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Savara Inc. develops therapies for rare respiratory diseases, with a lead program in molgramostim inhalation solution, conditionally named MOLBREEVI, for autoimmune pulmonary alveolar proteinosis. Molgramostim is a recombinant human GM-CSF delivered through an investigational eFlow Nebulizer System developed for inhalation of the large-molecule therapy.
Recurring company developments include clinical data from the IMPALA-2 program, regulatory submissions and agency-review updates in the U.S., Europe and the U.K., financial results, financing arrangements, equity inducement grants and investor conference participation. Savara's updates also note that MOLBREEVI is not approved in any indication.
Savara Inc. (NASDAQ: SVRA), a clinical-stage biopharmaceutical company, announced the grant of inducement awards to three new employees on September 13, 2022. These awards include options for 190,000 shares and RSUs for 75,000 shares, part of the 2021 Inducement Equity Incentive Plan. The options have an exercise price of $1.46 per share and vest quarterly over 10 years. Savara focuses on rare respiratory diseases, with its lead program, molgramostim, in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP).
Savara Inc. (NASDAQ: SVRA) presented three posters at the ERS International Congress 2022 in Barcelona, focusing on autoimmune pulmonary alveolar proteinosis (aPAP). Key findings include a post hoc analysis from the IMPALA trial showing improved gas exchange and health status in patients treated with inhaled molgramostim compared to placebo. Safety data from the IMPALA-X study indicated no new safety signals. The company highlighted the rationale for using DLco as a primary endpoint in the ongoing IMPALA-2 trial, aiming to demonstrate the efficacy of molgramostim in aPAP.
Savara Inc. (NASDAQ: SVRA), a biopharmaceutical firm targeting rare respiratory diseases, announced that CEO Matt Pauls will present at the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. The presentation is scheduled for 7:00 AM ET/4:00 AM PT on September 12, 2022, and will be accessible via a webcast on Savara’s website, where it will remain archived for 90 days. Savara’s lead product, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP).
Savara Inc. (NASDAQ: SVRA) announced the resignation of Chief Medical Officer Badrul Chowdhury, effective September 9, 2022. The company expressed appreciation for his contributions, particularly in advancing the molgramostim nebulizer solution for autoimmune pulmonary alveolar proteinosis (aPAP). Chowdhury leaves with confidence in the ongoing Phase 3 IMPALA-2 trial. Savara focuses on rare respiratory diseases, with molgramostim being a key product in development, delivered via the investigational eFlow® Nebulizer System.
Savara Inc. (NASDAQ: SVRA) announced its molgramostim received Promising Innovative Medicine (PIM) designation from the UK’s MHRA for treating autoimmune pulmonary alveolar proteinosis (aPAP). This designation enhances molgramostim’s chance for early access under the UK’s Early Access to Medicines Scheme (EAMS), allowing potential patient use 12-18 months prior to formal marketing authorization. Previous recognitions include Fast Track and Breakthrough Therapy designations from the FDA.
Savara Inc. (Nasdaq: SVRA) reported its financial results for Q2 2022, noting a net loss of $9.2 million, or $(0.06) per share, an improvement from the previous year's loss of $10.9 million. Research and development expenses decreased by 11.5% to $6.4 million, attributed to timing in contract research costs. The pivotal Phase 3 IMPALA-2 trial of Molgramostim remains on track for top-line data by the end of Q2 2024. The company holds approximately $142 million in cash, indicating sufficient funding through 2025.
Savara Inc. (NASDAQ: SVRA), a clinical-stage biopharmaceutical company, announced the acceptance of three abstracts for poster presentation at the ERS International Congress 2022, taking place in Barcelona, Spain from September 4-6, 2022. The accepted abstracts focus on the efficacy measures in patients requiring lung lavage, safety of inhaled molgramostim for aPAP, and the choice of DLCO as a primary endpoint in aPAP research. Results will be published in the European Respiratory Journal supplement by November 2022.
Savara Inc. announced that molgramostim has received the Innovation Passport designation from the UK’s MHRA for treating autoimmune pulmonary alveolar proteinosis (aPAP). This designation is a step towards accelerating market access for innovative medicines in the UK. The drug is currently being investigated in the pivotal Phase 3 trial, IMPALA-2, and previously received Fast Track and Breakthrough Therapy designations from the FDA. The designation highlights the urgent need for effective treatments for aPAP, a debilitating condition.
Savara Inc. (NASDAQ: SVRA), a biopharmaceutical company focused on rare respiratory diseases, announced its management team will present at the Jefferies Healthcare Conference on June 8, 2022, at 1:00 pm ET in New York City. A live webcast will be available on the company's website and archived for 90 days. Savara's lead program, molgramostim, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP) and utilizes the investigational eFlow® Nebulizer System.
Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company specializing in rare respiratory diseases, will present at the H.C. Wainwright Global Investment Conference on May 24, 2022, at 4:00 pm ET. The presentation will be broadcast live and available for 90 days on Savara's website.
Savara's leading program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP) and is delivered via the investigational eFlow® Nebulizer System.