Savara (SVRA) said late Wednesday it has completed submission of a biologics license application to the US Food and Drug Administration for Molbreevi to treat autoimmune pulmonary alveolar proteinosis, a rare lung disease.
Savara requested priority review, which, if granted, will shorten the FDA's review to six months from the standard 10 months following the regulator's acceptance of the application, Chief Executive Matt Pauls said in a statement. The company remains on track with its commercial preparations to support a possible launch of the drug in early 2026, he added.
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