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. (symbol: SVRA) is a specialty biopharmaceutical company that focuses on developing innovative therapies for rare respiratory diseases. The company’s principal approach centers on addressing serious and life-threatening pulmonary conditions. Its flagship product, AeroVanc, is the first-ever dry powder inhaled antibiotic specifically designed to treat methicillin-resistant Staphylococcus aureus (MRSA) infections in patients with cystic fibrosis (CF). This groundbreaking treatment aims to improve the quality of life and health outcomes for these patients.
Another significant project by Savara is the molgramostim nebulizer solution (molgramostim). This is an inhaled granulocyte-macrophage colony-stimulating factor currently in Phase 3 development for treating autoimmune pulmonary alveolar proteinosis (aPAP). aPAP is a rare and often debilitating lung disease with limited treatment options, and molgramostim seeks to fill this critical gap.
Savara's dedication to addressing unmet medical needs is evident through its focused development pipeline. The company operates as a single-segment entity specializing in respiratory system pharmaceuticals, highlighting its concentrated expertise and commitment to improving respiratory health.
In terms of financial health and partnerships, Savara has made strategic moves to secure funding and collaborations that bolster its research and development efforts. These partnerships and financial strategies are crucial for advancing its clinical programs and bringing innovative treatments to market.
For more detailed information on the company and its projects, please visit Savara’s official websites at www.savarapharma.com and www.aerovanc.com.
Savara Inc. (Nasdaq: SVRA) presented new data from the Phase 3 IMPALA-2 trial of molgramostim for autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the ERS Congress 2024. The trial met its primary endpoint, showing significant improvement in DLCO% at Week 24, sustained through Week 48. New results demonstrated:
1. Significant improvement in Disease Severity Score at Weeks 24 and 48
2. Higher proportions of DLCO% responders compared to placebo
3. Improved SGRQ Total Score responder analysis results
4. Significant improvement in Ground Glass Opacification Score at Week 24
Molgramostim was well-tolerated with a favorable benefit/risk profile. Savara plans to complete the BLA submission in the first half of 2025.
Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, has announced the grant of inducement awards to a new employee. The Compensation Committee of Savara's Board of Directors granted these awards on September 5, 2024, consisting of:
- Options to purchase 20,000 shares of the Company's common stock
- Restricted stock units (RSUs) covering 20,000 shares of the Company's common stock
The options have an exercise price of $4.54 per share, a 10-year term, and vest quarterly over 4 years. The RSUs vest in full after two years. These equity awards were granted under the Savara Inc. 2021 Inducement Equity Incentive Plan.
Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focusing on rare respiratory diseases, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The company's management team is scheduled to present on September 10, 2024, at 10:00 AM ET / 7:00 AM PT.
Investors and interested parties can access a live webcast of the presentation through Savara's official website at www.savarapharma.com/investors/events-presentations/. The webcast will remain archived for 90 days after the event, allowing those unable to attend the live presentation to review the content later.
Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focusing on rare respiratory diseases, has announced inducement awards for a new employee. The Compensation Committee granted these awards on August 15, 2024, consisting of:
1. Options to purchase 20,000 shares of common stock
2. Restricted stock units (RSUs) covering 20,000 shares of common stock
These equity awards were granted under the Savara Inc. 2021 Inducement Equity Incentive Plan. The options have an exercise price of $4.51 per share, vesting quarterly over four years. The RSUs vest fully after two years, subject to continued employment.
Savara Inc. (Nasdaq: SVRA) announced the acceptance of an abstract for poster presentation at the European Respiratory Society (ERS) Congress 2024, taking place September 7-11, 2024, in Vienna, Austria. The abstract, titled "Inhaled Molgramostim Improves Pulmonary Gas Exchange and Respiratory Health-Related Quality of Life (HRQoL) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results from IMPALA-2", will be presented on September 8, 2024.
Additionally, Savara is sponsoring an Industry Symposium titled "Pulmonary Alveolar Proteinosis: Pathophysiology, Diagnosis, and Management" on the same day. The symposium will feature speakers Cormac McCarthy, Elisabeth Bendstrup, and Francesco Bonella, all holding M.D. and Ph.D. degrees.
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.
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