Zydus Lifesciences rose 1.22% to Rs 974.75 after its wholly-owned subsidiary, Sentynl Therapeutics, and Fortress Biotech said that U.S. food and Drug Administration has accepted filing and priority review Sentynl's new drug application for CUTX-101.
The said product is for the treatment of Menkes disease. Sentynls NDA is supported by positive topline clinical efficacy results for CUTX-101, demonstrating statistically significant improvement in overall survival for Menkes disease subjects who received early treatment with CUTX-101, with a nearly 80% reduction in the risk of death compared to an untreated historical control cohort. Median overall survival was 177.1 months for the CUTX-101 early treatment cohort compared to 16.1 months for the untreated historical control cohort.Punit Patel, president & CEO, Zydus Americas, The NDA acceptance of CUTX-101 marks an important step towards our vision to transform lives and meaningfully impact patients, caregivers, and the rare disease community at large. We remain committed to providing access to path-breaking discoveries that can address unmet needs globally, as evident in the potential impact of CUTX-101 on Menkes disease patients and their families.
Matt Heck, president & CEO, Sentynl, Menkes disease presents a difficult journey for patients and their caregivers, as ATP7A mutations impact the transport of copper to a range of organs and systems, such as the lungs, brain and heart. With no known cure or current FDA-approved treatments, death typically occurs between 2 to 3 years of age. We are eager for the FDA to review our application for CUTX-101, which has the potential to be the first FDA-approved therapy for this devastating condition.
Lindsay A. Rosenwald, M.D, chairman, president and chief executive officer, Fortress and Chairmanof Cyprium, We congratulate Sentynl on the NDA acceptance for filing and review of CUTX-101, a program that Cyprium advanced and proudly supports, The drug has a demonstrated safety and efficacy profile for the treatment of Menkes disease and, if approved, CUTX-101 will fill a significant unmet need for children suffering from this rare, fatal pediatric disease.
Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The companys consolidated net profit increased 13.8% to Rs 911.20 crore in Q2 FY25 as against Rs 800.70 crore posted in Q2 FY24. Revenue from operations jumped 20.1% to Rs 5,113.60 crore in the quarter ended 30 September 2024.
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