GRCE

FDA Did Not Identify Any Clinical Safety or Efficacy Deficiencies and Did Not Request Additional Clinical Data Company Advancing a Dual-Source Manufacturing Strategy, Adding a U.S.-Based Site, Toward NDA Resubmission PRINCETON, N.J., July 28, 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 receipt of the U.S. Food and Drug Administration (FDA) meeting minutes from a Type A Meeting held with the FDA to discuss the Complete Response Letter (CRL) issued on April 23, 2026.

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.

LOS ANGELES, June 11, 2026 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Grace Therapeutics, Inc. ("Grace" or "the Company") (NASDAQ: GRCE) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

LOS ANGELES, June 8, 2026 /PRNewswire/ -- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Grace Therapeutics, Inc. ("Grace" or "the Company") (NASDAQ: GRCE) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors.

ATLANTA, June 03, 2026 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Grace Therapeutics, Inc. (“Grace Therapeutics” or the “Company”) (NASDAQ: GRCE) complied with federal securities laws. On April 23, 2026, Grace Therapeutics announced the FDA issued a Complete Response Letter (“CRL”) for the Company's New Drug Application for GTx-104 revealing that the CRL referenced certain items “related to leachables data for product packaging, non-clinical product toxicology risk assessments, and product manufacturing deficiencies at our contract manufacturing organization.” The price of the Company's stock dropped following this news.

Grace Therapeutics is rated a Speculative Buy with a $4 price target, implying 57% upside after a sharp drop from a CMC-only FDA CRL. The FDA's concerns for GTx-104 are limited to fixable chemistry, manufacturing, and controls issues, with no efficacy or safety objections raised. A scenario-weighted DCF model assigns a 75% probability of approval, forecasting $100M peak risk-adjusted U.S. sales and highlighting a favorable risk/reward profile.

LOS ANGELES--(BUSINESS WIRE)---- $GRCE--GRCE Investors Have Opportunity to Join Grace Therapeutics, Inc. Fraud Investigation with the Schall Law Firm.

NEW YORK, May 21, 2026 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Grace Therapeutics, Inc. ("Grace" or the "Company") (NASDAQ: GRCE). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.

NEW YORK, May 14, 2026 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Grace Therapeutics, Inc. ("Grace" or the "Company") (NASDAQ: GRCE). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.

Grace Therapeutics Inc. (NASDAQ:GRCE) shares are down during Friday's premarket session following a regulatory update regarding its New Drug Application (NDA) for GTx-104.