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 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.
Savara Inc. (SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has announced its upcoming participation in the Citizens Life Sciences Conference. The company's management team will conduct one-on-one meetings and participate in a fireside chat on Thursday, May 8, 2025 at 10:30am EST/7:30am PST. The event will be accessible via live webcast and will remain available for replay on Savara's corporate website for 90 days.
Savara Inc. (Nasdaq: SVRA) has granted inducement awards to seven new employees as of April 9, 2025. The awards include stock options for 107,000 shares and restricted stock units (RSUs) covering 83,000 shares, granted under the company's 2021 Inducement Equity Incentive Plan.
The stock options have an exercise price of $2.74 per share, matching the closing price on NASDAQ Global Market on the grant date. These options have a 10-year term and vest quarterly at 1/16th of the shares. The RSUs will fully vest after two years, contingent on continued employment.
Savara Inc. (Nasdaq: SVRA) has announced upcoming encore presentations of top-line data from their pivotal Phase 3 IMPALA-2 clinical trial of molgramostim inhalation solution for treating autoimmune Pulmonary Alveolar Proteinosis (aPAP). The presentations will be featured at two major scientific conferences:
1. The 65th Congress of the German Society of Pneumology (DGP) in Leipzig, Germany (April 9-12, 2025), where Dr. Francesco Bonella will present findings showing molgramostim's improvements in pulmonary gas exchange, quality of life, and exercise capacity in aPAP patients.
2. The 65th Annual Meeting of the Japanese Respiratory Society (JRS) in Tokyo, Japan (April 11-13, 2025), where Dr. Yoshikazu Inoue will present the IMPALA-2 Phase 3 trial results.
The presentations will subsequently be made available on Savara's corporate website under the Congresses & Publications section.
Savara Inc. (SVRA) has completed the submission of its Biologics License Application (BLA) to the FDA for MOLBREEVI, a potential first-ever treatment for autoimmune Pulmonary Alveolar Proteinosis (aPAP). The company has requested Priority Review and expects a possible PDUFA date by year-end, targeting early 2026 for commercial launch.
Financial highlights for Q4 2024 include a net loss of $29.0 million ($0.13 per share), with R&D expenses of $23.3 million and G&A expenses of $7.8 million. For full-year 2024, net loss was $95.9 million ($0.48 per share), with R&D expenses increasing 76.3% to $78.0 million and G&A expenses rising 59.8% to $25.0 million.
The company maintains a strong financial position with $196.3 million in cash and short-term investments as of December 31, 2024, providing runway through Q2 2027, excluding an additional debt financing of up to $200 million.