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 inducement equity grants to new hires on April 14, 2026. The Compensation Committee granted awards to 24 new employees under the 2021 Inducement Equity Incentive Plan pursuant to NASDAQ Rule 5635(c)(4).
The inducement package totals 18,500 stock options (exercise price $6.07, 10-year term), 141,000 RSUs (vest in full at two years) and 85,000 PSUs (vest on achieving a specified quarterly revenue target), each subject to continued employment and plan terms.
Savara (Nasdaq: SVRA) said the FDA extended the PDUFA target action date for its molgramostim BLA in autoimmune pulmonary alveolar proteinosis by three months to November 22, 2026.
The FDA classes the review as Priority Review, found the company's responses a major amendment, and did not cite safety, efficacy, or manufacturing concerns. Molgramostim retains Fast Track, Breakthrough Therapy, and Orphan Drug designations from the FDA, EMA orphan designation, and MHRA Innovation Passport and Promising Innovative Medicine status.
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.