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Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
Monday, 6th January at 8:00 am
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 company wholly-owned by Zydus Lifesciences, Ltd. ("Zydus Group"), assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium. The NDA submission was completed by Sentynl who will be responsible for commercialization upon approval. As described below, Cyprium is eligible to receive royalties and retains ownership of any Priority Review Voucher that may be issued.
Monday, 6th January at 8:00 am
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 company wholly-owned by Zydus Lifesciences, Ltd. ("Zydus Group"), assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium. The NDA submission was completed by Sentynl who will be responsible for commercialization upon approval. As described below, Cyprium is eligible to receive royalties and retains ownership of any Priority Review Voucher that may be issued.
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