23 April 2026 - Grace Therapeutics today announced that the US FDA has issued a complete response letter for the Company’s new drug application for GTx-104 for the treatment of patients with aneurysmal subarachnoid haemorrhage.

In its complete response letter, the FDA referenced certain items in the Chemistry, Manufacturing, and Controls and Non-Clinical sections of the application, which Grace believes it can address in a resubmission of its new drug application.

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