Savara Inc. (NASDAQ:SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced that the Company received an RTF letter from the FDA for the BLA of MOLBREEVI as a therapy to treat patients with autoimmune PAP. Upon preliminary review, the FDA determined that the BLA submitted in March 2025 was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls (CMC). The RTF was not the result of safety concerns, and the FDA did not request or recommend additional efficacy studies. Within the next 30 days, the Company intends to request a Type A meeting with the Age

Savara Inc. (NASDAQ:SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the grant of inducement awards to five new employees. On May 21, 2025, the Compensation Committee of Savara's Board of Directors granted the inducement awards to five new employees who recently joined the Company. The inducement awards consist of options to purchase an aggregate of 85,000 shares of the Company's common stock and restricted stock units (RSUs) covering an aggregate of 75,000 shares of the Company's common stock. These equity awards were granted under the Savara Inc. 2021 Inducement Equity Incentive Plan pursuant to Rule 5635(c)(4) of the NASDAQ Listing

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced members of the management team will host 1x1 meetings and present at the Jefferies Global Healthcare Conference on June 4, 2025, at 9:20am ET/6:20am PT. The live webcast and subsequent replay will be available on the "Events & Presentations" section of the Company's corporate website and will be archived for 90 days. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development

Savara Inc. (NASDAQ:SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced new data in two poster presentations at the ATS International Conference 2025. Data presented were from the Phase 3 IMPALA-2 clinical trial of molgramostim in aPAP and demonstrated that molgramostim reduces surfactant burden and improves health-related quality of life outcomes in patients with aPAP. ATS 2025 Posters Poster Title: Molgramostim Reduces Surfactant Burden and Number of Whole Lung Lavage Procedures in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP): Results From the IMPALA-2 Phase 3 Clinical Trial Presenter: Tisha S. Wang, M.D

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced members of the management team will host 1x1 meetings and present at the H.C. Wainwright & Co. 3rd Annual BioConnect Investor Conference on May 20, 2025, at 4:30pm ET/1:30pm PT. The live webcast and subsequent replay will be available on the "Events & Presentations" section of the Company's corporate website and will be archived for 90 days. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF

Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that members of the management team will be hosting 1x1 meetings and participating in a fireside chat at the Citizens Life Sciences Conference on Thursday, May 8, 2025 at 10:30am EST/7:30am PST. The live webcast and subsequent replay will be available on the "Events & Presentations" section of the Company's corporate website at https://savarapharma.com/investors/events-presentations/ and will be archived for 90 days. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is

Savara Inc. (NASDAQ:SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the grant of inducement awards to seven new employees. On April 9, 2025, the Compensation Committee of Savara's Board of Directors granted the inducement awards to seven new employees who recently joined the Company. The inducement awards consist of options to purchase an aggregate of 107,000 shares of the Company's common stock and restricted stock units (RSUs) covering an aggregate of 83,000 shares of the Company's common stock. These equity awards were granted under the Savara Inc. 2021 Inducement Equity Incentive Plan pursuant to Rule 5635(c)(4) of the NASDAQ List

Savara Inc. (NASDAQ:SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, announced encore presentations of top-line data from the pivotal, Phase 3 IMPALA-2 clinical trial of molgramostim in aPAP will be presented at the 65th Congress of the German Society of Pneumology (DGP) in Leipzig, Germany taking place April 9-12 and at the 65th Annual Meeting of the Japanese Respiratory Society (JRS) taking place April 11-13, 2025, in Tokyo, Japan. DGP 2025 Virtual Presentation Poster Title: Inhaled Molgramostim Improves Pulmonary Gas Exchange, Quality of Life, and Exercise Capacity in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Ses

-- Completed Submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* as a Treatment for Autoimmune Pulmonary Alveolar Proteinosis (aPAP) -- -- Priority Review Was Requested, Commercial Launch Preparations Underway -- -- With ~$196M in Cash and Short-Term Investments as of December 31, 2024, the Company Believes it is Sufficiently Capitalized through 2Q 2027, Excluding the Recent Debt Financing of Up To $200M -- Savara Inc. (NASDAQ:SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported financial results for the fourth quarter and full year ending December 31, 2024 and provid

Includes $30M at Close to Refinance Existing Debt Facility Savara Inc. (NASDAQ:SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that it has entered into a loan and security agreement with Hercules Capital, Inc. (NYSE:HTGC), for up to $200 million. Access to the additional capital strengthens Savara's balance sheet following the submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* as a treatment for autoimmune pulmonary alveolar proteinosis (aPAP). If Priority Review is granted by the FDA, MOLBREEVI could potentially be approved by the end of the year. The Comp

4 - Savara Inc (0001160308) (Issuer)

4 - Savara Inc (0001160308) (Issuer)

4 - Savara Inc (0001160308) (Issuer)

4 - Savara Inc (0001160308) (Issuer)

Statistically Significant Improvement in Percent Predicted Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Versus Placebo at Week 24 (Primary Endpoint) and Week 48 (Secondary Endpoint) Statistically Significant Improvement in St. George's Respiratory Questionnaire (SGRQ) Total Score at Week 24 (Secondary Endpoint) 97% of Patients Completed Double-Blind Treatment Through Week 48 with No Trial Drug Related Adverse Events Leading to Discontinuation 100% of Patients Completing the 48-Week Double-Blind Period Elected to Participate in the 96-Week Open-Label Period Company Plans to Complete BLA Submission in 1H 2025 Company to Host Webcast Conference Call Today, Ju

Conference Call to Take Place Tomorrow, Wednesday, June 26, 2024, at 8:00am ET Savara Inc. (NASDAQ:SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that it will host a conference call and webcast tomorrow, Wednesday, June 26, 2024, at 8:00am ET to discuss top line results from the pivotal, Phase 3 IMPALA-2 clinical trial assessing the efficacy and safety of molgramostim, an inhaled form of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in patients with aPAP. The Company plans to issue a press release sharing the top line results at approximately 6:30am ET tomorrow, prior to the start of the c