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Fortress Biotech, Cyprium Therapeutics and Sentynl Therapeutics Announce CUTX-101, Copper Histidinate, Data to be Presented at 2022 American College of Medical Genetics Annual Clinical Genetics Meeting

Download PDF Cyprium Therapeutics, a subsidiry of Fortress Biotech, is developing CUTX-101 for the treatment of Menkes disease CUTX-101 has potential to be first FDA-approved treatment for Menkes disease; rolling submission of New Drug Application to FDA is ongoing and expected to be completed in mid-year 2022 Miami, FL, and Solana Beach, CA, March 21, … Continue reading “Fortress Biotech, Cyprium Therapeutics and Sentynl Therapeutics Announce CUTX-101, Copper Histidinate, Data to be Presented at 2022 American College of Medical Genetics Annual Clinical Genetics Meeting”

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”

Fortress Biotech Announces Positive Topline Clinical Efficacy Results for CUTX-101, Copper Histidinate, for the Treatment of Menkes Disease

Fortress Biotech Announces Positive Topline Clinical Efficacy Results for CUTX-101, Copper Histidinate, for the Treatment of Menkes Disease Statistically Significant Improvement in the Primary Endpoint of Overall Survival in Menkes Disease Patients who Received Early Treatment with CUTX-101, Compared to an Untreated Historical Control, with a Nearly 80% Reduction in the Risk of Death (Hazard … Continue reading “Fortress Biotech Announces Positive Topline Clinical Efficacy Results for CUTX-101, Copper Histidinate, for the Treatment of Menkes Disease”

Fortress Biotech Announces Positive Opinion on Orphan Drug Designation Received from the European Medicines Agency for CUTX-101, Copper Histidinate, for the Treatment of Menkes Disease

Fortress Biotech Announces Positive Opinion on Orphan Drug Designation Received from the European Medicines Agency 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 fourth quarter of 2020 Download PDF New York, NY, July 31, 2020 – … Continue reading “Fortress Biotech Announces Positive Opinion on Orphan Drug Designation Received from the European Medicines Agency for CUTX-101, Copper Histidinate, for the Treatment of Menkes Disease”

Fortress Biotech Announces Publication of Study on Targeted Next Generation Sequencing for Newborn Screening of Menkes Disease in Molecular Genetics and Metabolism Reports

Fortress Biotech Announces Publication of Study on Targeted Next Generation Sequencing for Newborn Screening of Menkes Disease in Molecular Genetics and Metabolism Reports Cyprium Therapeutics, a Fortress partner company, is developing CUTX-101 for Menkes disease A rolling submission of a New Drug Application to the FDA is expected to begin in the fourth quarter of … Continue reading “Fortress Biotech Announces Publication of Study on Targeted Next Generation Sequencing for Newborn Screening of Menkes Disease in Molecular Genetics and Metabolism Reports”

Fortress Biotech Announces Publication of Study on Estimated Birth Prevalence of Menkes Disease in Molecular Genetics and Metabolism Reports

Fortress Biotech Announces Publication of Study on Estimated Birth Prevalence of Menkes Disease in Molecular Genetics and Metabolism Reports Cyprium Therapeutics, a Fortress partner company, is developing CUTX-101 for Menkes disease and is on track to begin submitting a rolling New Drug Application to the FDA in the fourth quarter of 2020 Download PDF New … Continue reading “Fortress Biotech Announces Publication of Study on Estimated Birth Prevalence of Menkes Disease in Molecular Genetics and Metabolism Reports”

Fortress Biotech Announces Rare Pediatric Disease Designation for CUTX-101 for the Treatment of Menkes Disease

FORTRESS BIOTECH ANNOUNCES RARE PEDIATRIC DISEASE DESIGNATION FOR CUTX-101 FOR THE TREATMENT OF MENKES DISEASE Cyprium Therapeutics, a Fortress partner company, on track to begin submitting rolling New Drug Application for CUTX-101 to the FDA in the second half of 2020 Download PDF NEW YORK, NY – JANUARY 16, 2020 – Fortress Biotech, Inc. (Nasdaq: … Continue reading “Fortress Biotech Announces Rare Pediatric Disease Designation for CUTX-101 for the Treatment of Menkes Disease”