Grace Therapeutics (Nasdaq: GRCE) outlines GTx-104 trial gains and FDA plan
Rhea-AI Filing Summary
Grace Therapeutics, Inc. reports receipt of official U.S. FDA Type A meeting minutes regarding the Complete Response Letter for its GTx-104 new drug application. The minutes confirm that the CRL raised only chemistry, manufacturing and controls issues, including contract-manufacturer cGMP compliance and additional leachables and excipient toxicology data, and did not cite clinical safety or efficacy deficiencies or request new clinical trials.
The company plans to resubmit the NDA after addressing all items through a dual-source manufacturing strategy and required non-clinical studies, with remediation at its existing contract manufacturer and parallel technology transfer to a second U.S. site. Supporting this plan, Phase 3 STRIVE-ON data in hospitalized aneurysmal subarachnoid hemorrhage patients showed a 19% relative reduction in clinically significant hypotension with GTx-104 versus oral nimodipine (28% vs 35%), higher dose intensity (54% vs 8% achieving ≥95% of planned dose), fewer ICU and ventilator days, and fewer ICU readmissions, with comparable overall safety. GTx-104 holds FDA Orphan Drug Designation, Grace cites an estimated 42,500 U.S. hospital-treated aSAH patients annually, and it reported $17.0 million of cash and 16,024,026 common shares outstanding as of March 31, 2026.
Positive
- None.
Negative
- None.
Filing Explained
Outstanding, immediately exercisable warrants could add 4,418,292 shares; dilution is potential rather than completed.
The filing adds a capitalization disclosure: outstanding warrants are immediately exercisable, while the stated exercise proceeds remain potential rather than received, leaving any related share issuance and dilution conditional.
A warrant converts to shares when exercised; issuing those additional shares would reduce existing holders’ percentage ownership absent offsetting changes.
The presentation identifies warrants exercisable for 4,418,292 shares, with an aggregate exercise price of approximately
As of
Sources and calculations
- Grace Therapeutics Form 8-K and attached exhibits (2026-07-28)
- Dilution definition (2026-07-17)
- Grace Therapeutics latest quarterly fundamentals (2026-03-31)
- Cash and equivalents vs quarterly operating cash outflow, in days of cash use $16,977,000 / ($1,695,000 / 90) = [object Object]
8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Reduction in clinically significant hypotension: 19%
Patients achieving ≥95% relative dose intensity: 54% vs 8%
ICU length of stay reduction: 1.5 days
+5 more
8 metrics
Reduction in clinically significant hypotension
19%
Relative reduction with GTx-104 vs oral nimodipine in STRIVE-ON (28% vs 35% of patients)
Patients achieving ≥95% relative dose intensity
54% vs 8%
GTx-104 vs oral nimodipine in STRIVE-ON Phase 3 trial
ICU length of stay reduction
1.5 days
Mean ICU stay 16.4 days on GTx-104 vs 17.9 days on oral nimodipine
Ventilator days reduction
5 days
Mean mechanical ventilation 5.6 days on GTx-104 vs 10.6 days on oral nimodipine
ICU readmission reduction
48%
Relatively fewer ICU readmissions with GTx-104 vs oral nimodipine
Annual U.S. hospital-treated aSAH patients
42,500
Estimated number of aneurysmal subarachnoid hemorrhage patients treated in U.S. hospitals
Cash and cash equivalents
$17.0 M
Balance as of March 31, 2026
Potential warrant exercise proceeds
$15.0 M
Gross proceeds from February 2025 private placement warrants if fully exercised
Key Terms
Complete Response Letter, Type A Meeting, current good manufacturing practice (cGMP), Orphan Drug Designation, +2 more
6 terms
Complete Response Letter regulatory
"to discuss the Complete Response Letter issued on April 23, 2026 for the Company’s GTx-104 NDA"
A complete response letter is an official communication from a drug or medical-device regulator, such as the U.S. Food and Drug Administration (FDA), telling a company that a marketing application cannot be approved in its current form and listing the specific deficiencies to be fixed. For investors it matters because it pauses or delays a product’s path to market—like a building inspector issuing a list of repairs before a certificate of occupancy—affecting revenue timing, costs and stock value.
