Menkes Disease Epidemiology Forecast Research 2020-2034: Increase in Diagnosed Prevalence, Driven by Enhanced Genetic Testing and Awareness
The "Menkes Disease - Epidemiology Forecast - 2034" report has been added to ResearchAndMarkets.com's offering.Menkes Disease is an X-linked recessive disorder characterized by a decline in ...
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FDA accepts Sentynl’s Menkes disease therapy NDA for priority review
The US Food and Drug Administration (FDA) has accepted for filing and priority review of the new drug application (NDA) for Sentynl Therapeutics' CUTX-101 (copper histidinate) for the treatment of ...
The Business Journals1mon
Drug to treat rare pediatric disease accepted for FDA review
There is currently no cure of FDA-approved treatment for the disease. STORY HIGHLIGHTS FDA accepted Cyprium Therapeutics' CUTX-101 drug application. CUTX-101 treats Menkes disease, a rare genetic ...
Endocrinology Advisor2d
January 2025 Recap: Drug Pipeline Updates
The table below is a review of notable updates that occurred in January 2025 for investigational products in development.
Nasdaq1mon
FDA Grants Priority Review For Sentynl's CUTX-101 For Menkes Disease
(RTTNews) - Sentynl Therapeutics and Fortress Biotech, Inc. (FBIO), a biopharmaceutical company, on Monday, announced that the U.S. Food and Drug Administration has accepted for filing and granted ...
manilatimes1mon
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
The CUTX-101 NDA submission is supported by positive topline clinical efficacy results for CUTX-101, demonstrating statistically significant improvement in overall survival for Menkes disease subjects ...
Monthly Prescribing Reference8d
January 2025 Recap: Drug Pipeline Updates
Complete Response Letter issued CUTX-101 (copper histidinate; Fortress Biotech and Cyprium Therapeutics) Copper replacement therapy Treatment of Menkes disease. Accepted for Priority Review ...