Fortress Biotech, Inc. Securities Lawsuit Investigation

Shamis & Gentile P.A., a law firm that advocates for investors who are victims of securities fraud, is investigating potential claims against Fortress Biotech, Inc. (FBIO)

If you purchased or acquired Fortress Biotech securities and suffered losses, you may be eligible to join this securities investigation and seek compensation.

About Fortress Biotech

Fortress Biotech is a biopharmaceutical company focused on acquiring, developing, and commercializing novel pharmaceutical and biotechnology products. The company operates through multiple subsidiaries and partners, with a portfolio that includes both marketed and development-stage products.

One of Fortress Biotech’s core assets is CUTX-101, a treatment candidate developed by its subsidiary Cyprium Therapeutics. CUTX-101 is intended for patients with Menkes disease, a rare pediatric disorder.

Potential Concerns Under Investigation

Lawyers are investigating whether Fortress adequately disclosed any manufacturing risks that could impact approval, in light of the CRL’s cGMP findings.

Throughout 2025, Fortress Biotech allegedly issued several positive statements about the progress of the New Drug Application (NDA) for CUTX-101. CEO Rosenwald expressed optimism about the approval process, stating "We also look forward to the PDUFA goal date,” which allegedly conveyed confidence in a smooth regulatory path.

However, legal professionals may examine whether these statements omitted material information about manufacturing deficiencies at the facility producing CUTX-101.

On October 1, 2025, Fortress Biotech and its subsidiary Cyprium publicly disclosed that the FDA had issued a Complete Response Letter (CRL) for CUTX-101, citing “cGMP deficiencies had been observed at the facility where CUTX-101 is manufactured.” The company clarified that no safety or efficacy issues were identified, but the manufacturing problems were significant enough to prevent approval.

Attorneys may investigate if Fortress Biotech adequately disclosed the existence and potential impact of these manufacturing deficiencies prior to the FDA’s CRL. The company’s public filings and press releases during the class period did not mention any specific concerns raised by FDA inspections.

Instead, filings allegedly included only generic risk factors in public statements, such as the possibility that the FDA may determine “that our manufacturing processes or facilities or those of third-party manufacturers with which we or our collaborators contract for clinical supplies or plan to contract for commercial supplies, do not satisfactorily comply with cGMPs,” without providing any company-specific warnings.

This lack of tailored disclosure may have left investors with an unduly optimistic impression about the likelihood of FDA approval.

The investigation may also focus on the stock’s reaction to the October 1, 2025, announcement. Following news of the CRL, Fortress Biotech’s stock price dropped 30.8%, falling from about $3.70 on September 30 to roughly $2.56 on October 1. This represents a loss of about $1.20 per share and an aggregate loss of tens of millions of dollars in shareholder value.

Securities attorneys might examine whether the timing and content of Fortress Biotech’s disclosures misled investors by failing to mention the regulatory risks that ultimately led to the CRL. The investigation could also consider whether senior executives were aware of the manufacturing issues and whether their public statements or omissions contributed to investor harm.

Your Rights and Next Steps

This is an active investigation into whether Fortress Biotech may have violated federal securities laws by making misleading statements or omitting key information about CUTX-101’s regulatory status. Investors who purchased Fortress Biotech securities during the proposed class period, and suffered losses tied to the company’s disclosures may have legal rights.

Lawyers are ready to help investors understand their options. If the investigation uncovers evidence of wrongdoing, it may lead to a securities class action lawsuit on behalf of affected shareholders. Participating in the investigation is an important step for investors seeking to protect their interests and potentially recover losses.

Investors are encouraged to gather records of their Fortress Biotech purchases and sales during the relevant period. By joining the investigation, shareholders can help ensure that their voices are heard and that any potential recovery is distributed fairly among those who were harmed.

You May Be Entitled to Compensation

Securities investigations are time-sensitive, and it is important for investors to act quickly. If you purchased Fortress Biotech securities and experienced losses following the company’s disclosures about CUTX-101, you may be eligible to join any potential class action and seek compensation.

To participate in the investigation and learn more about your rights, complete the form below.