Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
Fortress Biotech, Inc. (FBIO)
Last fortress biotech, inc. earnings: 11/12 07:30 am
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Source: GlobeNewswire
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive royalties and up to $129 million in aggregate development and sales milestones Cyprium also retains ownership over any Priority Review Voucher that may be issued at NDA approval MIAMI, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced the acceptance for review of the New Drug Application (“NDA”) by the U.S. Food and Drug Administration (“FDA”) for CUTX-101 (Copper Histidinate) for the treatment of Menkes disease, a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A. The NDA has been granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2025. In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical compa
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News
- Sentynl Therapeutics Announces U.S. FDA Acceptance and Priority Review of New Drug Application for CUTX-101 (Copper Histidinate) Product Candidate for Treatment of Menkes Disease [Yahoo! Finance]Yahoo! Finance
- Sentynl Therapeutics Announces U.S. FDA Acceptance and Priority Review of New Drug Application for CUTX-101 (Copper Histidinate) Product Candidate for Treatment of Menkes DiseasePR Newswire
- Fortress Biotech, Inc. (NASDAQ: FBIO) had its price target raised by analysts at HC Wainwright from $24.00 to $26.00. They now have a "buy" rating on the stock.MarketBeat
- Fortress Biotech Third Quarter 2024 Earnings: Misses Expectations [Yahoo! Finance]Yahoo! Finance
- Fortress Biotech, Inc. (NASDAQ: FBIO) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
FBIO
Earnings
- 11/14/24 - Miss
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Sec Filings
- 1/6/25 - Form 8-K
- 1/3/25 - Form 4
- 1/3/25 - Form 4
- FBIO's page on the SEC website