Core Viewpoint - A class action has been filed against Savara Inc. for allegedly misleading investors regarding the viability of its lead drug candidate, MOLBREEVI, during a specified period [1][3]. Group 1: Allegations - The complaint states that Savara failed to disclose critical information about the MOLBREEVI Biologics License Application (BLA), including insufficient data on chemistry, manufacturing, and controls [3]. - It is alleged that the FDA was unlikely to approve the MOLBREEVI BLA in its current form, which would delay the submission timeline previously communicated to investors [3]. - The delay in regulatory approval raised concerns about the company's need to raise additional capital [3]. Group 2: Impact on Stock Price - Following the announcement of a refusal to file (RTF) letter from the FDA regarding the MOLBREEVI BLA, Savara's stock price dropped by $0.90, or 31.69%, closing at $1.94 per share on May 27, 2025 [4]. Group 3: Class Action Participation - Shareholders interested in participating as lead plaintiffs in the class action must submit their papers by November 7, 2025 [5]. - Shareholders can remain absent class members if they choose not to participate in the case [5].

Core Viewpoint - A class action lawsuit has been filed against Savara Inc. for allegedly misleading investors regarding the viability of its lead drug candidate, MOLBREEVI, during the specified class period [1][2]. Allegations - The lawsuit claims that Savara failed to disclose critical information about the MOLBREEVI Biologics License Application (BLA), including insufficient details on chemistry, manufacturing, and controls, which made FDA approval unlikely in its current form [2]. - The complaint also states that the company was unlikely to meet its previously communicated timeline for submitting the MOLBREEVI BLA, and the delay increased the likelihood of needing additional capital [2]. Stock Price Impact - Following the announcement of a refusal to file (RTF) letter from the FDA regarding the MOLBREEVI BLA, Savara's stock price dropped by $0.90, or 31.69%, closing at $1.94 per share on May 27, 2025 [3]. Class Action Participation - Shareholders interested in participating as lead plaintiffs in the class action must submit their papers by November 7, 2025, although they can remain absent class members if they choose not to take action [4]. Legal Representation - Robbins LLP operates on a contingency fee basis, meaning shareholders incur no fees or expenses unless the case is won [5].

Core Viewpoint - A class action lawsuit has been filed against Savara Inc. for allegedly misleading investors regarding the viability of its lead drug candidate, MOLBREEVI, during the specified class period [1][2]. Allegations - The complaint states that Savara failed to disclose critical information about the MOLBREEVI Biologics License Application (BLA), including insufficient details on chemistry, manufacturing, and controls, which made FDA approval unlikely in its current form [2]. - The company misrepresented the timeline for completing the BLA submission, increasing the likelihood of needing additional capital due to delays in regulatory approval [2]. Stock Price Impact - Following the announcement of a refusal to file (RTF) letter from the FDA on May 27, 2025, Savara's stock price dropped by $0.90, or 31.69%, closing at $1.94 per share [3]. Class Action Participation - Shareholders interested in serving as lead plaintiffs must submit their papers by November 7, 2025, although participation is not required to be eligible for recovery [4]. Company Background - Robbins LLP is noted for its focus on shareholder rights litigation, aiming to help shareholders recover losses and improve corporate governance since 2002 [5].

Core Viewpoint - Savara, Inc. is facing a class action lawsuit due to alleged misleading statements regarding its lead product candidate, MOLBREEVI, and its Biologics License Application (BLA) submission to the FDA [1][4]. Company Overview - Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases [3]. - The company's lead product candidate is MOLBREEVI (molgramostim), an inhaled granulocyte-macrophage colony-stimulating factor [3]. - In December 2024, Savara began a rolling submission of a BLA to the FDA for MOLBREEVI to treat aPAP [3]. Legal Issues - The class action lawsuit alleges that Savara made false or misleading statements and failed to disclose critical information about the MOLBREEVI BLA, including insufficient data on chemistry, manufacturing, and controls [4]. - The lawsuit claims that the FDA was unlikely to approve the MOLBREEVI BLA in its current form, which could delay the submission timeline and necessitate additional capital raising [4]. - On May 27, 2025, Savara announced it received a refusal to file (RTF) letter from the FDA, stating the BLA was not sufficiently complete for review, leading to a more than 31% drop in share price [5].

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].