Savara receives refusal to file (rtf) letter from the u.s. food and drug administration (fda) for the biologics license application (bla) for molbreevi* to treat patients with autoimmune pulmonary alveolar proteinosis (autoimmune pap)

Langhorne, pa.--(business wire)--savara inc. (nasdaq: svra) (the company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced that the company received an rtf letter from the fda for the bla of molbreevi as a therapy to treat patients with autoimmune pap. upon preliminary review, the fda determined that the bla submitted in march 2025 was not sufficiently complete to permit substantive review and requested additional data related to chemistry, manuf.
SVRA Ratings Summary
SVRA Quant Ranking