Globenewswireยท2025-09-16 18:32Core Viewpoint - Savara Inc. is facing a securities fraud class action lawsuit following a significant decline in its stock price after the FDA issued a refusal to file letter for its MOLBREEVI BLA therapy [3][4]. Group 1: Company Overview - Savara Inc. (NASDAQ:SVRA) is involved in the development of therapies, specifically the MOLBREEVI BLA intended for treating patients with aPap [3]. - The company experienced a stock price drop of approximately 31.69%, from $2.84 on May 23, 2025, to $1.94 on May 27, 2025, after the FDA's announcement [3]. Group 2: Lawsuit Details - The class action lawsuit is on behalf of investors who purchased Savara securities between March 7, 2024, and May 23, 2025 [4]. - Allegations in the lawsuit include that Savara made false or misleading statements regarding the completeness of the MOLBREEVI BLA submission and the likelihood of FDA approval [4]. - The lawsuit claims that the company failed to disclose the need for additional data related to Chemistry, Manufacturing, and Controls (CMC), which impacted the approval timeline and raised concerns about the need for additional capital [4].