Savara says FDA extended review for Molgramostim BLA

Savara (SVRA) “announced that the FDA has extended the review period for the molgramostim BLA in autoimmune PAP by three months. The Agency is reviewing the molgramostim BLA under Priority Review and the new PDUFA target action date is November 22, 2026. The FDA determined that the Company’s responses to recent information requests by the Agency constituted a major amendment to the BLA, resulting in a three-month extension of the PDUFA date. The Agency did not cite any safety, efficacy, or manufacturing concerns in their correspondence. This extension allows the FDA additional time to complete their review of the BLA, including recently submitted materials related to information requests.”