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, a clinical-stage biopharmaceutical company focused on rare respiratory diseases, announced the acceptance of an abstract for poster presentation at the CHEST 2024 Annual Meeting, scheduled for October 6-9 in Boston. The abstract, titled “A Patient Journey Map for People Living with Autoimmune Pulmonary Alveolar Proteinosis (aPAP),” will be featured in the Diffuse Lung Disease Abstracts Posters (D) session on October 8, 2024, from 1:45 to 2:30pm EDT. Additionally, Savara is sponsoring an Industry Symposium at the meeting, titled “Pulmonary Alveolar Proteinosis: Pathophysiology, Diagnosis, and Management,” which will take place on October 8, 2024, from 2:00 to 2:45pm EDT at the CHEST Learning Theater. The symposium will be led by Dr. Ali Ataya, Associate Professor of Medicine at the University of Florida, Division of Pulmonary and Critical Care Medicine.
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. On September 25, 2024, the company's Board of Directors granted inducement awards to Braden Parker, who joined as Chief Commercial Officer on September 24, 2024.
The inducement awards include:
- Options to purchase 170,000 shares of common stock
- Restricted stock units (RSUs) covering 85,000 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 $4.15 per share, a 10-year term, and vest quarterly over 4 years. The RSUs vest in full on the two-year anniversary of employment, subject to continued employment.
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.
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