Shares of Savara fell over 30% in intraday trading on May 27, 2025, after the company announced that the FDA issued a Refusal to File letter for its Biologics License Application for Molbreevi, its lead drug candidate for autoimmune PAP. Savara said the FDA found the submission “not sufficiently complete” for review, citing issues with the CMC section of the application. The company was unable to specify what data was missing, or why the deficiencies weren’t addressed prior to submission.
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