-- Day 74 Letter Received from the U.S. Food and Drug Administration (FDA) Indicated the Agency Has No Plans to Convene an Advisory Committee --
-- Company has Submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) --
-- Submission of the MAA to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Remains on Track by the End of Q1 2026 --
Savara Inc. (the "Company") (NASDAQ:SVRA), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced that it has received the Day 74 Letter from the FDA which indicated that an Advisory Committee meeting is not planned for the MOLBREEVI Biologics License Application (BLA) and the review is ongoing with a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026.
Additionally, the Company recently submitted the MAA to the EMA for MOLBREEVI for the treatment of autoimmune PAP and is on track to submit the MAA to the U.K.'s MHRA by the end of Q1 2026.
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