Savara refiled MOLBREEVI BLA after FDA rejection, raised $140M, granted Priority Review

Filed March 13, 2026 · Period ending December 31, 2025 · Compared to 10-K Mar 27, 2025 · ~1 min read

Key Changes

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  FDA refused to file MOLBREEVI BLA in May 2025 citing Chemistry, Manufacturing, and Controls deficiencies; company resubmitted in December 2025 and received Priority Review in February 2026.

  Business: BLA filing timeline verify on EDGAR →
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  Raised $140M through October 2025 equity offering (28.5M shares at $4.20) and secured $75M royalty deal contingent on FDA approval by March 2027, reducing future economics but strengthening near-term balance sheet.

  MD&A: Capital raises verify on EDGAR →
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  Switched primary drug substance supplier from GEMA to Fujifilm for BLA resubmission after FDA alignment meeting; completed three commercial-scale validation batches at Fujifilm.

  Business: Manufacturing strategy verify on EDGAR →