Welcome to our dedicated page for Savara news (Ticker: SVRA), a resource for investors and traders seeking the latest updates and insights on Savara stock.
Savara Inc. (Nasdaq: SVRA) is a clinical stage biopharmaceutical company focused on rare respiratory diseases, with its lead program MOLBREEVI in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The Savara news feed highlights regulatory, clinical, financial, and corporate developments that shape the company’s progress toward potential approval and commercialization of its investigational therapy.
News items commonly include updates on the Biologics License Application (BLA)
Investors and observers can follow announcements on intellectual property, including European Patent Office decisions related to the liquid formulation of MOLBREEVI and the drug–device combination with the proprietary investigational eFlow® Nebulizer System. Additional news covers capital markets activity, such as underwritten public offerings of common stock and pre-funded warrants, as well as a royalty funding agreement tied to potential future U.S. net sales of MOLBREEVI.
The news stream also features corporate and partnering updates, including Savara’s selection of PANTHERx Rare Pharmacy as the exclusive U.S. specialty pharmacy for MOLBREEVI, and participation in major healthcare and investor conferences. For those tracking SVRA, this page provides a centralized view of Savara’s public announcements related to clinical data presentations, regulatory interactions, financing events, and commercialization planning for its rare respiratory disease program.
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.
Savara (Nasdaq: SVRA) announced inducement equity awards granted January 15, 2026 to two newly hired employees under the Savara 2021 Inducement Equity Incentive Plan pursuant to NASDAQ Rule 5635(c)(4). The awards total 17,500 stock options and 12,500 restricted stock units (RSUs). Options carry an exercise price of $5.88 (closing price on the grant date), a 10-year term, and vest at 1/16th per quarterly anniversary of the employee’s first day of employment. The RSUs vest in full after two years subject to continued employment. The grants were described as inducements material to the employees’ acceptance of employment.
Savara (NASDAQ: SVRA) announced an exclusive U.S. distribution agreement with PANTHERx Rare Pharmacy for MOLBREEVI. Savara submitted the MOLBREEVI BLA to the FDA in December 2025 and requested Priority Review. If approved, PANTHERx will dispense MOLBREEVI nationwide using its RxARECARE model and the eFlow® Nebulizer System, offering clinical case management, education, and financial and insurance assistance. PANTHERx reported 95.45% of its patients have no unresolved barriers at annual assessment.