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INVESTOR ALERT: Investigation of Fortress Biotech, Inc. (FBIO) Announced by Holzer & Holzer, LLC

1. FBIO faced an FDA Complete Response Letter regarding CUTX-101 approval. 2. CRL cited cGMP deficiencies in CUTX-101 manufacturing facility. 3. Legal investigation initiated for potential securities law violations. 4. Stock price dropped following CRL announcement. 5. Shareholders encouraged to consult with attorneys for recovery options.

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FAQ

Why Very Bearish?

The Complete Response Letter and manufacturing deficiencies suggest regulatory hurdles, mimicking past cases where stock suffered declines like Zosano Pharma.

How important is it?

The FDA's rejection and legal inquiry indicate significant risk to FBIO's market position and share value.

Why Short Term?

The immediate stock impact follows FDA communication, but recovery depends on future progress with manufacturing issues.

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CYPT
ATLANTA, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Fortress Biotech, Inc. (“Fortress” or the “Company”) (NASDAQ: FBIO) complied with federal securities laws. On October 1, 2025, Fortress and its subsidiary, Cyprium Therapeutics, Inc., announced that the FDA issued a Complete Response Letter (“CRL”) relating to the New Drug Application (“NDA”) for CUTX-101 and that the “CRL noted cGMP deficiencies had been observed at the facility where CUTX-101 is manufactured.”  Following this news, the price of the Company’s stock dropped. If you purchased Fortress stock and suffered a loss on that investment, you are encouraged to contact Corey Holzer, Esq. at cholzer@holzerlaw.com or Joshua Karr, Esq. at jkarr@holzerlaw.com, call our toll-free number at (888) 508-6832, or visit our website at www.holzerlaw.com/case/fortress-biotech/ to discuss your legal rights.   Holzer & Holzer, LLC, an ISS top rated securities litigation law firm for 2021, 2022, and 2023, dedicates its practice to vigorous representation of shareholders and investors in litigation nationwide, including shareholder class action and derivative litigation. Since its founding in 2000, Holzer & Holzer attorneys have played critical roles in recovering hundreds of millions of dollars for shareholders victimized by fraud and other corporate misconduct. More information about the firm is available through its website, www.holzerlaw.com, and upon request from the firm. Holzer & Holzer, LLC has paid for the dissemination of this promotional communication, and Corey Holzer is the attorney responsible for its content.  CONTACT:  Corey Holzer, Esq.(888) 508-6832 (toll-free)cholzer@holzerlaw.com

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