#USA #New York #Class Action #Savara Inc #MOLBREEVI

Pomerantz Law Firm Files Class Action Against Savara Inc.

Pomerantz LLP has officially announced the initiation of a class action lawsuit against Savara Inc., a biopharmaceutical company specializing in rare respiratory diseases, along with certain listed officers. This lawsuit, filed in the United States District Court for the Eastern District of Pennsylvania, targets all individuals and entities who purchased or acquired Savara securities during the period from March 7, 2024, to May 23, 2025. The complaint aims to address violations of federal securities laws and seeks remediation under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, along with Rule 10b-5.

Background of the Case

The class period mentioned encompasses critical moments for Savara, particularly related to its lead product candidate, MOLBREEVI (also known as molgramostim), which is currently undergoing Phase 3 clinical trials for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). This rare lung disease can lead to debilitating complications, and Savara has strategically positioned MOLBREEVI as a potential industry-changing therapy. As part of its efforts, the company had initiated a rolling submission for a Biologics License Application (BLA) with the FDA, indicating a strong belief in the drug’s efficacy based on trial results.

However, the complaint asserts that throughout the class period, Savara and its executives allegedly made false and misleading statements regarding the viability of MOLBREEVI's BLA, particularly related to its Chemistry, Manufacturing, and Controls (CMC). It claims that these statements led investors to believe the BLA stood in good stead for approval when it factually lacked sufficient data, heightening the potential for delay and additional capital needs.

Key Allegations

The primary allegations include:
1. Misleading statements regarding the completeness and compliance of the MOLBREEVI BLA.
2. Failure to disclose the likelihood that the FDA would refuse to file the application based on the inadequate data provided.
3. Assertions regarding the company’s fiscal health that were not aligned with the operational realities, potentially leading to capital raising activities that might dilute existing investors' holdings.

On May 27, 2025, a turning point occurred when Savara publicly announced that it had received a refusal-to-file letter from the FDA regarding the MOLBREEVI BLA, stating that the submitted information was insufficient for substantive review. This announcement precipitated a significant drop in Savara’s stock price, declining by 31.69% to close at $1.94 per share. Market analysts reacted quickly, with firms like Guggenheim revising their price targets and expressing concerns about the company's ability to maintain profitability.

This scenario paints a distressing picture for Savara, as they had maintained prior communications suggesting strong fiscal discipline and a well-capitalized situation that would see them through to late 2026 or even into 2027.

The Next Steps for Investors

Current investors who acquired shares of Savara securities during the designated period are encouraged to act promptly, as those wishing to appoint themselves as Lead Plaintiff must do so by November 7, 2025. Legal counsel information can be accessed through Pomerantz LLP’s website, where potential class members can find further guidance and discussions regarding their claims.

Conclusion

Pomerantz LLP, well-known for its resilience in corporate litigation, continues to be a formidable advocate for investors’ rights. This lawsuit serves as a stark reminder of the importance of transparency and accuracy in corporate communications, especially within the specialized biopharmaceutical sector where implications on public health and investor interests are profoundly intertwined.

For further updates on the case or legal actions, individuals are advised to stay tuned to Pomerantz’s communications or reach out directly to their legal contacts.

Contact Information:
Danielle Peyton
Pomerantz LLP
Email: [email protected]
Phone: 646-581-9980 Ext. 7980