Savara Inc - SVRA STOCK NEWS

Savara Inc. (Nasdaq: SVRA) announced that a new episode of The Balancing Act® on Lifetime TV's Behind the Mystery™ series is featuring autoimmune Pulmonary Alveolar Proteinosis (aPAP). The episode, sponsored by Savara, focuses on an aPAP patient's diagnostic journey and includes insights from Dr. Bruce Trapnell, the International Coordinating Investigator for Savara's IMPALA-2 Phase 3 clinical trial of molgramostim inhalation solution in aPAP.

The episode aims to educate viewers about aPAP's symptoms and diagnosis, highlighting the lack of approved treatments in the US and Europe. Savara's CEO, Matt Pauls, emphasized the company's commitment to the aPAP community and their goal of providing an effective therapy. Savara expects to complete submission of the Biologics License Application (BLA) for molgramostim in aPAP with the FDA in the first half of 2025.

Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focusing on rare respiratory diseases, has announced the grant of inducement awards to four new employees. The Compensation Committee of Savara's Board of Directors granted these awards on October 17, 2024, consisting of:

• Options to purchase 95,000 shares of common stock
• Restricted stock units (RSUs) covering 95,000 shares of common stock

These equity awards were granted under the Savara Inc. 2021 Inducement Equity Incentive Plan, in compliance with NASDAQ Listing Rules. The options have an exercise price of $3.65 per share, a 10-year term, and vest quarterly over four years. The RSUs vest in full after two years, subject to continued employment.

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.