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 that the New England Journal of Medicine (NEJM) will publish results from their pivotal Phase 3 IMPALA-2 clinical trial studying molgramostim inhalation solution for autoimmune pulmonary alveolar proteinosis (PAP).
The trial demonstrated statistically significant improvements in key metrics: DLco% increased by 9.8% vs 3.8% for placebo at Week 24 (p0.001), and 11.6% vs 4.7% at Week 48. Quality of life measures showed significant improvement with SGRQ Total score reduction of -11.5 points vs -4.9 points for placebo at Week 24. Exercise capacity improved with peak-METs showing a 1.1 vs 0.6 difference at Week 48.The treatment was well-tolerated with 98% of molgramostim patients completing the 48-week trial, and most adverse events were mild to moderate. The study represents the largest and longest Phase 3 trial conducted in autoimmune PAP patients.
Savara Inc. (Nasdaq: SVRA) announced the acceptance of three abstracts for poster presentation at the European Respiratory Society (ERS) Congress 2025, taking place September 27 – October 1 in Amsterdam. The presentations will focus on new data from the Phase 3 IMPALA-2 trial of Molgramostim, an inhaled treatment for autoimmune Pulmonary Alveolar Proteinosis (aPAP).
The company will present posters on the relationship between pulmonary gas transfer and quality of life, the efficacy of inhaled Molgramostim based on aPAP severity, and their partner TrilliumBiO will present on a new dried blood spot test for aPAP diagnosis. Additionally, Savara will host an Industry Evening Mini Symposium titled "Advances in Autoimmune Pulmonary Alveolar Proteinosis" featuring expert speakers discussing disease management and pathophysiology.
Savara (Nasdaq: SVRA) reported Q2 2025 financial results and provided updates on MOLBREEVI, its treatment for Autoimmune Pulmonary Alveolar Proteinosis (PAP). The company has aligned with the FDA on requirements for BLA resubmission with FUJIFILM Biotechnologies as the drug substance manufacturer, planned for December 2025. Marketing authorization applications to EMA and MHRA are anticipated in Q1 2026.
Financial highlights include a net loss of $30.4 million ($0.14 per share) in Q2 2025, compared to $22.2 million in Q2 2024. R&D expenses increased 17.8% to $20.8 million, while G&A expenses rose 92.3% to $10.7 million. The company reported $146.4 million in cash and short-term investments, believed sufficient to fund operations into Q1 2027.
Savara (Nasdaq: SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has granted inducement awards to two new employees. The awards, approved by the Compensation Committee on July 15, 2025, include options to purchase 20,000 shares of common stock at $2.29 per share and restricted stock units (RSUs) covering 20,000 shares.
The equity awards were granted under Savara's 2021 Inducement Equity Incentive Plan, complying with NASDAQ Rule 5635(c)(4). The options have a 10-year term with quarterly vesting over four years, while RSUs fully vest after two years, both subject to continued employment.
Savara Inc. (SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has announced its participation in the upcoming Jefferies Global Healthcare Conference. The company's management team will conduct one-on-one meetings and deliver a presentation on June 4, 2025, at 9:20 AM ET. Investors can access the live webcast and replay of the presentation through the "Events & Presentations" section of Savara's corporate website, where it will remain available for 90 days.
Savara Inc. (SVRA) has reported its Q1 2025 financial results and provided significant business updates. The company completed the submission of a Biologics License Application (BLA) to the FDA for MOLBREEVI, targeting autoimmune PAP treatment, with a request for priority review. A potential PDUFA date is expected by year-end, with a U.S. launch planned for early 2026.
The company secured a non-dilutive debt financing of up to $200M in March, including $30M at close for refinancing existing debt. With ~$172.5M in cash and short-term investments as of March 31, 2025, Savara believes it is capitalized into 2H 2027. Q1 2025 resulted in a net loss of $26.6M ($0.12 per share), compared to $20.3M in Q1 2024. R&D expenses increased by 14% to $19.2M, while G&A expenses rose 64.1% to $9.2M.
The company plans to submit Marketing Authorization Applications for MOLBREEVI to both European and UK regulatory agencies by year-end.Savara Inc. (SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has announced its participation in the upcoming H.C. Wainwright & Co. 3rd Annual BioConnect Investor Conference. The company's management team will conduct one-on-one meetings and deliver a presentation on May 20, 2025, at 4:30 PM ET/1:30 PM PT. Investors and interested parties can access the live webcast and replay through the "Events & Presentations" section of Savara's corporate website, with the recording remaining available for 90 days.