Business
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
NEW YORK and SOLANA BEACH, Calif., Dec. 07, 2021 (GLOBE NEWSWIRE) -- Cyprium Therapeutics, Inc. (“Cyprium”), a Fortress Biotech, Inc. (Nasdaq: FBIO)
About this update from Fortress Biotech, Inc.
[{"type":"text","content":"NEW YORK and SOLANA BEACH, Calif., Dec. 07, 2021 (GLOBE NEWSWIRE) -- 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 New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for CUTX-101 (“Copper Histidinate”) for the treatment of Menkes disease. The companies expect to complete the submission of the NDA to the FDA in mid-2022. In October 2021, Cyprium announced positive results from a safety and efficacy analysis of data integrated from two completed pivotal studies in patients with Menkes disease treated with CUTX-101. These data were presented as a virtual poster at the recent 2021 American Academy of Pediatrics National Conference & Exhibition. CUTX-101 was previously granted FDA Breakthrough Therapy, Fast Track, Rare Pediatric Disease and FDA Orphan Drug Designations. Additionally, the European Medicines Agency previously granted Orphan Drug Designation for CUTX-101. “We are very pleased to have initiated the rolling submission of our NDA to the FDA for CUTX-101, an important milestone for Cyprium. In clinical trials, CUTX-101 was well tolerated and demonstrated a clinically meaningful efficacy profile and has the potential to be the first FDA-approved treatment for Menkes disease. If approved, CUTX-101 will fill a significant unmet need for children suffering from this rare, fatal pediatric disease,” said Lung S. Yam, M.D., Ph.D., President and Chief Executive Officer of Cyprium. Stephen G. Kaler, M.D., M.P.H., a physician-scientist at the Center for Gene Therapy in the Abigail Wexner Research Institute at Nationwide Children’s Hospital, Principal Investigator of the clinical trials and professor of Pediatrics and Genetics at The Ohio State University College of Medicine, said, “I am extremely grateful to the teams at Cyprium and Fortress that prepared and initiated this rolling submission. We especially thank the devoted parents of Menkes disease patients who participated in the clinical studies summarized in this NDA, which represents a major step in the battle against this illness.” Earlier this year, Sentynl and Cyprium executed an ass...