PDUFA date of August 22nd, and submission of the MAAs we have strong momentum,” Pauls said, adding that U.S. commercial planning is underway with a market development team expected to be in place by the second quarter.
MOLBREEVI, the company’s lead product candidate, has received Fast Track, Breakthrough Therapy, and Orphan Drug designations from the FDA and European Medicines Agency, as well as Innovation Passport and Promising Innovative Medicine designations in the United Kingdom.
The therapy is being developed for autoimmune pulmonary alveolar proteinosis, a rare lung disease in which surfactant accumulates in the alveoli due to impaired immune cell function, leading to breathing difficulties and potential long-term complications.
Savara reported a fourth-quarter 2025 net loss of $32.2 million, or $0.13 per share, compared with a net loss of $29.0 million, or $0.13 per share, in the same period a year earlier.
Research and development expenses decreased to $20.9 million in the quarter from $23.3 million a year earlier, while general and administrative expenses increased to $12.5 million from $7.8 million.
For the full year, the company reported a net loss of $118.8 million, or $0.53 per share, compared with $95.9 million, or $0.48 per share, in 2024.
Research and development expenses for 2025 rose to $81.4 million from $78.0 million, driven by regulatory, manufacturing, and program-related costs associated with MOLBREEVI, partially offset by lower clinical expenses.
General and administrative expenses increased to $42.1 million from $25.0 million, reflecting higher personnel costs, expanded commercial activities, and increased spending on patient advocacy and medical affairs.
As of December 31, 2025, Savara reported $235.7 million in cash, cash equivalents, and short-term investments.
The company said it has access to up to an additional $150 million in non-dilutive capital through debt and royalty arrangements upon potential FDA approval of MOLBREEVI.
“With approximately $236 million in cash and access to up to an additional $150 million in non-dilutive capital… we can fund global commercial launch activities,” Pauls said.
Savara said it is focused on preparing for a potential global launch of MOLBREEVI, which is delivered via an investigational nebulizer system designed for inhalation of large-molecule therapies.
The company operates as a clinical-stage biopharmaceutical firm focused on rare respiratory diseases, with MOLBREEVI currently in Phase 3 development.
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