Grace Therapeutics Announces Abstract Highlighting STRIVE-ON Phase 3 Trial Results Accepted for Presentation at AAN 2026
Rhea-AI Summary
Grace Therapeutics (Nasdaq: GRCE) announced that an abstract reporting results from its STRIVE-ON Phase 3 safety trial of GTX-104 (nimodipine IV) was accepted for presentation at the American Academy of Neurology annual meeting, April 18-22, 2026.
The STRIVE-ON results will appear as a poster on April 21, 2026 at 1:00 pm CT in Session S21: Neurocritical Care, titled "Safety and Tolerability of GTX-104 Compared with Oral Nimodipine".
AI-generated analysis. Not financial advice.
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News Market Reaction – GRCE
On the day this news was published, GRCE gained 12.04%, reflecting a significant positive market reaction. Argus tracked a peak move of +18.8% during that session. Our momentum scanner triggered 19 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $8M to the company's valuation, bringing the market cap to $73.50M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
GRCE is up 6.41% while momentum scanner shows peer VRCA moving down (-6.41%) with no same-direction peers flagged, indicating a stock-specific move rather than a sector-wide rotation.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Oct 23 | Warrant exercises | Positive | +1.9% | Raised $4.0M via warrant exercises tied to GTx-104 NDA acceptance. |
| Sep 22 | Trial presentation | Positive | +0.3% | Presented pivotal Phase 3 STRIVE-ON safety trial results at major meeting. |
| Aug 27 | NDA acceptance | Positive | -4.5% | FDA accepted NDA for GTx-104 with defined PDUFA review timeline. |
| Feb 10 | Phase 3 results | Positive | +8.3% | Phase 3 STRIVE-ON trial met primary safety endpoint with favorable outcomes. |
Clinical trial and NDA-related updates have generally led to modest positive reactions, with one notable selloff despite positive news.
Recent history centers on GTx-104 and its Phase 3 STRIVE-ON safety data. Positive results in Feb 2025 and subsequent NDA acceptance, warrant exercises, and scientific presentations built a consistent narrative of progress in aSAH. Shares typically moved a few percent on these clinical updates. Today’s AAN 2026 presentation acceptance continues this pattern of data dissemination from the same pivotal trial, reinforcing the ongoing regulatory and medical community visibility for GTx-104.
Historical Comparison
Past clinical-trial news for GTx-104 produced average moves of about 1.52%. Today’s additional STRIVE-ON Phase 3 exposure at AAN 2026 fits this pattern of data-driven, trial-focused catalysts.
Clinical milestones progressed from Phase 3 STRIVE-ON results to FDA NDA acceptance, followed by warrant-funded strengthening of the balance sheet and repeated scientific presentations of the same pivotal data.
Market Pulse Summary
The stock surged +12.0% in the session following this news. A strong positive reaction aligns with the company’s history of constructive responses to major GTx-104 milestones. Prior clinical-trial announcements around STRIVE-ON often led to modest gains, and this AAN 2026 presentation extends that trajectory of growing scientific visibility. Investors reviewing this move may weigh how repeated, favorable data disclosures and the approaching April 23, 2026 PDUFA date interact with existing expectations and prior price responses.
Key Terms
aneurysmal subarachnoid hemorrhage medical
nimodipine medical
intravenous infusion medical
Phase 3 medical
randomized trial medical
AI-generated analysis. Not financial advice.
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.
