Brief: Grace Therapeutics Says FDA Issued Complete Response Letter For GTx-104 NDA
23/04/2026 18:25
April 23 (Reuters) - Grace Therapeutics, Inc GRCE.O: GRACE THERAPEUTICS PROVIDES REGULATORY UPDATE ON NEW DRUG APPLICATION FOR GTX-104 GRACE THERAPEUTICS, INC - FDA ISSUES COMPLETE RESPONSE LETTER FOR GTX-104 NDA GRACE THERAPEUTICS, INC: COMPANY INTENDS TO RESUBMIT APPLICATION FOLLOWING RESOLUTION OF CITED ITEMS GRACE THERAPEUTICS, INC - TO REQUEST TYPE A MEETING WITH FDA FOR GTX-104 NDA GRACE THERAPEUTICS, INC - FDA DOES NOT REQUEST ADDITIONAL CLINICAL DATA FOR GTX-104 NDA GRACE THERAPEUTICS, INC - CITED ITEMS INCLUDE LEACHABLES DATA, TOXICOLOGY ASSESSMENTS, MANUFACTURING DEFICIENCIES FOR GTX-104 Source text: ID:nGNX8GnY9f Further company coverage: GRCE.O ((Reuters.Briefs@thomsonreuters.com;))
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