Pomerantz Law Firm Initiates Class Action Against Savara Inc. for Securities Violations

Pomerantz Law Firm Files Class Action Against Savara Inc.

Date: September 18, 2025
Location: New York, USA

Pomerantz LLP has announced the filing of a class action lawsuit against Savara Inc. (NASDAQ: SVRA) and certain of its executives. The case has been registered in the United States District Court for the Eastern District of Pennsylvania and is aimed at protecting investors who purchased or acquired Savara securities between March 7, 2024, and May 23, 2025.

Overview of the Lawsuit

The legal action seeks to recover damages caused by alleged violations of federal securities laws. The lawsuit addresses claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, highlighting that the defendants made misleading statements regarding the company’s operations and financial prospects.

Investors who acquired Savara securities during the class period can request to be appointed as Lead Plaintiff until November 7, 2025. Those interested can find further details and initiate inquiries through Pomerantz’s official website.

Background on Savara Inc.

Savara is a biopharmaceutical entity in the clinical stage that specializes in addressing rare respiratory diseases. Its main product candidate is MOLBREEVI (molgramostim), which is currently undergoing a Phase 3 clinical trial targeting autoimmune pulmonary alveolar proteinosis (aPAP), a rare and debilitating lung condition. Savara claims that MOLBREEVI could potentially transform treatment options for aPAP, a disease currently without FDA-approved therapies in the U.S. and Europe.

In late 2024, Savara began submitting a Biologics License Application (BLA) for MOLBREEVI to the FDA, expressing confidence in its favorable benefit-risk profile based on results from the IMPALA-2 trial. However, recent allegations suggest that the BLA may lack sufficient information, which poses a risk to its approval process.

Allegations Against Savara

Throughout the class period, it is claimed that Savara’s executives made materially false or misleading statements about the company’s business health and regulatory progress. The lawsuit alleges the following key points:
1. The BLA for MOLBREEVI was not sufficiently complete, failing to meet FDA standards regarding chemistry, manufacturing, and controls (CMC).
2. As a result, the likelihood of FDA approval was diminished, making it improbable that the submission could be completed within the previously communicated timelines.
3. The potential delays in gaining regulatory approval increased the likelihood of needing additional capital, thus impacting shareholder interests adversely.
4. The statements from company officials were misleading and failed to disclose significant risks associated with the BLA submission.

On May 27, 2025, the company faced a backlash when it revealed that it received a refusal letter from the FDA concerning the BLA for MOLBREEVI. This letter indicated that the submission was incomplete for a substantive review, primarily due to missing data on CMC.

Market Reaction

Following the FDA's communication, analysts swiftly adjusted their outlook on Savara. Guggenheim raised concerns about potential capital raises in the near future, predicting shares could dilute current shareholder value. This led to a significant downfall in Savara’s stock, which plummeted by about 31.69%, closing at $1.94 per share post-announcement.

Conclusion

Pomerantz LLP has built a strong reputation in the realm of corporate and securities class litigation, recovering billions for investors over its extensive history. As this situation unfolds, investors in Savara Inc. will need to monitor the lawsuit's developments and potential implications for their investments closely. Those with questions or seeking assistance can reach out to Pomerantz's experienced team for guidance on joining the class action lawsuit.

For more detailed information, individuals can visit the Pomerantz website or contact them directly.

Disclaimer: This press release serves informational purposes and does not constitute legal advice. Previous outcomes do not ensure similar results.