Fortress Biotech’s Subsidiary Cyprium Therapeutics Receives FDA Acceptance for CUTX-101 NDA Review

Fortress Biotech, Inc. (NASDAQ: FBIO) disclosed in a recent 8-K filing that its majority-owned subsidiary, Cyprium Therapeutics, Inc., has achieved a significant milestone in the drug approval process. The U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for CUTX-101 (Copper Histidinate) for priority review, with a target action date set for June 30, 2025.

This promising development follows the transition of development and commercialization responsibilities for CUTX-101 from Cyprium to Sentynl Therapeutics, Inc., a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (Zydus Group) in December 2023. Sentynl successfully completed the NDA submission and will now spearhead commercialization efforts pending approval.

Under the terms, Cyprium stands to retain ownership of any Priority Review Voucher that may be granted upon NDA approval. Additionally, Cyprium is eligible to receive royalties and up to $129 million in aggregate development and sales milestones.

Fortress Biotech originally established Cyprium in 2017 and currently holds approximately 76% ownership in the subsidiary. The company’s Chief Financial Officer, David Jin, duly caused the report to be signed on January 6, 2025, in compliance with the Securities Exchange Act of 1934.

This acceptance by the FDA marks a significant step forward in the advancement of CUTX-101 towards potential approval, positioning both Fortress Biotech and Cyprium Therapeutics favorably in the pharmaceutical landscape.

Please consult the original 8-K SEC Filing for further information and disclosures regarding this event.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read Fortress Biotech’s 8K filing here.

About Fortress Biotech

Fortress Biotech, Inc, a biopharmaceutical company, develops dermatology, pharmaceutical, and biotechnology products in the United States. The company markets dermatology products, such as Qbrexza a medicated cloth towelette for the treatment of primary axillary hyperhidrosis; Accutane capsules for severe recalcitrant nodular acne; Amzeeq for severe acne vulgaris; Zilxi, a topical foam; Exelderm cream and solution for topical use; Targadox an oral doxycycline drug for adjunctive therapy for severe acne; Luxamend; sulconazole nitrate cream and solution for tinea cruris and tinea corporis; and doxycycline hyclate tablet.