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FDA issues complete response letter for Grace Therapeutics’ GTx-104 NDA

PUBT·04/23/2026 17:13:46
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FDA issues complete response letter for Grace Therapeutics’ GTx-104 NDA
  • FDA issued Complete Response Letter for Grace Therapeutics NDA for GTx-104 in aneurysmal subarachnoid hemorrhage.
  • Letter cited outstanding items in Chemistry, Manufacturing, and Controls plus non-clinical information.
  • Agency did not request additional clinical data.
  • Grace plans to seek FDA Type A meeting to clarify path to resubmission.
  • Resubmission expected to address packaging leachables, toxicology risk assessments, manufacturing deficiencies at contract manufacturer.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Grace Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202604231313PRIMZONEFULLFEED9696020) on April 23, 2026, and is solely responsible for the information contained therein.