Savara

SVRA

Market cap $1.2B

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today 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 cons.

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the acceptance of one oral presentation and two poster presentations at the ATS International Conference in Orlando, Florida, May 17-20, 2026. Oral Presentation Title: Molgramostim Improves Exercise Distance and Duration in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from the IMPALA-2 Phase 3 Clinical Trial Mini Sympo.

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that the MHRA has accepted the submission of the MOLBREEVI MAA for the treatment of autoimmune PAP in the U.K. The MAA was accepted under Accelerated Review and qualifies for a 150-day assessment duration. A decision on the application is expected in Q4 2026. In the U.S., the FDA is reviewing the MOLBREEVI BLA under Priority.

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that the EMA has validated the submission of the MOLBREEVI MAA in autoimmune PAP; the submission will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP). In the U.S., the FDA is reviewing the MOLBREEVI BLA under Priority Review with an August 22, 2026 Action Date. “EMA's validation of the MOLBREEVI M.

VR Adviser Bought 1,059,332 shares of Savara. Post-trade, VR Adviser held 13,740,375 shares valued at $82.9 million Savara represents 4.1% of the fund's AUM.

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2025 and provided a business update. “Over the last year, we significantly advanced the MOLBREEVI development program,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “With the filing of the BLA, an assigned PDUFA date of August 22nd, and submiss.

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (the “Company”) (Nasdaq: SVRA), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today 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 (BLA) and the review is ongoing with a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026. Additionally, the Company recently submitt.

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the “Company”), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that members of the management team will participate in a fireside chat at the 2026 Citizens Life Sciences Conference on Wednesday, March 11th at 10:10am ET in Miami, FL. The live webcast and subsequent replay will be available on the “Events & Presentations” section of the Company's corporate website and will be archiv.

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, 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. “The FDA's filing of the BLA marks another significant milestone for Savara and the autoimmune PAP community and brings us one step closer to a potential.

LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the grant of inducement awards to a new employee. On February 10, 2026, the Compensation Committee of Savara's Board of Directors granted the inducement awards to a new employee who recently joined the Company. The inducement awards consist of options to purchase 7,500 shares of the Company's common stock and restricted stock units (RSUs).