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. (SVRA) is a clinical-stage biopharmaceutical company pioneering inhaled therapies for rare respiratory diseases. This page serves as the definitive source for official announcements, clinical trial updates, and regulatory developments related to their innovative pipeline targeting conditions like cystic fibrosis and autoimmune pulmonary alveolar proteinosis.
Investors and healthcare professionals will find timely updates on Phase 3 clinical trials, FDA regulatory milestones, and strategic partnerships in respiratory drug development. Our curated news collection provides essential context about SVRA's novel dry powder antibiotics and nebulized biologic therapies while maintaining strict compliance with financial disclosure standards.
Key updates include progress reports on Aerovanc™ for MRSA lung infections, molgramostim nebulizer solution developments, and analyses of market positioning within rare disease therapeutics. All content is verified through primary sources to ensure accuracy for investment research and medical community reference.
Bookmark this page for consolidated access to Savara's latest corporate announcements, peer-reviewed research collaborations, and therapeutic advancement timelines. Check regularly for objective updates on breakthrough inhalation technologies addressing critical needs in pulmonary medicine.
Savara Inc. (Nasdaq: SVRA) has announced the Savara Early Access Program, an Expanded Access Program (EAP) for molgramostim inhalation solution to treat patients with autoimmune pulmonary alveolar proteinosis (aPAP). This program allows physicians to request molgramostim for eligible aPAP patients in select regions where the product is not commercially available, in compliance with local regulations.
The EAP has been approved by the U.S. Food and Drug Administration (FDA) and is currently accepting requests from eligible patients in select North American and European countries, with plans to expand through 2026. Savara plans to submit a Biologics License Application to the FDA for molgramostim in aPAP in the first half of 2025.
Molgramostim has received Orphan Drug, Fast Track, and Breakthrough Therapy designations from the FDA, as well as similar designations from European and UK regulatory agencies for the treatment of aPAP.
Savara Inc. (Nasdaq: SVRA) has appointed Braden Parker as Chief Commercial Officer, effective immediately. Parker brings over 25 years of commercial leadership experience in healthcare and biotech, with expertise in launching rare disease products. He will oversee Savara's global commercial strategy for molgramostim inhalation solution in autoimmune Pulmonary Alveolar Proteinosis (aPAP).
Parker joins from Orchard Therapeutics, where he served as Chief Commercial Officer. His previous roles include Vice President and General Manager at PTC Therapeutics and commercial leadership positions at Celgene and NPS Pharma. Savara plans to complete submission of a Biologics License Application (BLA) for molgramostim to the FDA in the first half of 2025. If approved, it would be the first treatment for aPAP in the U.S. and Europe.
Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focusing on rare respiratory diseases, will host an analyst and investor webinar on September 30, 2024 from 8:30-9:30 a.m. ET. The webinar will present data from the Phase 3 IMPALA-2 clinical trial of molgramostim inhalation solution in autoimmune Pulmonary Alveolar Proteinosis (aPAP). It will also provide updates on the global commercial landscape and the Company's market development work.
The webinar will feature presentations from Savara's management team and key opinion leaders, including Dr. Ali Ataya from the University of Florida and Dr. Bruce Trapnell from the University of Cincinnati College of Medicine. Interested parties can access the webinar with slides via a provided link or through Savara's website. A phone-in option is also available through registration. A replay of the webinar will be accessible approximately 24 hours after the call and archived for 90 days on the company's website.
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.
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