By the end of the first quarter of 2025, Savara Inc. (SVRA, Financial) reported holding approximately $172.5 million in cash, cash equivalents, and short-term investments, with a total debt of around $29.5 million. The company achieved a significant milestone with the timely submission of the Biologics License Application (BLA) for MOLBREEVI to the FDA, aimed at treating autoimmune PAP, and requested a priority review. If granted, Savara anticipates a decision, known as the Prescription Drug User Fee Act (PDUFA) date, by the end of the year, setting the stage for a U.S. commercial launch in early 2026.
Furthermore, Savara plans to file the Marketing Authorization Application (MAA) in Europe and the U.K. by the close of 2025. With their robust financial position, bolstered by $172.5 million and opportunities for additional low-cost capital from recent debt financing, the company expects its current cash reserves to last into the second half of 2027, extending well past the potential U.S. launch.
