Pomerantz Law Firm Announces the Filing of a Class Action Against Savara Inc. and Certain Officers – SVRA

Core Viewpoint - A class action lawsuit has been filed against Savara Inc. and certain officers for alleged violations of federal securities laws during the Class Period from March 7, 2024, to May 23, 2025, seeking damages for affected investors [1][6]. Company Overview - Savara Inc. is a clinical-stage biopharmaceutical company focused on rare respiratory diseases, with its lead product candidate being MOLBREEVI (molgramostim), currently in a Phase 3 clinical trial for autoimmune pulmonary alveolar proteinosis (aPAP) [4]. - The company has claimed it is "sufficiently capitalized" through 2026 or into the second half of 2027 based on investments in MOLBREEVI and its fiscal discipline [4]. Regulatory Developments - In December 2024, Savara began a rolling submission of a Biologics License Application (BLA) to the FDA for MOLBREEVI, expecting to complete the submission by the end of Q1 2025 [5]. - The BLA submission must include detailed information regarding MOLBREEVI's chemistry, manufacturing, and controls (CMC) [5]. Allegations in the Lawsuit - The lawsuit alleges that Savara's executives made materially false and misleading statements about the company's business and prospects, including claims about the sufficiency of the BLA and the likelihood of FDA approval [6]. - Specific allegations include that the BLA lacked sufficient information regarding CMC, making FDA approval unlikely in its current form [6]. Market Reaction - Following the announcement of a refusal to file letter from the FDA on May 27, 2025, Savara's stock price fell by $0.90, or 31.69%, closing at $1.94 per share [7][9]. - Analysts, such as Guggenheim, revised their price target for Savara from $9.00 to $8.00, predicting that the company may not be profitable until 2028 and may need to raise additional capital [8]. Financial Updates - After the Class Period, Savara announced on August 13, 2025, that it plans to resubmit the MOLBREEVI BLA in December 2025, contrary to previous statements about completing the submission in Q1 2025 [10].