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) priced an underwritten public offering on October 30, 2025 of 23,809,524 shares of common stock at $4.20 per share and, in lieu of common stock to certain investors, 7,142,857 pre-funded warrants at $4.199 each, for total gross proceeds of $130.0 million. The company also granted a 30-day underwriter option to purchase up to 4,642,857 additional shares.
The offering is expected to close on October 31, 2025, subject to customary conditions. Proceeds are intended for general corporate purposes, including funding clinical development and regulatory approval for MOLBREEVI, commercialization infrastructure and supply, U.S. and EU commercial launch preparation, and general and administrative expenses.
Savara (Nasdaq: SVRA) announced a proposed underwritten public offering of shares of common stock and, for certain investors, pre-funded warrants on October 29, 2025. The offering is subject to market and other conditions and may not be completed.
Savara said it intends to use proceeds for general corporate purposes, including funding clinical development and regulatory approval efforts for MOLBREEVI, investing in commercialization infrastructure and supply, U.S. and EU commercial launch preparation, and general and administrative expenses. Underwriters have a 30-day option to purchase up to an additional 15% of the offered shares and pre-funded warrants. Jefferies, Piper Sandler, and Guggenheim are joint book-running managers.
Savara (NASDAQ: SVRA) announced a $75 million royalty funding agreement with RTW Investments to support a potential U.S. launch of MOLBREEVI for autoimmune pulmonary alveolar proteinosis (autoimmune PAP), contingent on FDA approval and customary closing conditions.
The financing is non-dilutive, becomes available upon approval, and pays RTW a tiered single‑digit percentage of U.S. annual net sales for MOLBREEVI subject to a cap. Savara plans to resubmit the MOLBREEVI BLA in December 2025 and cites pivotal IMPALA-2 results as supporting commercial potential.
Savara (NASDAQ: SVRA) announced a management change on October 17, 2025: Yasmine Wasfi, M.D., Ph.D., FCCP has been promoted to Chief Medical Officer, effective immediately, and will report to the company’s Chair and CEO. Ray Pratt, M.D., FACP will transition from CMO to Senior Medical Advisor while remaining involved with the MOLBREEVI program. The release highlights Dr. Wasfi’s two decades of respiratory and immunology experience and Dr. Pratt’s 35 years in drug development. The company frames the moves as continuity for advancing the MOLBREEVI clinical program toward U.S. and European market access.
Savara (Nasdaq: SVRA) announced encore presentations of Phase 3 IMPALA-2 clinical trial results at CHEST 2025 in Chicago, October 19-22, 2025.
The program includes an oral rapid‑fire presentation on Oct 21, 2025, 10:56–11:00 AM CDT (Session ID 4053) covering efficacy of inhaled molgramostim by aPAP severity, a poster on pulmonary gas transfer and HRQoL on Oct 22 (Poster 4260), and a TrilliumBiO poster (Poster 4257) on a dried serum assay to detect GM‑CSF antibodies for aPAP diagnosis. Savara will also host a Learning Theatre on Oct 21, 12:30–1:15 PM CDT. Posters and slides will be posted on Savara's Congresses & Publications webpage after the meeting.
Savara (NASDAQ:SVRA) presented new analyses from its Phase 3 IMPALA-2 clinical trial of molgramostim for autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the ERS Congress 2025. The data showed that molgramostim demonstrated significant improvements in pulmonary gas transfer (DLco%), quality of life, and patient functionality regardless of disease severity.
Key findings revealed that changes in DLco% (the primary endpoint) significantly correlated with improvements in respiratory health-related quality of life, patient functionality, and reduced surfactant burden. Additionally, Savara's partner TrilliumBiO presented data on a new dried blood spot test showing high precision and sensitivity for detecting GM-CSF autoantibodies, potentially advancing aPAP diagnosis.
[ "Molgramostim showed efficacy across all disease severity levels", "Significant improvements in multiple clinical measures including pulmonary gas transfer and quality of life", "Development of new diagnostic tool with high precision for aPAP detection", "Strong correlation between primary endpoint (DLco%) and clinical outcomes" ]Savara (Nasdaq: SVRA) has announced a significant update in the estimated U.S. patient population for autoimmune Pulmonary Alveolar Proteinosis (PAP). A new health claims data analysis reveals approximately 5,500 autoimmune PAP patients in the U.S., representing a 50% increase from the previous estimate of ~3,600 patients in 2023.
The company is preparing to resubmit its Biologics License Application (BLA) for MOLBREEVI in December 2025, with plans to request priority review. The drug candidate has received multiple regulatory designations, including Fast Track and Breakthrough Therapy from the FDA. Recently, the New England Journal of Medicine published results from Savara's pivotal Phase 3 IMPALA-2 clinical trial of MOLBREEVI in autoimmune PAP.
Savara (Nasdaq: SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has announced its participation in two major healthcare investor conferences. The management team will conduct one-on-one meetings and deliver presentations at the Wells Fargo Securities Healthcare Conference on September 3, 2025, at 4:30 PM ET and the H.C. Wainwright Global Healthcare Conference on September 9, 2025, at 1:00 PM ET.
Both presentations will be accessible via live webcast on Savara's corporate website under the "Events & Presentations" section, with recordings available for 90 days following the events.
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 (p<0.001), 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.
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