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Grace Therapeutics Stock Falls as Fda Declines to Approve Brain Hemorrhage Drug - Grace Therapeutics (Nas

Summary by Benzinga
Grace Therapeutics stock drops after FDA flags NDA issues for GTx-104; CMC concerns weigh despite no request for additional clinical data. Importance Rank:  1

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Grace Therapeutics Stock Falls as Fda Declines to Approve Brain Hemorrhage Drug - Grace Therapeutics (Nas

Grace Therapeutics stock drops after FDA flags NDA issues for GTx-104; CMC concerns weigh despite no request for additional clinical data. Importance Rank:  1

·New York, United States
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mykxlg.commykxlg.com

Grace Therapeutics Provides Regulatory Update on New Drug Application for GTx-104

FDA Issued Complete Response Letter Citing Outstanding Items Related to Chemistry, Manufacturing, and Controls and

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stocktitan.netstocktitan.net

FDA sends Grace drug application back over manufacturing issues

Agency cited packaging leachables, toxicology assessments and CMO deficiencies. Grace plans a Type A FDA meeting before resubmitting.

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stocktitan.net broke the news on Thursday, April 23, 2026.
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