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LANGHORNE, Pa. - Savara Inc. (NASDAQ:SVRA), a clinical-stage biopharmaceutical company with a market capitalization of $564.5 million, has announced the completion of its Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for its investigational drug MOLBREEVI, aimed at treating autoimmune pulmonary alveolar proteinosis (aPAP). The submission is a significant step for the company and those affected by aPAP, a rare lung disease. According to InvestingPro data, Savara maintains a strong financial position with more cash than debt and a healthy current ratio of 17.7, providing substantial runway for its development programs.
Matt Pauls, Chair and CEO of Savara, expressed optimism about the data supporting MOLBREEVI’s efficacy in improving pulmonary gas exchange and clinical symptoms of aPAP. Savara has requested a Priority Review for the application, which, if granted, could expedite the FDA’s review process to six months. The company is preparing for a potential commercial launch in early 2026, pending approval. Wall Street analysts appear to share this optimism, with price targets ranging from $5 to $16, suggesting significant upside potential from the current price of $2.69. For deeper insights into Savara’s valuation and growth prospects, InvestingPro subscribers can access comprehensive research reports and additional financial metrics.
The IMPALA-2 trial, which met its primary endpoint, showed that MOLBREEVI significantly improved lung function as measured by the diffusing capacity of the lungs for carbon monoxide (DLCO) over a 24-week period, with sustained effects at 48 weeks. The trial also reported improvements in patients’ quality of life and exercise capacity, highlighting the drug’s clinical benefits.
MOLBREEVI has been well-received in clinical trials, with high patient completion rates and no discontinuations due to drug-related adverse events. The drug has received Fast Track and Breakthrough Therapy Designations from the FDA, as well as Orphan Drug Designation from both the FDA and the European Medicines Agency (EMA). Additionally, it has been recognized with Innovation Passport and Promising Innovative Medicine designations by the UK’s regulatory agency.
Autoimmune pulmonary alveolar proteinosis is characterized by the accumulation of surfactant in the lungs, leading to difficulty in breathing and other severe symptoms. Current treatments are limited, making the development of MOLBREEVI particularly significant for those living with this condition.
Savara’s management team brings extensive experience in rare respiratory diseases to the development of MOLBREEVI, which is delivered via a specialized nebulizer system. As the company awaits regulatory response, it continues to focus on advancing its product candidates for rare respiratory diseases. This report is based on a press release statement issued by Savara Inc.
In other recent news, Savara Inc. has released significant retrospective outcomes data for its drug molgramostim, indicating potential therapeutic benefits for patients with autoimmune pulmonary alveolar proteinosis (aPAP). The study, published in ERJ Open Research, showed that patients who received molgramostim experienced improved lung function and a decreased need for whole lung lavage over an average period of 4.2 years. Savara is on track to complete its Biologics License Application in the U.S. by the first quarter of 2025 and plans to file a Marketing Authorization Application in Europe by the end of the same year. Additionally, Savara has set executive bonus targets for 2025, with CEO Matthew Pauls eligible for a bonus of $330,000, which is 50% of his base salary. Other executives, including Raymond Pratt and Dave Lowrance, have target bonuses set at 40% of their base salaries. The bonuses are contingent on achieving specific performance goals, with corporate measures accounting for 100% of the CEO’s target bonus and 75% for other executives. This compensation strategy aims to align executive rewards with company performance, reflecting Savara’s commitment to its strategic goals.
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