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) reported positive top-line results from the IMPALA-2 Phase 3 trial of molgramostim for treating autoimmune pulmonary alveolar proteinosis (aPAP). The trial met its primary endpoint, showing statistically significant improvement in lung diffusing capacity at 24 weeks. Key secondary endpoints were also met, including improvements in respiratory quality of life.
The FDA conditionally accepted the trade name MOLBREEVI™ for molgramostim. Savara plans to complete the BLA submission in H1 2025. The company raised ~$100M in equity financing in July 2024, bringing its total cash position to over $200M, expected to fund operations through 2026.
For Q2 2024, Savara reported a net loss of $22.2M, or $(0.12) per share. R&D expenses increased 97.7% YoY to $17.6M, while G&A expenses rose 67.8% to $5.5M.
Savara, a clinical-stage biopharmaceutical company focused on rare respiratory diseases, has announced the pricing of an underwritten offering of 26,246,720 shares of its common stock at $3.81 per share. This offering aims to raise approximately $100.0 million before deducting underwriting discounts and commissions. The offering involves notable investors such as Bain Capital Life Sciences and Wellington Management and is expected to close on July 1, 2024, subject to customary conditions. Jefferies, Piper Sandler, and Guggenheim Securities are the joint book-running managers, with Oppenheimer & Co. as the lead manager. The offering is conducted under Savara's existing shelf registration statement filed with the SEC. Detailed prospectus information can be obtained from the involved financial institutions or the SEC website.
Savara announced positive results from its pivotal Phase 3 IMPALA-2 trial of molgramostim for autoimmune pulmonary alveolar proteinosis (aPAP). Molgramostim showed statistically significant improvements in lung function (DLCO) versus placebo at both Week 24 and Week 48. Additionally, improvements were seen in St. George’s Respiratory Questionnaire (SGRQ) scores at Week 24. Notably, 97% of patients completed the 48-week double-blind treatment with no trial drug-related discontinuations. The company plans to complete the Biologics License Application submission by the first half of 2025. Molgramostim was well tolerated with similar adverse event frequencies between treatment groups. Savara will host a webcast conference call to discuss these results.
Savara, a clinical-stage biopharmaceutical company specializing in rare respiratory diseases, will host a conference call and webcast on June 26, 2024, at 8:00am ET to discuss the top line results from its pivotal Phase 3 IMPALA-2 trial. This trial assesses the safety and efficacy of molgramostim, an inhaled GM-CSF, in treating autoimmune pulmonary alveolar proteinosis (aPAP). A press release detailing these results will be issued at 6:30am ET on the same day, prior to the call. Stakeholders can access the live webcast through Savara's website or by phone registration, with a replay available for 90 days.
Savara, a clinical stage biopharmaceutical company focusing on rare respiratory diseases, announced its participation in the Jefferies Global Healthcare Conference. The management team will engage in a fireside chat scheduled for June 5, 2024, at 7:00am PT/10:00am ET. The event will be live-streamed on Savara's website and will remain accessible for 90 days. This conference is a significant platform for industry exposure, potentially impacting SVRA stock performance.
Savara (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, presented significant data at the American Thoracic Society (ATS) 2024 International Conference. The event, taking place from May 17-22, 2024, in San Diego, CA, featured two important posters.
Poster Board 701, sponsored by Savara, detailed a cohort study revealing that pulmonary alveolar proteinosis (PAP) patients face a substantial healthcare burden. This includes a 4-fold increase in hospital admissions and costs compared to non-PAP controls.
Poster Board 702, presented by Trillium Health , showcased a novel laboratory test for diagnosing autoimmune pulmonary alveolar proteinosis (aPAP) with 100% clinical accuracy. This test detects GM-CSF antibodies in human serum, offering a precise and sensitive diagnostic tool.
Savara has announced inducement awards for a new employee hired on May 14, 2024. The awards include options to purchase 15,000 shares of common stock and 2,500 restricted stock units (RSUs). The options, priced at $4.81 per share, align with the closing trading price on the grant date and have a 10-year term. The options vest quarterly over four years, while the RSUs vest in full after two years. These grants are made under Savara's 2021 Inducement Equity Incentive Plan according to NASDAQ Rule 5635(c)(4).
Savara Inc. (Nasdaq: SVRA) reported their first-quarter financial results for 2024, showcasing a net loss of $20.3 million compared to $10.6 million in 2023. The company remains focused on the Phase 3 IMPALA-2 trial evaluating molgramostim for autoimmune Pulmonary Alveolar Proteinosis, with top-line results expected by 2Q 2024. Savara anticipates submitting a Biologics License Application in 1H 2025 and is well-capitalized with $143 million in cash into 2026.
Savara Inc. (SVRA) will be presenting at the Citizens JMP Life Sciences Conference, with a live webcast available on their website. The event is scheduled for May 14, 2024, at 6:00am PT/9:00am ET, focusing on rare respiratory diseases.
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