Pomerantz Law Firm Files Class Action Against Savara Inc. Over Securities Violations

Class Action Lawsuit Against Savara Inc. Revealed

On September 28, 2025, Pomerantz LLP announced the filing of a class action lawsuit against Savara Inc., a clinical-stage biopharmaceutical company. The firm is representing investors who purchased or otherwise acquired Savara securities between March 7, 2024, and May 23, 2025. This legal action aims to address alleged violations of federal securities laws attributed to Savara and some of its top officers.

The lawsuit was filed in the United States District Court for the Eastern District of Pennsylvania and is registered under docket number 25-cv-05147. Investors affected by these actions are encouraged to step forward and may request to be appointed as Lead Plaintiff for the class until November 7, 2025. Those interested can reach out through Pomerantz's legal representatives to discuss their involvement.

Savara is known for its focus on addressing rare respiratory diseases, with its lead product candidate interestingly being MOLBREEVI (or molgramostim), which is an inhaled granulocyte-macrophage colony-stimulating factor. The product is currently in a pivotal Phase 3 clinical trial known as IMPALA-2, designed to treat autoimmune pulmonary alveolar proteinosis (aPAP), a severe lung disease with no approved treatments available in the US or Europe. The company, founded with the vision of transforming treatment protocols in this area, has maintained that it is financially sustainable until at least 2026, on the back of solid investments in its lead product.

In December 2024, Savara began submitting its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI for aPAP. This was followed by strong claims from Savara about the drug's favorable benefit-risk profile, emphasizing how it could change current treatment methods for aPAP. Concurrently, the company communicated its expectations for completing the BLA submission by the first quarter of 2025.

However, discrepancies quickly surfaced between Savara's public representations and the realities of the situation. Allegations in the lawsuit claim Savara's leadership misrepresented key information regarding MOLBREEVI's production and regulatory submission processes. Reportedly, the BLA lacked important details about chemistry, manufacturing, and controls (CMC), which are critical for FDA approval. This shortfall raised substantial doubts about the likelihood that Savara would meet its regulatory submission timeline, increasing the potential need for supplemental capital.

The gravity of the situation escalated when, on May 27, 2025, Savara announced it received a refusal-to-file letter from the FDA concerning the MOLBREEVI application. The notification suggested that the application was incomplete, triggering widespread concern about the company's viability and compliance with federal regulations. Subsequent analysis by Guggenheim saw a price target revision for Savara stock down to $8.00 from $9.00, projecting potential capital raises would likely dilute existing shares.

The fallout was immediate, with Savara's share price plummeting by over 30% following the negative news. Furthermore, a press release from August 13, 2025, post-Class Period, indicated Savara planned to further postpone the BLA resubmission until December 2025, contradicting earlier commitments.

Pomerantz LLP is noted for its esteemed position in corporate and securities litigation. Founded by the late Abraham L. Pomerantz, the firm has a longstanding history of advocating for the rights of victims in securities fraud cases which has resulted in significant financial recoveries for many. Potential class members or those who wish to seek justice in this instance can follow up with Pomerantz to understand the procedural aspects of the lawsuit and their options moving forward.

In conclusion, as the case progresses, many will be watching closely to ascertain the implications of Savara's actions on its operations and stock performance, while Pomerantz continues its commitment to seeking justice for those affected by the alleged misconduct.