SVRA News & Events

Savara announced that it has received the Day 74 Letter from the FDA which indicated that an Advisory Committee meeting is not planned for the MOLBREEVI Biologics License Application and the review is ongoing with a Prescription Drug User Fee Act target action date of August 22, 2026. Additionally, the company recently submitted the MAA to the EMA for MOLBREEVI for the treatment of autoimmune PAP and is on track to submit the MAA to the U.K.'s MHRA by the end of Q1 2026.

Savara announced the FDA has filed for review the BLA for Molbreevi as a therapy to treat patients with autoimmune PAP. The FDA granted Priority Review with a PDUFA action date of August 22, 2026.

Savara announced the FDA has filed for review the BLA for Molbreevi as a therapy to treat patients with autoimmune PAP. The FDA granted Priority Review with a PDUFA action date of August 22.