Type A Meeting regulatory
"receipt of the U.S. Food and Drug Administration (FDA) meeting minutes from a Type A Meeting held with the FDA"
A Type A meeting is an urgent, short-notice session requested between a company and a regulatory agency (for example, the FDA in the U.S.) to resolve critical issues that block a development program, such as a clinical hold or safety concern. Investors care because the outcome can immediately affect whether a clinical trial or approval process resumes, changing timelines, costs and the company’s near-term value — like calling an emergency mechanic when a car won’t start so a trip can continue.
current good manufacturing practice (cGMP) regulatory
"items cited by the FDA relate to the current good manufacturing practice (cGMP) compliance status of the Company's contract manufacturer"
Current good manufacturing practice (cGMP) are regulatory rules that require drug, medical device, and certain food makers to follow up-to-date standards for production, quality control, cleanliness, documentation, and staff training so products are consistently safe and effective. For investors, cGMP compliance is like a company passing routine safety inspections: it lowers the risk of costly recalls, regulatory fines, and production shutdowns, and supports steady revenue and preserved company value.
Orphan Drug Designation regulatory
"GTx-104 has been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
relative dose intensity medical
"54% patients on GTx-104 had relative dose intensity of 95% or higher compared to only 8% on oral nimodipine"
pharmacoeconomic outcomes financial
"secondary endpoints included safety, clinical, and pharmacoeconomic outcomes"
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What did the FDA communicate to Grace Therapeutics (GRCE) about the GTx-104 NDA?
The FDA’s Type A meeting minutes confirm the GTx-104 Complete Response Letter focused on manufacturing, not clinical, issues. The agency did not identify any clinical safety or efficacy deficiencies and did not request additional clinical data or new trials.
What issues in GRCE’s GTx-104 Complete Response Letter must be resolved before NDA resubmission?
The CRL items concern the cGMP compliance status of Grace’s contract manufacturer and certain non-clinical data. These include additional leachables time points and excipient toxicology risk assessments, all of which the company plans to address in its NDA resubmission package.
How did GTx-104 perform versus oral nimodipine in GRCE’s STRIVE-ON Phase 3 trial?
GTx-104 showed a 19% relative reduction in clinically significant hypotension compared with oral nimodipine, 28% versus 35% of patients. It also achieved 54% versus 8% of patients at ≥95% dose intensity, with fewer ICU and ventilator days and comparable safety.
What manufacturing strategy is Grace Therapeutics (GRCE) pursuing for GTx-104?
Grace is advancing a dual-source manufacturing strategy for GTx-104. Its current contract manufacturer is remediating cGMP findings for FDA reinspection, while a second U.S.-based contract manufacturer is undergoing technology transfer to provide an additional compliant registration site.
What is the market opportunity and regulatory status for GTx-104 at Grace Therapeutics (GRCE)?
GTx-104 targets aneurysmal subarachnoid hemorrhage, with about 42,500 U.S. hospital-treated patients annually. It has FDA Orphan Drug Designation, which can provide seven years of U.S. marketing exclusivity if required conditions are met at NDA approval.
What is Grace Therapeutics’ (GRCE) capital position and warrant potential?
Grace reported $17.0 million in cash and equivalents and 16,024,026 common shares outstanding as of March 31, 2026. Outstanding February 2025 private placement warrants could generate up to $15.0 million in gross proceeds upon exercise.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 28, 2026
(Exact Name of Registrant as Specified in its Charter)
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Registrant’s telephone number, including area code: (609 ) 322-1602
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule
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Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to
Section 13(a) of the Exchange Act. ☐
| Item 8.01. |
Other Events.
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On July 28, 2026, Grace Therapeutics, Inc. (the “Company”) issued a
press release announcing 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 issued on April 23, 2026 for the Company’s GTx-104 new drug
application. In addition, the Company updated its corporate presentation on July 28, 2026 to reflect the path to NDA resubmission following
the Type A Meeting.
A copy of the press release and updated corporate presentation are attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K and are
incorporated by reference into this Item 8.01.
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Financial Statements and Exhibits.
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(d) Exhibits
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Exhibit
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Description
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99.1
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Press Release, dated July 28, 2026.
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99.2
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Corporate Presentation – Late Summer 2026.
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document).
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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GRACE THERAPEUTICS, INC.
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Date:
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July 28, 2026
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By:
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/s/ Prashant Kohli
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Prashant Kohli
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Chief Executive Officer
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Exhibit 99.1
Grace Therapeutics Announces Receipt of Type A Meeting Minutes
from U.S. Food and Drug Administration
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, NJ, 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 5% of all strokes and an estimated 42,500 U.S. hospital treated patients.
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 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 the GTx-104 arm and the oral nimodipine arm, including: 54% patients on GTx-104 had relative dose intensity 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 in the GTx-104 arm compared to four deaths in the oral nimodipine
arm. The survival status of one patient in the oral nimodipine arm was unknown. No deaths were determined to be related to GTx-104 or oral nimodipine.
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
Exhibit 99.2
