Fortress Biotech, Inc 8-K, filed Nov 17, 2025
Fortress Biotech, Inc. (FBIO)
About this 8-K
Fortress Biotech, Inc filed this 8-K on November 17, 2025, reporting on events of November 14, 2025.
Items reported
- Item 8.01: Other events
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SECURITIES AND EXCHANGE COMMISSION
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Item 8.01. Other Events.
As previously disclosed, on October 1, 2025, Fortress Biotech, Inc. (the “Company”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), announced that the U.S. Food and Drug Administration (the “FDA”) had issued a Complete Response Letter relating to the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd., assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium.
On November 14, 2025, Sentynl notified Cyprium that Sentynl had resubmitted the NDA for CUTX-101 to the FDA. Cyprium will retain ownership over any Priority Review Voucher that may be issued upon NDA approval and is eligible to receive royalties and up to $129 million in aggregate development and sales milestones.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Fortress Biotech, Inc. | ||
| (Registrant) | ||
| Date: November 17, 2025 | ||
| By: | /s/ David Jin | |
| David Jin | ||
| Chief Financial Officer | ||