LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) said it remains on track to resubmit its Biologics License Application for MOLBREEVI, a potential first-in-class treatment for autoimmune pulmonary alveolar proteinosis, in December and will seek priority review from the U.S. Food and Drug Administration. The company also plans to file marketing authorization applications in Europe and the United Kingdom during the first quarter of 2026.
The update came as Savara reported third-quarter financial results and detailed recent financing moves that significantly increased its liquidity. A $149.5 million equity offering—adding roughly $140 million to the $124.4 million in cash and investments reported at the end of September—combined with a new $75 million royalty funding agreement to support a potential commercial launch of MOLBREEVI.
“Our recent strategic financings further strengthen our balance sheet and allow us to accelerate preparations for the potential commercialization of MOLBREEVI,” said CEO Matt Pauls. He noted that new data presented at this year’s European Respiratory Society meeting continue to support the therapy’s efficacy in autoimmune PAP, a rare condition with no approved pharmacologic treatments in the U.S. or Europe.
Savara reported a third-quarter net loss of $29.6 million, compared with $24.2 million a year earlier. Research and development expenses increased modestly to $20.6 million, largely driven by regulatory and manufacturing activities tied to the MOLBREEVI program. General and administrative expenses rose to $9.6 million, reflecting added personnel and early commercial planning.
Autoimmune PAP is caused by antibodies that neutralize GM-CSF, preventing immune cells in the lungs from clearing excess surfactant. The buildup impairs gas exchange and can lead to chronic shortness of breath, fatigue, and long-term complications including lung fibrosis and potential transplant.
With expanded funding and regulatory submissions approaching, Savara said it is focused on positioning MOLBREEVI as the first approved treatment for a disease that currently relies on procedures such as whole lung lavage rather than drug therapy.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.