Fortress Biotech and Cyprium Therapeutics Announce an Update on the NDA for CUTX-101 [Yahoo! Finance]
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: Yahoo! Finance
MIAMI, Oct. 01, 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 issued a Complete Response Letter (“CRL”) 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. (“Zydus Group”) assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium. Cyprium expects its partner, Sentynl, will work expeditiously to address the FDA's concerns and pursue resubmission promptly. The CRL noted cGMP deficiencies had been observed at the facility where CUTX-101 is manufactured. The facility recently provided responses to the FDA's September 2025 re-inspection of the facility, and
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FBIO
News
- 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
- Fortress Biotech GAAP EPS of $0.11, revenue of $17.6M [Seeking Alpha]Seeking Alpha
- Fortress Biotech Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights [Yahoo! Finance]Yahoo! Finance
- Fortress Biotech Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights GlobeNewswire
- Fortress Biotech Q3 Earnings Preview [Seeking Alpha]Seeking Alpha
FBIO
Sec Filings
- 11/17/25 - Form 8-K
- 11/14/25 - Form 10-Q
- 11/14/25 - Form 8-K
- FBIO's page on the SEC website