Grace Therapeutics Announces 2026 Fiscal Year-End Financial Results, Provides Business Update

Type A Meeting Scheduled with FDA to Potentially Clarify Path to GTx-104 NDA Resubmission Phase 3 STRIVE-ON Safety Trial Data Presented at Multiple Medical Conferences Company Continues Disciplined Pre-Commercial Planning in Anticipation of Potential FDA Approval of NDA Resubmission for GTx-104 for the Treatment of Patients with aSAH PRINCETON, N.J., June 18, 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 IV infusion to address significant unmet medical needs in aSAH patients, today announced the financial results and business highlights for the fiscal year ended March 31, 2026. "Since receipt of the U.S. Food and Drug Administration's (FDA) Complete Response Letter (CRL) in April 2026, we have been working diligently on addressing the cited items, and we look forward to a constructive discussion with the FDA as we continue to prepare our resubmission," said Prashant Kohli, CEO of Grace Therapeutics. "FDA approval of our New Drug Application (NDA) for GTx-104 for the treatment of aSAH would represent the first meaningful innovation in the standard of care for these patients in more than 40 years. As evidenced by the response among researchers, practitioners and industry leaders to the presentation of our Phase 3 STRIVE-ON trial results at major medical conferences throughout the fiscal year, we believe there is a significant desire in the marketplace for an intravenously administered nimodipine. We are confident in the robust data package supporting our NDA, and that the issues identified by the FDA can be successfully addressed in our resubmission." Fiscal 2026 and Recent Corporate Highlights On April 23, 2026, the FDA issued a CRL for the Company's NDA for GTx-104 for th