Grace Therapeutics

GRCE

Market cap $37M

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 19, 2026 (GLOBE NEWSWIRE) -- 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. 7980.

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.

Grace ​Therapeutics said ‌on ​Thursday ​the U.S. ⁠Food ​and Drug ​Administration declined ​to ​approve its drug ‌for ⁠a rare ​type ​of ⁠stroke.

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

PRINCETON, N.J., April 14, 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 an abstract highlighting the results from the Company's STRIVE-ON Phase 3 Safety Trial has been accepted for presentation at the upcoming  2026 American Academy of Neurology annual meeting, to be held April 18-22, 2026 in Chicago, IL.