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Savara Inc. develops therapies for rare respiratory diseases, with a lead program in molgramostim inhalation solution, conditionally named MOLBREEVI, for autoimmune pulmonary alveolar proteinosis. Molgramostim is a recombinant human GM-CSF delivered through an investigational eFlow Nebulizer System developed for inhalation of the large-molecule therapy.
Recurring company developments include clinical data from the IMPALA-2 program, regulatory submissions and agency-review updates in the U.S., Europe and the U.K., financial results, financing arrangements, equity inducement grants and investor conference participation. Savara's updates also note that MOLBREEVI is not approved in any indication.
Savara (Nasdaq: SVRA) will present new clinical data at the American Thoracic Society (ATS) International Conference in Orlando, May 17-20, 2026. Presentations feature Phase 3 IMPALA-2 results for molgramostim inhalation solution in autoimmune pulmonary alveolar proteinosis (aPAP), including open-label data.
The company has one oral presentation (May 18, 2026), two poster presentations (May 19–20, 2026), and will host an ATS industry theater on aPAP that includes expert and patient perspectives.
Savara (Nasdaq: SVRA) announced the U.K. Medicines and Healthcare Products Regulatory Agency has accepted the MOLBREEVI Marketing Authorisation Application for autoimmune pulmonary alveolar proteinosis under Accelerated Review.
The MHRA acceptance qualifies for a 150-day assessment and targets a decision in Q4 2026; the FDA BLA has a PDUFA date of August 22, 2026 and the EMA CHMP decision is expected in Q1 2027. MOLBREEVI holds multiple expedited and orphan designations.
Savara (NASDAQ: SVRA) announced the EMA validated its Marketing Authorization Application for MOLBREEVI in autoimmune pulmonary alveolar proteinosis (autoimmune PAP), initiating CHMP review with a decision expected in Q1 2027. The MOLBREEVI BLA is under FDA Priority Review with an August 22, 2026 action date. The company also submitted to the MHRA in March 2026. MOLBREEVI holds Orphan Drug designations from FDA and EMA and MHRA Innovation Passport and Promising Innovative Medicine recognitions.
Savara (Nasdaq: SVRA) reported that the FDA accepted the MOLBREEVI BLA with Priority Review and set a PDUFA date of August 22, 2026. MAAs were submitted to the EMA and MHRA. As of December 31, 2025, cash and short-term investments were $235.7M, with access to up to $150M of non-dilutive capital upon FDA approval.
Financials: Q4 net loss was $32.2M and FY2025 net loss was $118.8M; R&D was $81.4M and G&A increased to $42.1M.
Savara (Nasdaq: SVRA) received a Day 74 letter from the FDA indicating no Advisory Committee is planned for the MOLBREEVI BLA and the review continues toward a PDUFA target action date of August 22, 2026. The company submitted an MAA to the EMA for autoimmune PAP and remains on track to submit to the UK MHRA by end of Q1 2026. MOLBREEVI holds FDA Fast Track, Breakthrough Therapy and Orphan Drug designations, EMA Orphan Drug designation, and MHRA Innovation Passport and PIM designations. The update summarizes regulatory progress and timelines for potential approvals in the U.S., EU and UK.
Savara (Nasdaq: SVRA) said members of management will appear in a fireside chat at the 2026 Citizens Life Sciences Conference on Wednesday, March 11, 2026 at 10:10 AM ET in Miami, FL. The session will be webcast live with a replay archived for 90 days on the company website.
Savara (Nasdaq: SVRA) announced the U.S. Food and Drug Administration has filed the BLA for MOLBREEVI to treat autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The FDA granted Priority Review with a PDUFA target action date of August 22, 2026.
The company plans to submit MAAs to EMA and MHRA by end of Q1 2026. MOLBREEVI holds Fast Track, Breakthrough Therapy, and Orphan Drug designations, plus UK Innovation Passport and PIM designations, and is positioned as a potential first and only approved therapy for autoimmune PAP in the U.S. and Europe.
Savara (Nasdaq: SVRA) granted inducement equity awards to a new employee on February 10, 2026. The awards include options to purchase 7,500 shares and 7,500 restricted stock units (RSUs).
Options carry a $5.27 exercise price, a 10-year term, quarterly vesting over four years for options, and RSUs vesting in full after two years, all subject to continued employment.
Savara (Nasdaq: SVRA) said members of management will hold one-on-one meetings and participate in fireside chats at two investor healthcare conferences in February 2026.
Fireside chat dates: Guggenheim Emerging Outlook: Biotech Summit on February 11 at 12:30pm ET and Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25 at 9:20am ET. Live webcasts and replays will be on the company Events & Presentations page and archived for 90 days.
Savara (Nasdaq:SVRA) amended its loan and security agreement with Hercules Capital (NYSE:HTGC) to make up to $75 million of additional debt available upon U.S. FDA approval of MOLBREEVI, an investigational therapy for autoimmune pulmonary alveolar proteinosis.
Combined with a previously announced $75 million royalty financing, the company would have access to approximately $150 million of non-dilutive capital to support a potential MOLBREEVI launch. Savara resubmitted the MOLBREEVI BLA in December 2025, is targeting potential approval in 3Q 2026 if Priority Review is granted, and expects to file EU/UK MAA by end of 1Q 2026.