Fortress Biotech and Cyprium Therapeutics Announce FDA Acceptance of CUTX-101 NDA Resubmission
Fortress Biotech, Inc. (FBIO)
Last fortress biotech, inc. earnings: 11/12 07:30 am
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fortressbiotech.com
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Source: GlobeNewswire
MIAMI, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the resubmission of the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. The resubmission has been accepted as a Class 1 resubmission and as a result, the new Prescription Drug User Fee Act (PDUFA) target action date for the NDA is January 14, 2026. In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly owned by Zydus Lifesciences, Ltd. (“Zydus Group”), assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium. On November 14, 2025, Sentynl resubmitted the revised NDA after receiving a complete response letter (“CRL”) from the FDA on September 30, 2025, which CRL cited observations re
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News
- Fortress Biotech, Inc. (NASDAQ:FBIO) Could Be Less Than A Year Away From Profitability [Yahoo! Finance]Yahoo! Finance
- Fortress Biotech (NASDAQ:FBIO) was upgraded by analysts at Zacks Research from a "hold" rating to a "strong-buy" rating.MarketBeat
- Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Approval of ZYCUBO® (copper histidinate), the First and Only Approved Treatment for Menkes Disease in the United StatesGlobeNewswire
- Fortress Biotech and Cyprium Therapeutics Announce FDA Acceptance of CUTX-101 NDA Resubmission [Yahoo! Finance]Yahoo! Finance
- Fortress Biotech (NASDAQ:FBIO) had its "sell (d)" rating reaffirmed by analysts at <a style="font-weight:bold" href="https://weissratings.com/">Weiss Ratings</a>.MarketBeat
FBIO
Sec Filings
- 1/13/26 - Form 8-K
- 1/5/26 - Form 4
- 1/5/26 - Form 4
- FBIO's page on the SEC website