05:00 PM EST, 03/06/2026 (MT Newswires) -- Savara (SVRA) said Friday it received a letter from the US Food and Drug Administration indicating that an Advisory Committee meeting is not planned for the Biologics License Application for Molbreevi.

The company said the review is ongoing with a Prescription Drug User Fee Act target action date of Aug. 22.

Savara said it submitted a marketing authorization application, or MAA, to the European Medicines Agency for Molbreevi to treat autoimmune pulmonary alveolar proteinosis. The company said it is on track to file an MAA with the UK's Medicines and Healthcare products Regulatory Agency by Q1.