Fortress Biotech, Inc. Securities Fraud Investigation

Shamis & Gentile, P.A. is investigating claims on behalf of investors of Fortress Biotech, Inc. ("Fortress Biotech" or the "Company") (FBIO). Impacted investors are advised to contact the firm now.

The investigation concerns whether Fortress Biotech and certain of its officers and/or directors have allegedly engaged in securities fraud or other unlawful business practices.

Scope of the Investigation

Throughout 2025, the Company allegedly highlighted the progress of its New Drug Application (NDA) for CUTX-101 in earnings releases, SEC filings and investor communications, emphasizing the U.S. Food and Drug Administration's ("FDA") acceptance of the NDA for priority review and expressing confidence in the anticipated approval by the stated PDUFA goal date of September 30, 2025.

However, Fortress Biotech seemingly failed to disclose that the FDA had identified current Good Manufacturing Practice (cGMP) deficiencies at the facility responsible for manufacturing CUTX-101.

Attorneys are investigating whether the Company may have omitted cautionary language about the specific regulatory risks tied to these manufacturing issues, instead providing only generic risk factors in its public filings. These seemingly incomplete disclosures appear to contradict the optimistic narrative presented to investors and may have concealed material adverse information that ultimately resulted in significant losses once the true status of the NDA review process became known.

FDA Response and Market Impact

On October 1, 2025, Fortress Biotech announced that the FDA had issued a Complete Response Letter (CRL) for CUTX-101, citing cGMP deficiencies at the manufacturing facility. The Company further disclosed that no safety or efficacy concerns were identified, but that it and its partner would work with the FDA on a resubmission.

On this news, Fortress Biotech's stock price fell approximately 30.8%, from $3.70 on September 30, 2025, to close at $2.56 on October 1, 2025, erasing approximately $35 to $40 million in market capitalization and causing substantial losses to investors.

What Investors Can Do

If you purchased or acquired Fortress Biotech (NASDAQ: FBIO) in 2025 prior to the September 30 disclosures, you may be eligible to seek compensation for your losses. Contact Shamis & Gentile today to discuss your options.

Shamis & Gentile, P.A. stands out as an advocate for investors who are victims of securities fraud. The firm is committed to securing recoveries for investors who have incurred damages due to false and misleading statements or other corporate misconduct by public companies. Shamis & Gentile has recovered over $1 billion for consumers nationwide. Its extensive experience, expertise and resources enable the firm to resolve disputes in a wide range of matters, including class actions, mass torts and mass arbitrations.

Attorney advertising. Prior results do not guarantee similar outcomes.