Fortress Biotech, INC. 8-K Filing
Ticker: FBIOP · Form: 8-K · Filed: Nov 17, 2025 · CIK: 1429260
Sentiment: neutral
Filing Stats: 482 words · 2 min read · ~2 pages · Grade level 11.4 · Accepted 2025-11-17 07:30:33
Key Financial Figures
- $129 million — eligible to receive royalties and up to $129 million in aggregate development and sales mile
Filing Documents
- tm2531443d1_8k.htm (8-K) — 28KB
- 0001104659-25-112945.txt ( ) — 232KB
- fbio-20251114.xsd (EX-101.SCH) — 4KB
- fbio-20251114_def.xml (EX-101.DEF) — 26KB
- fbio-20251114_lab.xml (EX-101.LAB) — 36KB
- fbio-20251114_pre.xml (EX-101.PRE) — 25KB
- tm2531443d1_8k_htm.xml (XML) — 6KB
01. Other
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
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