FDA Issued Complete Response Letter Citing Outstanding Items Related to Chemistry, Manufacturing, and Controls and Non-Clinical Information 

FDA Does not Request Additional Clinical Data

Company Intends to Resubmit Application Following Resolution of Cited Items

PRINCETON, N.J., April 23, 2026 (GLOBE NEWSWIRE) -- Grace Therapeutics, Inc. (NASDAQ:GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for intravenous infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company's New Drug Application (NDA) for GTx-104 for the treatment of patients with aSAH.

In its CRL, the FDA referenced certain items in the Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections of the application, which Grace believes it can address in a resubmission of its NDA. The cited items are related to leachables data for product packaging, non-clinical product toxicology risk assessments, and product manufacturing deficiencies at our contract manufacturing organization. The Company intends to request a Type A meeting with the FDA to clarify the path forward and determine the appropriate next steps.