#United States #Philadelphia #Pomerantz LLP #Savara Inc. #MOLBREEVI

Pomerantz Law Firm Files Class Action Against Savara Inc.

On October 3, 2025, Pomerantz LLP announced that it has filed a class action lawsuit against Savara Inc. (NASDAQ: SVRA), along with certain of its top officials, in the United States District Court for the Eastern District of Pennsylvania. This legal action is aimed at serving individuals and entities who purchased or acquired Savara securities during the period from March 7, 2024, to May 23, 2025, referred to as the “Class Period.” The allegations center around violations of federal securities laws that purportedly resulted in damages to investors.

The complaint underscores the defendants' alleged misleading statements and omissions regarding Savara's business operations, particularly surrounding its drug candidate, MOLBREEVI (molgramostim). Savara, known for its focus on rare respiratory diseases, has been working on the approval of MOLBREEVI, which is currently in Phase 3 clinical trials aimed at treating autoimmune pulmonary alveolar proteinosis (aPAP). This condition is characterized by severe respiratory dysfunction due to the accumulation of surfactant in the lungs.

Allegations Against Savara

The lawsuit claims that, throughout the Class Period, the defendants provided materially inaccurate representations concerning the status and prospects of the company and its lead product. According to the allegations:

1. Inadequate BLA Submission: The complaint accuses Savara of submitting an incomplete Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI, lacking necessary details about the product's chemistry, manufacturing, and controls (CMC).
2. Regulatory Approval Denied: As a result of the deficiencies, the FDA reportedly issued a refusal-to-file notice on May 27, 2025, indicating that the BLA was not ready for review, thus delaying potential approval and creating a scramble for additional data.
3. Financial Projections Misleading: Savara’s assertions about being able to continue operations through 2026 or into 2027 without needing further capital are challenged, with the claim that delays in obtaining approval would force the company into subsequent capital raises that may dilute existing shareholders' investments.

Following the denial from the FDA regarding the BLA, analysts swiftly adjusted their projections for Savara’s stock. Guggenheim published a report reducing its price target from $9.00 to $8.00 and expressed skepticism about Savara’s path to profitability until as late as 2028.

The stock reacted sharply, plummeting by nearly 32% per share immediately after the FDA news broke, reflecting growing investor concerns about the company's future set against these regulatory hurdles.

Next Steps for Investors

For investors involved during the Class Period, there’s a window until November 7, 2025, to request to be appointed as Lead Plaintiff in the action. Interested parties can access a copy of the complaint and other pertinent details on Pomerantz’s official website, maintaining an open channel for inquiries via email or telephone numbers highlighted by the firm for questions relating to the lawsuit.

Pomerantz LLP, with its long history of standing up for shareholders affected by corporate misconduct, continues its pursuit of justice and accountability in securities fraud cases. The firm, recognized as a leader in class action litigation, hopes to recover damages for those affected by the alleged transgressions by Savara and its executives.

For further information or support, investors can contact Danielle Peyton at Pomerantz LLP.

Conclusion

This case highlights the ongoing challenges investors face in the biotechnology sector, particularly surrounding clinical trials and regulatory approvals. As stakeholders follow the developments, the implications of the lawsuit will be critical for Savara's future and investor confidence.

For more information about this class action suit and how to get involved, please visit Pomerantz Law Firm.