NasdaqGS:SVRABiotechs
Savara’s FDA Review Extension Keeps Molgramostim Thesis Intact But Delayed
FDA extends Priority Review for Savara’s molgramostim BLA in autoimmune PAP by three months following a major amendment.
Regulator cites no new safety, efficacy, or manufacturing concerns in connection with the extension.
Extension reflects ongoing review activity for Savara’s lead product candidate, ticker NasdaqGS:SVRA.
Savara, listed on NasdaqGS:SVRA, focuses on therapies for rare respiratory diseases, with molgramostim as its most advanced program targeting autoimmune pulmonary alveolar...