Sentynl Therapeutics Announces U.S. FDA Acceptance and Priority Review of New Drug Application for CUTX-101 (Copper Histidinate) Product Candidate for Treatment of Menkes Disease
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Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, announced that the FDA has accepted and granted priority review for their new drug application for CUTX-101, a potential treatment for Menkes disease. The PDUFA target action date is set for June 30, 2025.
January 06, 2025 | 1:15 pm
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Sentynl Therapeutics, owned by Zydus Lifesciences, has received FDA priority review for CUTX-101, a potential treatment for Menkes disease. This could be the first FDA-approved treatment for this rare disease, with a PDUFA date set for June 30, 2025.
The FDA's acceptance and priority review of CUTX-101 is a significant milestone for Sentynl Therapeutics, indicating strong potential for approval. This could lead to increased investor interest and a positive impact on the stock price of FBIO, as Sentynl is a subsidiary of Zydus Lifesciences.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80