-- 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

-- Priority Review Was Requested, Commercial Launch Preparations Underway -- -- MOLBREEVI Has the Potential to Be the First and Only Approved Therapy for aPAP in the U.S. and Europe -- -- Company Remains on Track to Submit the Marketing Authorization Application (MAA) in Europe by the End of 2025 -- Savara Inc. (NASDAQ:SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that it has completed submission of the BLA to the FDA for MOLBREEVI as a treatment for aPAP. "Submission of the BLA marks an important milestone for the Company and the aPAP community," said Matt Pauls, Chair and Chief Executive Officer, Savara. "We belie

Wells Fargo initiated coverage of Savara with a rating of Overweight and set a new price target of $8.00

Evercore ISI downgraded Savara from Outperform to In-line and set a new price target of $5.00 from $7.00 previously

JMP Securities initiated coverage of Savara with a rating of Mkt Outperform and set a new price target of $8.00

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4 - Savara Inc (0001160308) (Issuer)

4 - Savara Inc (0001160308) (Issuer)

4 - Savara Inc (0001160308) (Issuer)

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4 - Savara Inc (0001160308) (Issuer)

8-K - Savara Inc (0001160308) (Filer)

10-K - Savara Inc (0001160308) (Filer)

8-K - Savara Inc (0001160308) (Filer)

Mr. Parker has More Than 25 Years of Commercial Leadership Experience and has Launched Multiple Rare Disease Products Savara Inc. (NASDAQ:SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the appointment of Braden Parker as Chief Commercial Officer, effective immediately. Mr. Parker is a seasoned global commercial leader with more than 25 years of experience in the healthcare and biotech industry. Throughout his career, he has developed and executed global commercial plans, including market expansion activities, built high-performance teams, and launched multiple successful rare disease products. Mr. Parker is responsible

 Pivotal Phase 3 IMPALA-2 Trial Remains On-Track, Top Line Data Expected End of 2Q 2024 IMPALA-2 is evaluating molgramostim nebulizer solution (molgramostim), a novel inhaled biologic, for the treatment of autoimmune Pulmonary Alveolar Proteinosis (aPAP), a rare lung disease Received Acceptance from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) on a Revised Pediatric Investigation Plan (PIP) for Molgramostim in aPAP Appoints Raymond Pratt, M.D., Chief Medical Officer Company Ends Quarter with ~$134M, Believes it is Sufficiently Capitalized Through 2025 Savara Inc. (NASDAQ:SVRA), a clinical stage biopharmaceutical company focused on rare respiratory disease

Savara Inc. (NASDAQ:SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that Badrul Chowdhury, M.D., Ph.D., has resigned from his role as Chief Medical Officer, effective September 9, 2022. "We appreciate Dr. Chowdhury's contributions during his tenure with the company," said Matt Pauls, Chair and CEO, Savara. "His leadership helped progress our molgramostim nebulizer solution (molgramostim) development program through some important milestones and we wish him well in the future." "I am pleased to have been part of the Savara team and wish the company success in the continued development of molgramostim for the treatment of the rare lung

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

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