Grace Therapeutics Announces Receipt of Type A Meeting Minutes from U.S. Food and Drug Administration
Rhea-AI Summary
Grace Therapeutics (Nasdaq: GRCE) received formal Type A meeting minutes from the U.S. FDA regarding the Complete Response Letter (CRL) issued on April 23, 2026 for GTx-104, its IV nimodipine candidate for aneurysmal subarachnoid hemorrhage (aSAH).
The FDA did not identify any clinical safety or efficacy deficiencies for GTx-104 and did not request additional clinical data. Outstanding CRL items focus on cGMP compliance at the current contract manufacturing organization, plus additional leachables data time points and excipient toxicology risk assessments, which the company plans to address with required non-clinical studies.
Grace Therapeutics is advancing a dual-source manufacturing strategy, maintaining its existing manufacturer while transferring technology to a second U.S.-based site to support NDA resubmission. GTx-104’s STRIVE-ON trial met its primary endpoint, showing lower clinically significant hypotension versus oral nimodipine, and has Orphan Drug Designation with potential U.S. market exclusivity.
Positive
- FDA CRL contained no clinical deficiencies and requested no new clinical data for GTx-104
- STRIVE-ON trial met primary endpoint with 19% lower hypotension incidence for GTx-104 vs oral nimodipine (28% vs 35%)
- GTx-104 treatment achieved 54% vs 8% of patients with ≥95% relative dose intensity compared with oral nimodipine
- GTx-104 has FDA Orphan Drug Designation with potential seven years of U.S. marketing exclusivity post-approval
- Over 200 patients and healthy volunteers exposed to GTx-104, reported as well tolerated with lower pharmacokinetic variability than oral capsules
Negative
- FDA Complete Response Letter requires cGMP remediation at the current contract manufacturing organization, including reinspection
- NDA resubmission for GTx-104 depends on completion of additional non-clinical studies and leachables and excipient toxicology assessments
News Explained
The resubmission route is not yet fixed: either the remediated current site, the U.S. second source, or both could support it.
On
The current manufacturer must remediate facility-level cGMP matters and demonstrate inspection readiness before an FDA reinspection can verify that route, while technology transfer to the second source is advancing in parallel.
Because no single resubmission path has been designated, the company’s manufacturing route remains unresolved rather than committed to one site.
The stated next milestones are completion of required non-clinical studies, remediation and FDA reinspection at the current site, second-source technology transfer, and the eventual resubmission.
News Market Reaction – GRCE
In the Jul 28 session, GRCE declined 2.17%, reflecting a moderate negative market reaction. Argus tracked a peak move of +2.3% during that session. Argus tracked a trough of -25.8% from its starting point during tracking. Our momentum scanner triggered 37 alerts that day, indicating elevated trading interest and price volatility. Trading volume was exceptionally heavy at 7.2x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 18 | Fiscal results update | Positive | +7.2% | Reported improved annual loss and regulatory progress for GTx-104 |
| Apr 23 | FDA regulatory setback | Negative | -45.5% | FDA issued a Complete Response Letter citing CMC and manufacturing items |
| Apr 14 | Clinical data presentation | Positive | +12.0% | STRIVE-ON Phase 3 results were accepted for AAN presentation |
| Mar 19 | Conference presentation | Neutral | -1.4% | Company announced presentations on GTx-104 and aSAH treatment needs |
| Feb 25 | Conference participation | Neutral | -1.2% | CEO participation at the TD Cowen healthcare conference was announced |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Positive company updates aligned with gains, the April Complete Response Letter aligned with a sharp decline, and conference notices were followed by declines.
Key Terms
type a meeting regulatory
complete response letter regulatory
cgmp regulatory
nda regulatory
pharmacokinetic variability medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
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. The minutes constitute the official record of the Type A meeting.
As previously disclosed, the CRL did not identify any clinical safety or efficacy deficiencies and did not request additional clinical data. The items cited by the FDA relate to the current good manufacturing practice (cGMP) compliance status of the Company's contract manufacturing organization — a facility-level matter, and not a GTx-104 product-specific quality finding — together with additional leachables data time points and excipient toxicology risk assessments. The Company intends to address each of the CRL items in its planned resubmission, including completing the required non-clinical studies.
As part of that plan, the Company is pursuing a dual-source manufacturing strategy. Its current contract manufacturer is responsible for remediating the cGMP matters identified at its facility and demonstrating inspection readiness, which would ultimately need to be verified through an FDA reinspection. In parallel, the Company is advancing technology transfer to a second-source contract manufacturer located in the United States. This approach gives GTx-104 more than one route to a compliant registration site and reduces reliance on any single manufacturing source. The Company has not designated a single path to resubmission; a resubmission may be supported by either contract manufacturer, or both.
“Following receipt of the FDA’s minutes, we have a clear view of what is required and are executing against it, including advancing a second manufacturing source in the United States so that we are not dependent on a single path to resubmission,” said Prashant Kohli, Chief Executive Officer of Grace Therapeutics. “We will report progress as key milestones are achieved. If approved, GTx-104 would represent a meaningful innovation in the care for aSAH, and we are committed to improving outcomes for aSAH patients.”
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 aSAH, a relatively uncommon type of stroke that accounts for about
About the STRIVE-ON Trial
The STRIVE-ON trial (NCT05995405) was a prospective, randomized open-label trial of GTx-104 compared with nimodipine oral capsules (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 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 nimodipine oral capsules.
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 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. GTx-104 has been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States if certain conditions are met at NDA approval, and additional intellectual property protection with 52 granted and pending patents.
For more information, please visit: www.gracetx.com.
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 the future prospects of the Company’s GTx-104 drug candidate; the Company’s belief that the issues identified by the FDA in the CRL can be successfully addressed in the Company’s resubmission of the NDA for GTx-104; the Company’s planned approach to addressing the items cited in the CRL following its Type A meeting with the FDA and receipt of the official meeting minutes; the Company’s dual source manufacturing strategy, including remediation at its current contract manufacturer and technology transfer to a second, U.S.-based contract manufacturer; the timing and outcome of any FDA reinspection of the current contract manufacturer; the Company’s plans to complete the required non-clinical studies; and the Company’s plans to report progress against key milestones; GTx-104’s potential to bring enhanced treatment options to patients suffering from aSAH; the ability of GTx-104 to potentially eliminate the need for nasogastric tube administration in unconscious or dysphagic patients; the potential of GTx-104 to lower food effects, drug-to-drug interactions, and to eliminate potential dosing errors; the potential of GTx-104 to better manage hypotension in aSAH patients; and the Company’s intellectual property estate for GTx-104, 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 timing and success of any regulatory resubmission of the NDA for GTx-104; (ii) the timing of any FDA reinspection of the Company’s current contract manufacturer, and that facility’s compliance status, which are determined by the FDA and outside the Company’s control, and the FDA’s position that it will not approve the NDA while the facility remains in an unacceptable compliance status; (iii) the ability of a second, U.S.-based contract manufacturer to generate the required stability and analytical data and to complete a product-specific pre-approval inspection; (iv) the need to complete additional non-clinical studies; (v) the requirement that any resubmission comprehensively address all items cited in the CRL and the risk of review delay; (vi) the Company’s potential need for additional capital, which may not be available on acceptable terms; (vii) changes to regulatory pathways; (viii) the Company’s ability to protect its intellectual property for GTx-104; and (ix) 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, 2026 and its Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, 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 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 |
