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! F...
Fortress Biotech, Inc. (FBIO)
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Source: Yahoo! Finance
CUTX-101 has potential to be the first FDA-approved treatment for Menkes disease, a rare and fatal pediatric disease SOLANA BEACH, Calif. and AHMEDABAD, India and MIAMI Jan. 6, 2025 /PRNewswire/ -- Sentynl Therapeutics, Inc. ("Sentynl"), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. ("Zydus Group"), and Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress") announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and Priority review Sentynl's New Drug Application (NDA) for CUTX-101, the product candidate for the treatment of Menkes disease. Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A. Recent estimates suggest a prevalence of 1 in 34,810 to as high as 1 in 8,664 live male births. Sentynl Therapeutics, Inc. (PRNewsfoto/Sentynl Therapeutics) Sentynl's NDA is supported by positive topline clinical efficacy results for CUTX-101, demonstrating statistical
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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 DiseasePR Newswire
- Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes DiseaseGlobeNewswire
- 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
FBIO
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