Author: jjaffe

Fortress Biotech and Cyprium Therapeutics Announce $4.1 Million Grant from NINDS to Further Development of AAV-ATP7A Gene Therapy for Menkes Disease

Download PDF Encouraging preclinical studies demonstrate potential to combine AAV-ATP7A gene therapy with CUTX-101, which could be the first FDA-approved treatment for Menkes disease Cyprium Therapeutics, a majority-owned subsidiary of Fortress Biotech, is developing AAV-ATP7A gene therapy to be used in conjunction with CUTX-101 for the treatment of Menkes disease Miami, FL,  March 4, 2024 … Continue reading “Fortress Biotech and Cyprium Therapeutics Announce $4.1 Million Grant from NINDS to Further Development of AAV-ATP7A Gene Therapy for Menkes Disease”

Cyprium Therapeutics, a Fortress Biotech Subsidiary Company, Completes Asset Transfer of CUTX-101 Copper Histidinate Product Candidate for Treatment of Menkes Disease, to Sentynl Therapeutics, a Wholly-owned Subsidiary of Zydus Lifesciences Ltd.

Download PDF Cyprium received $4.5 million payment upon closing and remains eligible to receive royalties and up to $129 million in aggregate development and sales milestones Cyprium will retain 100% ownership over any FDA priority review voucher that may be issued at NDA approval for CUTX-101 Miami, FL, December 6, 2023 – Cyprium Therapeutics, Inc. … Continue reading “Cyprium Therapeutics, a Fortress Biotech Subsidiary Company, Completes Asset Transfer of CUTX-101 Copper Histidinate Product Candidate for Treatment of Menkes Disease, to Sentynl Therapeutics, a Wholly-owned Subsidiary of Zydus Lifesciences Ltd.”

Fortress Biotech, Cyprium Therapeutics and Sentynl Therapeutics Announce the Initiation of Rolling Submission of a New Drug Application for CUTX-101, Copper Histidinate, for Treatment of Menkes Disease

Download PDF New York, NY, and Solana Beach, CA, December 7, 2021 – Cyprium Therapeutics, Inc. (“Cyprium”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) partner company, with support from its licensing partner Sentynl Therapeutics, Inc. (“Sentynl”), a wholly owned subsidiary of Cadila Healthcare Limited (“Zydus”), today announced the initiation of a rolling submission of a … Continue reading “Fortress Biotech, Cyprium Therapeutics and Sentynl Therapeutics Announce the Initiation of Rolling Submission of a New Drug Application for CUTX-101, Copper Histidinate, for Treatment of Menkes Disease”

Fortress Biotech and Cyprium Therapeutics Announce Positive Clinical Data for CUTX-101, Copper Histidinate, Presented at 2021 American Academy of Pediatrics National Conference & Exhibition

Download PDF Cyprium Therapeutics, a partner company of Fortress Biotech, is developing CUTX-101 for the treatment of Menkes disease Overall survival significantly improved in patients treated with CUTX-101 Rolling submission of New Drug Application to the FDA for CUTX-101 planned to begin in fourth quarter of 2021; potential to be first FDA-approved treatment for Menkes … Continue reading “Fortress Biotech and Cyprium Therapeutics Announce Positive Clinical Data for CUTX-101, Copper Histidinate, Presented at 2021 American Academy of Pediatrics National Conference & Exhibition”

Fortress Biotech Announces Breakthrough Therapy Designation for CUTX-101, Copper Histidinate, for the Treatment of Menkes Disease

Fortress Biotech Announces Breakthrough Therapy Designation for CUTX-101, Copper Histidinate, for the Treatment of Menkes Disease Rolling submission of New Drug Application to the FDA for CUTX-101 on track to begin in the first quarter of 2021 and to be completed by the end of the second quarter of 2021 Download PDF New York, NY, … Continue reading “Fortress Biotech Announces Breakthrough Therapy Designation for CUTX-101, Copper Histidinate, for the Treatment of Menkes Disease”