Savara Inc Stock Price, News & Analysis

Savara (SVRA) received a Refusal to File (RTF) letter from the FDA regarding their Biologics License Application (BLA) for MOLBREEVI, a treatment for autoimmune Pulmonary Alveolar Proteinosis (PAP). The FDA determined the March 2025 BLA submission was incomplete, requesting additional Chemistry, Manufacturing, and Controls (CMC) data. Importantly, the RTF was not due to safety concerns, and no additional efficacy studies were requested. Savara plans to request a Type A meeting with the FDA within 30 days and expects to resubmit the BLA in Q4 2025. The company is progressing with establishing a redundant supply chain and has completed three upstream process performance qualification batches. MOLBREEVI maintains its Fast Track, Breakthrough Therapy, Orphan Drug, Innovation Passport, and Promising Innovative Medicine designations.

Savara (SVRA) has granted inducement awards to five new employees as part of their employment compensation package. The awards include: • Stock options to purchase 85,000 shares with an exercise price of $2.91 per share • Restricted stock units (RSUs) covering 75,000 shares The options have a 10-year term and vest quarterly (1/16th each quarter), while the RSUs vest fully after two years. These equity awards were granted under Savara's 2021 Inducement Equity Incentive Plan, complying with NASDAQ Rule 5635(c)(4).

Savara Inc. (SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has announced its participation in the upcoming Jefferies Global Healthcare Conference. The company's management team will conduct one-on-one meetings and deliver a presentation on June 4, 2025, at 9:20 AM ET. Investors can access the live webcast and replay of the presentation through the "Events & Presentations" section of Savara's corporate website, where it will remain available for 90 days.

Savara (SVRA) presented new data from its Phase 3 IMPALA-2 trial of molgramostim for autoimmune Pulmonary Alveolar Proteinosis (aPAP) at ATS 2025. The results showed that molgramostim significantly reduced surfactant burden with a mean reduction in GGO score of -2.1 vs. -1.1 for placebo (P=0.0004). Only 7.4% of molgramostim patients required rescue whole lung lavages compared to 13.3% in the placebo group. The drug also demonstrated significant improvements in health-related quality of life measures, including better SGRQ Impact scores (P=0.0084), reduced severity of breathing problems at Week 24 (P=0.0305) and Week 48 (P=0.0049), and improved daily physical activity levels at Week 24 (P=0.0368) and Week 48 (P=0.0193).

Savara Inc. (SVRA) has reported its Q1 2025 financial results and provided significant business updates. The company completed the submission of a Biologics License Application (BLA) to the FDA for MOLBREEVI, targeting autoimmune PAP treatment, with a request for priority review. A potential PDUFA date is expected by year-end, with a U.S. launch planned for early 2026.

The company secured a non-dilutive debt financing of up to $200M in March, including $30M at close for refinancing existing debt. With ~$172.5M in cash and short-term investments as of March 31, 2025, Savara believes it is capitalized into 2H 2027. Q1 2025 resulted in a net loss of $26.6M ($0.12 per share), compared to $20.3M in Q1 2024. R&D expenses increased by 14% to $19.2M, while G&A expenses rose 64.1% to $9.2M.

The company plans to submit Marketing Authorization Applications for MOLBREEVI to both European and UK regulatory agencies by year-end.

Savara Inc. (SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has announced its participation in the upcoming H.C. Wainwright & Co. 3rd Annual BioConnect Investor Conference. The company's management team will conduct one-on-one meetings and deliver a presentation on May 20, 2025, at 4:30 PM ET/1:30 PM PT. Investors and interested parties can access the live webcast and replay through the "Events & Presentations" section of Savara's corporate website, with the recording remaining available for 90 days.

Savara Inc. (SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, has announced its upcoming participation in the Citizens Life Sciences Conference. The company's management team will conduct one-on-one meetings and participate in a fireside chat on Thursday, May 8, 2025 at 10:30am EST/7:30am PST. The event will be accessible via live webcast and will remain available for replay on Savara's corporate website for 90 days.

Savara Inc. (Nasdaq: SVRA) has granted inducement awards to seven new employees as of April 9, 2025. The awards include stock options for 107,000 shares and restricted stock units (RSUs) covering 83,000 shares, granted under the company's 2021 Inducement Equity Incentive Plan.

The stock options have an exercise price of $2.74 per share, matching the closing price on NASDAQ Global Market on the grant date. These options have a 10-year term and vest quarterly at 1/16th of the shares. The RSUs will fully vest after two years, contingent on continued employment.

Savara Inc. (Nasdaq: SVRA) has announced upcoming encore presentations of top-line data from their pivotal Phase 3 IMPALA-2 clinical trial of molgramostim inhalation solution for treating autoimmune Pulmonary Alveolar Proteinosis (aPAP). The presentations will be featured at two major scientific conferences:

1. The 65th Congress of the German Society of Pneumology (DGP) in Leipzig, Germany (April 9-12, 2025), where Dr. Francesco Bonella will present findings showing molgramostim's improvements in pulmonary gas exchange, quality of life, and exercise capacity in aPAP patients.

2. The 65th Annual Meeting of the Japanese Respiratory Society (JRS) in Tokyo, Japan (April 11-13, 2025), where Dr. Yoshikazu Inoue will present the IMPALA-2 Phase 3 trial results.

The presentations will subsequently be made available on Savara's corporate website under the Congresses & Publications section.