By Katherine Hamilton
Savara shares fell after the Food and Drug Administration said its drug is not ready for a full review.
The stock dropped 35% to $1.85 in pre-market trading Tuesday.
The Langhorne, Pa., biopharmaceutical company said Tuesday it received a refusal-to-file letter from the FDA for the biologics license application for Molbreevi as a therapy to treat patients with autoimmune pulmonary alveolar proteinosis.
The FDA determined the license application, which was submitted in March, was not sufficiently complete and needed additional data on chemistry, manufacturing and controls. The refusal to file was not the result of safety concerns and the FDA did not request additional efficacy studies, Savara said.
Savara plans to request a Type A meeting with the FDA within the next 30 days. It is currently generating the data requested by the FDA, and expects to resubmit its application in the fourth quarter of 2025, CHief Executive Matt Pauls said.
The letter does not impact previous designations granted by regulators by Molbreevi.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
May 27, 2025 08:56 ET (12:56 GMT)
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