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Investing.com - Oppenheimer raised its price target on Savara (NASDAQ:SVRA) stock to $6.00 from $5.00 on Friday, while maintaining an Outperform rating following the company’s second-quarter financial report and business update. The stock, currently trading at $3.01, has shown strong momentum with a 14% gain over the past week, according to InvestingPro data.
The research firm cited Savara’s alignment with the FDA on Chemistry, Manufacturing, and Controls (CMC) information required to resubmit the Biologics License Application (BLA) for MOLBREEVI in autoimmune pulmonary alveolar proteinosis (aPAP), now planned for December 2025.
Savara has addressed the sole deficiency around CMC and named FUJIFILM as the new drug substance manufacturer, positioning the company for a potential August 2026 approval if granted Priority Review.
Oppenheimer noted the unmet need for therapies in aPAP and the robust Phase 3 IMPALA-2 data, viewing MOLBREEVI as well-positioned for commercial success with approximately 1,000 patients in line of sight at launch time.
The company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency and UK Medicines and Healthcare products Regulatory Agency in the first quarter of 2026.
In other recent news, Savara Inc. held its annual meeting of stockholders, where six directors were elected to the company’s board. The meeting also saw the ratification of RSM US LLP as the company’s independent registered public accounting firm for the fiscal year ending December 31, 2025. Savara has faced a regulatory setback as the FDA issued a Refusal to File (RTF) letter for its Biologics License Application for Molbreevi, requesting additional Chemistry, Manufacturing, and Controls data. This development has influenced analyst ratings, with Oppenheimer assuming coverage of Savara stock with an Outperform rating and a $5 price target, while H.C. Wainwright downgraded the stock to Neutral with a $2 price target.
Guggenheim maintained a Buy rating but lowered its price target to $8, following discussions with Savara’s management about the regulatory challenges. Evercore ISI also adjusted its price target to $2 from $3, retaining an In Line rating, and noted the possibility of a resubmission of the application in the fourth quarter of this year. Despite these challenges, Savara’s management remains optimistic about obtaining approval for Molbreevi, planning to engage with the FDA in a Type A Meeting to clarify data requirements. These developments come as the company continues to work on addressing the FDA’s concerns and moving forward with its application process.
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