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 States
Fortress Biotech, Inc. (FBIO)
Last fortress biotech, inc. earnings: 11/12 07:30 am
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Source: GlobeNewswire
Rare Pediatric Disease Priority Review Voucher (PRV) granted by FDA at approval to be transferred from Sentynl Therapeutics to Cyprium Cyprium eligible to receive tiered royalties and up to $129 million in aggregate development and sales milestones from Sentynl Therapeutics MIAMI, Jan. 13, 2026 (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 approved ZYCUBO® (copper histidinate, formerly known as CUTX-101) for the treatment of Menkes disease in pediatric patients. In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences Limited (“Zydus Group”), assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium. A Rare Pediatric Disease Priority Review Voucher (PRV) was issued in connection with FDA approval and,
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News
- 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 FDA Acceptance of CUTX-101 NDA Resubmission [Yahoo! Finance]Yahoo! Finance
- Fortress Biotech and Cyprium Therapeutics Announce FDA Acceptance of CUTX-101 NDA ResubmissionGlobeNewswire
- 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
- Fortress Biotech (NASDAQ:FBIO) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=FBIO&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street ZMarketBeat
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