Business Wire·Mar 13, 2026, 8:05 AM ET

Savara Reports Fourth Quarter and Year End 2025 Financial Results and Provides Business Update

SVRA

Savara Inc. filed a Biologics License Application (BLA) for MOLBREEVI with the U.S. FDA for autoimmune pulmonary alveolar proteinosis (PAP).
The FDA granted Priority Review status with a Prescription Drug User Fee Act (PDUFA) target date set for August 22, 2026.
The FDA indicated that an Advisory Committee meeting is not planned for the BLA review.
Marketing Authorization Applications (MAAs) were submitted to the European Medicines Agency (EMA) and the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA).
MOLBREEVI holds Orphan Drug Designations from the FDA and EMA, along with Innovation Passport and Promising Innovative Medicine designations from the MHRA.
As of December 31, 2025, the company reported $235.7 million in cash, cash equivalents, and short-term investments.
The company has access to up to approximately $150 million in non-dilutive capital contingent upon FDA approval of MOLBREEVI.
Net loss for the fourth quarter of 2025 was $32.2 million, or $0.13 per share, compared to $29.0 million, or $0.13 per share, in the same period of 2024.
Research and development expenses for Q4 2025 were $20.9 million, down from $23.3 million in Q4 2024.
General and administrative expenses for Q4 2025 were $12.5 million, up from $7.8 million in Q4 2024 due to workforce expansion and commercial activities.
Net loss for the full year 2025 was $118.8 million, or $0.53 per share, compared to $95.9 million, or $0.48 per share, in 2024.
Full-year 2025 research and development expenses increased 4.3% to $81.4 million, driven by regulatory affairs costs related to the BLA submission.
Full-year 2025 general and administrative expenses increased 68.0% to $42.1 million, primarily due to higher personnel compensation and stock awards.
Commercial planning is underway with the onboarding of a market development team expected to be completed in the second quarter of 2026.