On October 13, 2025, Pomerantz LLP announced that it is investigating claims on behalf of investors in Fortress Biotech Inc. (NASDAQ: FBIO). The investigation focuses on alleged securities fraud or other unlawful business practices by Fortress and certain officers or directors.
The investigation follows a separate regulatory event on October 1, 2025, when Fortress and its subsidiary Cyprium Therapeutics received a Complete Response Letter from the U.S. Food and Drug Administration for the New Drug Application of CUTX‑101. The CRL cited current good manufacturing practice deficiencies at the manufacturing facility for CUTX‑101.
The initiation of a securities investigation represents a significant regulatory development for Fortress Biotech, as it may lead to legal proceedings, potential penalties, or remedial actions that could affect the company’s governance, financial reporting, and investor confidence. Investors are advised to monitor the progress of the investigation and any resulting disclosures.
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