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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
FBIOFortress Biotech(FBIO) Prnewswire·2025-01-06 13:00

Six-month priority review granted for CUTX-101 copper histidinate with PDUFA target action date set for June 30, 2025CUTX-101 has potential to be the first FDA-approved treatment for Menkes disease, a rare and fatal pediatric diseaseSOLANA 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") annou ...