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. (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.
Savara Inc. (SVRA) has secured a non-dilutive debt financing agreement with Hercules Capital for up to $200 million. The initial $30 million will refinance existing debt, with an additional $100 million available upon FDA approval of MOLBREEVI and certain milestones. The remaining $70 million can be accessed at Hercules' discretion.
The five-year loan agreement features a 36-month interest-only period, extendable to 60 months upon FDA approval of MOLBREEVI. This financing follows Savara's Biologics License Application submission to the FDA for MOLBREEVI, a potential first-in-class therapy for autoimmune pulmonary alveolar proteinosis (aPAP). With Priority Review, approval could come by year-end, coinciding with planned European Marketing Authorization Application submission.
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, which could reduce FDA review time from ten to six months.
The IMPALA-2 trial demonstrated statistically significant improvements in lung function, meeting its primary endpoint of improved pulmonary gas exchange (DLCO) at Week 24, with sustained benefits through Week 48. The treatment showed clinical benefits in respiratory quality (SGRQ scores) and exercise capacity (METs), with a strong safety profile as 97% of patients completed the trial.
MOLBREEVI has received multiple regulatory designations, including Fast Track, Breakthrough Therapy, and Orphan Drug status. Savara plans to submit a Marketing Authorization Application in Europe by end-2025, with a potential U.S. commercial launch in early 2026.
Savara Inc. (SVRA) announced the acceptance of two posters for presentation at the American Thoracic Society (ATS) International Conference in May 2025. The presentations will showcase new data from the Phase 3 IMPALA-2 trial of Molgramostim inhalation solution for treating autoimmune Pulmonary Alveolar Proteinosis (aPAP).
The first poster will present results showing how Molgramostim reduces surfactant burden and whole lung lavage procedures in aPAP patients. The second poster will discuss the treatment's effects on respiratory health-related quality of life and patient-reported outcomes. Both abstracts will be published in the American Journal of Respiratory and Critical Care Medicine.
Additionally, Savara will host an Industry Theater session titled 'Advances in Autoimmune Pulmonary Alveolar Proteinosis' featuring experts Dr. Bruce Trapnell and Dr. Cormac McCarthy, who will discuss aPAP's pathophysiology, symptoms, diagnosis, and management.
Savara Inc. (SVRA) has launched the aPAP ClearPath™ Dried Blood Spot (DBS) Test in the U.S., advancing their diagnostic capabilities for autoimmune pulmonary alveolar proteinosis (aPAP). This new test requires only a finger-prick blood sample and has demonstrated 100% analytical sensitivity and specificity in detecting GM-CSF autoantibodies.
Developed in partnership with TrilliumBiO's CLIA-certified lab, the test is offered at no cost and provides a convenient alternative to traditional venous blood draws. The company is currently finalizing its rolling BLA submission for MOLBREEVI™, their potential first-ever FDA-approved aPAP treatment, targeted for completion by the end of Q1 2025.
aPAP is a rare lung disease where antibodies neutralize GM-CSF, preventing proper surfactant clearance in the lungs, leading to breathing difficulties and potential serious complications including lung fibrosis.
Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has announced its upcoming participation in the Leerink Global Healthcare Conference. The company's management team will engage in a fireside chat scheduled for Tuesday, March 11th at 10:40am ET/7:40am PT.
The event will be accessible through a live webcast and will remain available for replay on Savara's corporate website under the 'Events & Presentations' section for 90 days following the presentation.
Savara Inc. (SVRA) has granted inducement awards to five new employees, as announced by the company's Compensation Committee on February 12, 2025. The awards include:
- Stock options to purchase 97,500 shares with an exercise price of $2.75 per share, vesting quarterly over four years (1/16th per quarter)
- Restricted stock units (RSUs) covering 82,500 shares, vesting fully after two years
These equity awards were granted under Savara's 2021 Inducement Equity Incentive Plan, complying with NASDAQ Listing Rule 5635(c)(4). The stock options have a 10-year term, and both options and RSUs are subject to continued employment through their respective vesting dates.
Savara Inc. (SVRA) announced the publication of a manuscript in ERJ Open Research detailing long-term outcomes of molgramostim inhalation solution in treating autoimmune pulmonary alveolar proteinosis (aPAP). The retrospective study evaluated five aPAP patients who received molgramostim through European single-patient access over a mean duration of 4.2 years.
The study demonstrated significant improvements including enhanced lung function, decreased disease burden, and reduced clinical symptoms. Key findings showed improvements in pulmonary gas transfer and activities of daily living. Notably, while four patients required whole lung lavage (WLL) before treatment, none needed it after one year of molgramostim use. The treatment was well-tolerated with no serious adverse events reported.
Savara plans to complete its rolling Biologics License Application (BLA) submission in the U.S. by the end of Q1 2025 and submit a Marketing Authorization Application (MAA) in Europe by the end of 2025.
Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has announced its participation in two major healthcare investor conferences in February 2025.
The company's management team will participate in fireside chats at both events:
- The Guggenheim SMID Cap Biotech Conference (February 5-6, 2025), with a fireside chat scheduled for February 5th at 10:00am ET/7:00am PT
- The Oppenheimer 35th Annual Healthcare Life Sciences Conference (February 11-12, 2025), with a fireside chat scheduled for February 11th at 8:00am ET/5:00am PT
Live webcasts and replays will be accessible through Savara's corporate website in the 'Events & Presentations' section, remaining available for 90 days.
FAQ
What is the current stock price of Savara (SVRA)?
What is the market cap of Savara (SVRA)?