The STRIVE-ON Trial results will be presented as a poster on April 21, 2026. Details are as follows:
| Session: | S21: Neurocritical Care | |
| Date: | April 21, 2026 | |
| Time: | 1:00 pm CT | |
| Title: | Safety and Tolerability of GTX-104 (Nimodipine Injection for IV Infusion) Compared with Oral Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage: a Prospective, Randomized Trial | |
About the STRIVE-ON Trial
The STRIVE-ON trial (NCT05995405) was a prospective, randomized open-label trial of GTx-104 compared with oral nimodipine in patients hospitalized with aSAH. 50 patients were administered GTx-104 and 52 patients received oral nimodipine. The primary endpoint was the number of patients with at least one episode of clinically significant hypotension reasonably considered to be caused by the drug, and additional secondary endpoints included safety, clinical, and pharmacoeconomic outcomes. The trial met its primary endpoint, with patients receiving GTx-104 observed to have a
About aneurysmal Subarachnoid Hemorrhage (aSAH)
aSAH is bleeding over the surface of the brain in the subarachnoid space between the brain and the skull, which contains blood vessels that supply the brain. A primary cause of such bleeding is the rupture of an aneurysm in the brain. The result is a relatively uncommon type of stroke (aSAH) that accounts for about
About GTx-104
GTx-104 is a clinical stage, novel, injectable formulation of nimodipine being developed for IV infusion in aSAH patients to address significant unmet medical needs. The unique nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. GTx-104 provides a convenient IV delivery of nimodipine in the Intensive Care Unit potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. Intravenous delivery of GTx-104 also has the potential to lower food effects, drug-to-drug interactions, and eliminate potential dosing errors. Further, GTx-104 has the potential to better manage hypotension in aSAH patients. GTx-104 has been administered in over 200 patients and healthy volunteers and was well tolerated with significantly lower inter- and intra-subject pharmacokinetic variability compared to oral nimodipine.
About Grace Therapeutics
Grace Therapeutics, Inc. (Grace Therapeutics or the Company) is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Grace Therapeutics’ novel drug delivery technologies have the potential to improve the performance of currently marketed drugs by achieving faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery. Grace Therapeutic’s lead clinical assets have each been granted Orphan Drug Designation by the Food and Drug Administration (FDA), which provides seven years of marketing exclusivity post-launch in the United States if certain conditions are met at New Drug Application (NDA) approval, and additional intellectual property protection with over 40 granted and pending patents. Grace Therapeutics’ lead clinical asset, GTx-104, is an IV infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull.
Forward-Looking Statements
Statements in this press release that are not statements of historical or current fact constitute “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and “forward-looking information” within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Such forward-looking statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Grace Therapeutics to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements containing the terms “believes,” “belief,” “expects,” “intends,” “anticipates,” “estimates,” “potential,” “should,” “may,” “will,” “plans,” “continue,” “targeted” or other similar expressions to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The forward-looking statements in this press release, including statements regarding, GTx-104’s potential to bring enhanced treatment options to patients suffering from aSAH, GTx-104’s potential to be administered to improve the management of hypotension in patients with aSAH, gastrointestinal intolerance and dosing consistency compared with oral administration, the ability of GTx-104 to achieve a pharmacokinetic and safety profile similar to the oral form of nimodipine, and GTx-104’s potential to achieve medical and pharmacoeconomic benefit, are based upon Grace Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation: (i) the success of regulatory submissions of the Phase 3 STRIVE-ON safety trial for GTx-104; (ii) regulatory requirements or developments and the outcome of the Company’s NDA submission for GTx-104; (iii) changes to regulatory pathways; (iv) our ability to protect our intellectual property for our drug candidates; and (v) legislative, regulatory, political and economic developments. The foregoing list of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors detailed in the “Special Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2025, the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025, the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2025 and the Company’s Quarterly Report on Form 10-Q for the quarterly period ended December 31, 2025, filed with the Securities and Exchange Commission (SEC) and other documents that have been and will be filed by Grace Therapeutics from time to time with the SEC and Canadian securities regulators. All forward-looking statements contained in this press release speak only as of the date on which they were made. Grace Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by applicable securities laws.
For more information, please visit: www.gracetx.com
For more information, please contact:
Grace Therapeutics Contact:
Prashant Kohli
Chief Executive Officer
Tel: 609-322-1602
Email: info@gracetx.com
www.gracetx.com
Investor Relations:
LifeSci Advisors
Mike Moyer
Managing Director
Phone: 617-308-4306
Email: mmoyer@lifesciadvisors.com