Pomerantz Law Firm Initiates Class Action Lawsuit Against Savara Inc. Amid Regulatory Issues
On October 13, 2025, Pomerantz LLP, a prominent law firm specializing in class action lawsuits, unveiled the initiation of a class action against Savara Inc., a clinical-stage biopharmaceutical company. The lawsuit was filed in the United States District Court for the Eastern District of Pennsylvania and pertains to all individuals and entities, excluding the defendants, who purchased or otherwise acquired Savara securities from March 7, 2024, to May 23, 2025, collectively referred to as the "Class Period." Investors are seeking to recover losses resulting from the alleged violations of federal securities laws by Savara and certain of its high-ranking officials.
The legal action primarily addresses claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, alongside Rule 10b-5. These frameworks are designed to protect investors from misleading statements and deceptive practices in the securities market. Pomerantz Law Firm represents those affected by what they allege to be false and misleading assertions concerning the company's financial health and business prospects.
Savara, focusing on rare respiratory diseases, is currently developing its leading candidate, MOLBREEVI (molgramostim). This inhaled treatment is undergoing a pivotal Phase 3 clinical trial aimed at addressing autoimmune pulmonary alveolar proteinosis (aPAP), a severe lung condition. The firm has made bold claims about its financial positioning, asserting it is “sufficiently capitalized” to last through 2026, if not longer.
In December 2024, Savara began submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI, a step billed as a major milestone for new treatment avenues for aPAP, stating their product could significantly improve patient outcomes where no other approved medications are available in the U.S. and Europe. However, the company now faces scrutiny regarding the sufficiency of the data provided in the BLA submission.
The class action alleges that throughout the Class Period, Savara and its executives made various materially misleading statements about the company’s operations, prospects, and the status of the MOLBREEVI BLA. Key accusations include that the BLA did not meet necessary standards regarding chemistry, manufacturing, and controls (CMC), which are critical for FDA approval. There are allegations that due to the lack of complete information, the FDA was unlikely to approve the application in its current format.
Moreover, the lawsuit suggests that these misleading statements concealed the likelihood of regulatory delays, increasing the risk of Savara needing to raise additional capital as its financial stability came into question amid growing expenses related to product development.
The situation worsened on May 27, 2025, when Savara disclosed it received a refusal-to-file letter from the FDA, indicating the BLA was deemed incomplete. Subsequent analyst reports reacted negatively to this news, predicting further delays and a potential secondary stock offering that could dilute existing shareholder value. As a consequence, Savara's stock plummeted by 31.69%, closing at $1.94 per share on the same day.
Savara's reverse disclosure of its anticipated timelines for the BLA has raised alarm among investors, further escalating tensions surrounding the case. With plans now to resubmit the application in December 2025—contrary to prior assertions of a submission completion in early 2025—the lawsuit highlights the significant risks investors face when corporate communications misalign with company performance and regulatory realities.
For investors who acquired Savara securities during the Class Period, there remains a limited window until November 7, 2025, to request the Court appoint them as Lead Plaintiff in the class action. Interested parties can download a copy of the complaint from Pomerantz's website and should consider reaching out to the firm for further information on their legal standing.
As this legal battle unfolds, it underscores the critical importance of transparency and accurate disclosure in the biotech sector, which operates under a high degree of public scrutiny amidst its promise to deliver groundbreaking medical advances. Investors are urged to stay informed as the developments progress.
Background of the Case
The legal action primarily addresses claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, alongside Rule 10b-5. These frameworks are designed to protect investors from misleading statements and deceptive practices in the securities market. Pomerantz Law Firm represents those affected by what they allege to be false and misleading assertions concerning the company's financial health and business prospects.
Savara, focusing on rare respiratory diseases, is currently developing its leading candidate, MOLBREEVI (molgramostim). This inhaled treatment is undergoing a pivotal Phase 3 clinical trial aimed at addressing autoimmune pulmonary alveolar proteinosis (aPAP), a severe lung condition. The firm has made bold claims about its financial positioning, asserting it is “sufficiently capitalized” to last through 2026, if not longer.
In December 2024, Savara began submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI, a step billed as a major milestone for new treatment avenues for aPAP, stating their product could significantly improve patient outcomes where no other approved medications are available in the U.S. and Europe. However, the company now faces scrutiny regarding the sufficiency of the data provided in the BLA submission.
Allegations Against Savara
The class action alleges that throughout the Class Period, Savara and its executives made various materially misleading statements about the company’s operations, prospects, and the status of the MOLBREEVI BLA. Key accusations include that the BLA did not meet necessary standards regarding chemistry, manufacturing, and controls (CMC), which are critical for FDA approval. There are allegations that due to the lack of complete information, the FDA was unlikely to approve the application in its current format.
Moreover, the lawsuit suggests that these misleading statements concealed the likelihood of regulatory delays, increasing the risk of Savara needing to raise additional capital as its financial stability came into question amid growing expenses related to product development.
The situation worsened on May 27, 2025, when Savara disclosed it received a refusal-to-file letter from the FDA, indicating the BLA was deemed incomplete. Subsequent analyst reports reacted negatively to this news, predicting further delays and a potential secondary stock offering that could dilute existing shareholder value. As a consequence, Savara's stock plummeted by 31.69%, closing at $1.94 per share on the same day.
Implications for Investors
Savara's reverse disclosure of its anticipated timelines for the BLA has raised alarm among investors, further escalating tensions surrounding the case. With plans now to resubmit the application in December 2025—contrary to prior assertions of a submission completion in early 2025—the lawsuit highlights the significant risks investors face when corporate communications misalign with company performance and regulatory realities.
For investors who acquired Savara securities during the Class Period, there remains a limited window until November 7, 2025, to request the Court appoint them as Lead Plaintiff in the class action. Interested parties can download a copy of the complaint from Pomerantz's website and should consider reaching out to the firm for further information on their legal standing.
As this legal battle unfolds, it underscores the critical importance of transparency and accurate disclosure in the biotech sector, which operates under a high degree of public scrutiny amidst its promise to deliver groundbreaking medical advances. Investors are urged to stay informed as the developments progress.
Topics Financial Services & Investing）
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