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Grace Therapeutics Announces Abstract Highlighting STRIVE-ON Phase 3 Trial Results Accepted for Presentation at AAN 2026

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Rhea-AI Sentiment
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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".

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AI-generated analysis. Not financial advice.

Positive

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News Market Reaction – GRCE

+12.04%
19 alerts
+12.04% News Effect
+18.8% Peak in 25 hr 31 min
+$8M Valuation Impact
$73.50M Market Cap
0.5x Rel. Volume

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

Trial size: 102 patients Hypotension reduction: 19% reduction Hypotension rates: 28% vs 35% +5 more
8 metrics
Trial size 102 patients Phase 3 STRIVE-ON safety trial for GTx-104 in aSAH
Hypotension reduction 19% reduction Clinically significant hypotension vs oral nimodipine (28% vs 35%)
Hypotension rates 28% vs 35% Clinically significant hypotension: GTx-104 vs oral nimodipine
Dose intensity 54% vs 8% Patients achieving ≥95% relative dose intensity, GTx-104 vs oral
Favorable outcomes 29% relative increase Increase in favorable 90-day outcomes for GTx-104 arm
PDUFA date April 23, 2026 FDA review deadline for GTx-104 NDA in aSAH
Warrant proceeds $4.0 million Raised through common warrant exercises after NDA acceptance
Orphan exclusivity 7 years U.S. market exclusivity for GTx-104 if approved

Market Reality Check

Price: $2.57 Vol: Volume 568,386 is below 2...
low vol
$2.57 Last Close
Volume Volume 568,386 is below 20-day average of 866,276 (relative volume 0.66). low
Technical Price 3.82 is trading above the 200-day MA of 3.42.

Peers on Argus

GRCE is up 6.41% while momentum scanner shows peer VRCA moving down (-6.41%) wit...
1 Down

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

4 past events · Latest: Oct 23 (Positive)
Same Type Pattern 4 events
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.
Pattern Detected

Clinical trial and NDA-related updates have generally led to modest positive reactions, with one notable selloff despite positive news.

Recent Company History

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

+1.5% avg move · Past clinical-trial news for GTx-104 produced average moves of about 1.52%. Today’s additional STRIV...
clinical trial
+1.5%
Average Historical Move clinical trial

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 t...
Analysis

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, nimodipine, intravenous infusion, Phase 3, +1 more
5 terms
aneurysmal subarachnoid hemorrhage medical
"to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients"
Aneurysmal subarachnoid hemorrhage is bleeding into the thin space surrounding the brain caused when a weakened blood vessel balloon (an aneurysm) bursts. Like a burst pipe leaking into a narrow hallway, it can cause sudden, severe damage and often requires urgent surgery or devices and long hospital care. For investors, its frequency, treatment options, and outcomes influence demand for medical devices, drugs, hospital services, clinical trial results and health-care spending.
nimodipine medical
"novel, injectable formulation of nimodipine being developed for intravenous infusion"
Nimodipine is a medicine that helps keep small arteries in the brain open after bleeding in the brain, improving blood flow and lowering the risk of further brain damage. For investors, nimodipine matters because regulatory approvals, clinical trial results, patent status, and safety records determine whether a company can sell it widely or add it to a product line, which affects revenue and risk—think of it as a key product in a company's medical toolbox.
intravenous infusion medical
"nimodipine being developed for intravenous infusion to address significant unmet medical needs"
Intravenous infusion is the delivery of fluids, medications or nutrients directly into a vein over a controlled period using tubing and often a pump—like giving a plant a slow, steady watering instead of one big splash. It matters to investors because many hospital treatments and advanced drugs must be made, tested and billed for this form of use; that affects production complexity, clinical trial design, regulatory approval and potential revenue.
Phase 3 medical
"results from the Company’s STRIVE-ON Phase 3 Safety Trial has been accepted"
Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.
randomized trial medical
"a Prospective, Randomized Trial"
A randomized trial is a study where participants are assigned by chance—like flipping a coin—to different treatments or to a comparison group so the results reflect the effect of the treatment rather than other factors. Investors care because these trials provide the most reliable evidence about whether a drug, device, or strategy works, and strong, clear results can change a company’s approval prospects, market size and risk profile quickly.

AI-generated analysis. Not financial advice.

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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 19% reduction in at least one incidence of clinically significant hypotension compared to oral nimodipine (28% versus 35%). Other measures also favored GTx-104 or were comparable between GTx-104 and oral nimodipine, including: 54% patients on GTx-104 had relative dose intensity (RDI) of 95% or higher compared to only 8% on oral nimodipine, and 29% more patients on GTx-104 than on oral nimodipine had favorable functional outcomes at 90 days. In addition, there were fewer intensive care unit (ICU) readmissions, ICU days, and ventilator days for patients receiving GTx-104 versus oral nimodipine. Adverse events were comparable between the two arms and no new safety issues were identified with patients receiving GTx-104. All deaths in both arms of the trial were due to severity of the patient’s underlying disease. There were eight deaths on the GTx-104 arm compared to four deaths on the oral nimodipine arm. The survival status of one patient on the oral nimodipine arm was unknown. No deaths were determined to be related to GTx-104 or oral nimodipine.

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 5% of all strokes and an estimated 42,500 U.S. hospital treated patients.

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


FAQ

When will Grace Therapeutics (GRCE) present STRIVE-ON Phase 3 results at AAN 2026?

The STRIVE-ON Phase 3 poster will be presented on April 21, 2026 at 1:00 pm CT. According to the company, presentation details list Session S21: Neurocritical Care and a poster-format display.

What does the AAN 2026 poster for GRCE's GTX-104 cover?

The poster covers safety and tolerability of GTX-104 versus oral nimodipine in aSAH patients. According to the company, it reports results from the STRIVE-ON prospective, randomized Phase 3 safety trial.

Where and in which session will GRCE present the STRIVE-ON data at AAN 2026?

GRCE will present in Chicago, IL, Session S21: Neurocritical Care on April 21, 2026. According to the company, the poster is scheduled at 1:00 pm CT during the AAN annual meeting.

What is the STRIVE-ON trial that Grace Therapeutics (GRCE) is presenting?

STRIVE-ON is a Phase 3, prospective, randomized safety trial comparing GTX-104 IV nimodipine with oral nimodipine in aSAH patients. According to the company, the abstract highlights safety and tolerability findings.

How can investors find GRCE's STRIVE-ON poster results after AAN 2026?

The poster will be presented publicly on April 21, 2026; attendees can view details at the session. According to the company, the abstract acceptance indicates planned dissemination at the AAN meeting and likely subsequent public materials.