FDA flags CMC, non-clinical issues in Grace (NASDAQ: GRCE) GTx-104 NDA
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Grace Therapeutics, Inc. reported that the U.S. Food and Drug Administration issued a Complete Response Letter for its New Drug Application for GTx-104, an IV nimodipine formulation for aneurysmal subarachnoid hemorrhage. The letter cites outstanding Chemistry, Manufacturing, and Controls and non-clinical items, but does not request additional clinical data.
The cited items involve leachables data for product packaging, non-clinical toxicology risk assessments, and manufacturing deficiencies at the company’s contract manufacturer. Grace plans to request a Type A meeting with the FDA to clarify the path forward and intends to resubmit the application after resolving these issues.
Positive
- None.
Negative
- None.
Insights
FDA issues CRL on GTx-104 NDA over CMC and non-clinical issues.
Grace Therapeutics received a Complete Response Letter for its GTx-104 NDA targeting aneurysmal subarachnoid hemorrhage. The FDA raised concerns in the Chemistry, Manufacturing, and Controls and non-clinical sections, including leachables data, toxicology assessments, and deficiencies at the contract manufacturing organization.
The FDA did not request new clinical data, so existing trial results, including the STRIVE-ON study, remain the clinical foundation. This points to mainly technical and manufacturing remediation rather than efficacy concerns in the excerpt.
Grace intends to request a Type A meeting with the FDA to clarify the required actions and then resubmit its NDA. Actual timing and outcomes will depend on resolving the cited CMC and non-clinical items and any feedback from that meeting and subsequent regulatory interactions.
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
STRIVE-ON GTx-104 patients: 50 patients
STRIVE-ON oral nimodipine patients: 52 patients
Reduction in hypotension incidence: 19% reduction
+5 more
8 metrics
STRIVE-ON GTx-104 patients
50 patients
Patients administered GTx-104 in STRIVE-ON trial
STRIVE-ON oral nimodipine patients
52 patients
Patients receiving oral nimodipine in STRIVE-ON trial
Reduction in hypotension incidence
19% reduction
Clinically significant hypotension with GTx-104 vs oral nimodipine
Hypotension incidence GTx-104 vs oral
28% vs 35%
Patients with at least one clinically significant hypotension episode
High RDI patients GTx-104 vs oral
54% vs 8%
Patients with relative dose intensity ≥95%
Deaths in STRIVE-ON trial
8 vs 4 deaths
Deaths on GTx-104 arm vs oral nimodipine arm
U.S. aSAH patient volume
42,500 patients
Estimated U.S. hospital-treated aneurysmal subarachnoid hemorrhage patients
Stroke share from aSAH
5% of strokes
aSAH share of all strokes
Key Terms
Complete Response Letter, Chemistry, Manufacturing, and Controls, Type A meeting, relative dose intensity, +2 more
6 terms
Complete Response Letter regulatory
"announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)"
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.
Chemistry, Manufacturing, and Controls regulatory
"the FDA referenced certain items in the Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections"
Chemistry, manufacturing, and controls (CMC) is the detailed documentation of how a drug or medical product is made, tested, and kept consistent — like a recipe, factory checklist, and quality-control plan combined. Investors care because strong CMC means regulators are more likely to approve the product and the company can reliably scale production, while weak or incomplete CMC raises the risk of approval delays, production problems, extra costs, or recalls.
Type A meeting regulatory
"The Company intends to request a Type A meeting with the FDA to clarify the path forward"
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.
relative dose intensity financial
"54% patients on GTx-104 had relative dose intensity (RDI) of 95% or higher compared to only 8%"
orphan drug designation regulatory
"lead clinical assets have each been granted Orphan Drug Designation by the Food and Drug Administration (FDA)"
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.
aneurysmal subarachnoid hemorrhage medical
"being developed for intravenous infusion 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.
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): April 23, 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 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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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
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Other Events
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On April 23, 2026, Grace Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has issued a
Complete Response Letter for the Company’s New Drug Application for GTx-104 in the treatment of patients with aneurysmal subarachnoid hemorrhage.
A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.
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Financial Statements and Exhibits.
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Description
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99.1
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Press Release, dated April 23, 2026.
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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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April 23, 2026 |
By:
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/s/ Prashant Kohli
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Prashant Kohli
Chief Executive Officer
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Exhibit 99.1
Grace Therapeutics Provides Regulatory Update on New Drug Application for GTx-104
FDA Issued Complete Response Letter Citing Outstanding Items Related to Chemistry, Manufacturing, and Controls and
Non-Clinical Information
FDA Does not Request Additional Clinical Data
Company Intends to Resubmit Application Following Resolution of Cited Items
Princeton, NJ, April 23, 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 the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Company’s New Drug Application (NDA) for GTx-104 for the treatment of patients with aSAH.
In its CRL, the FDA referenced certain items
in the Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections of the application, which Grace believes it can address in a resubmission of its NDA. The cited items are related to leachables data for product packaging,
non-clinical product toxicology risk assessments, and product manufacturing deficiencies at our contract manufacturing organization. The Company intends to request a Type A meeting with the FDA to clarify the path forward and determine the
appropriate next steps.
“Potential FDA approval of our NDA for GTx-104 for the treatment of aSAH would represent the first meaningful innovation in the standard
of care for these patients in more than 40 years,” said Prashant Kohli, Chief Executive Officer of Grace Therapeutics. “We are confident in the robust data package supporting our NDA submission, and that the CMC issues identified by the FDA can be
successfully addressed in our resubmission.”
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 in the U.S.
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.
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 Company’s belief that it
can address the items related to CMC and non-clinical information cited in the FDA’s Complete Response Letter in a resubmission of its NDA for GTx-104; the Company’s intentions to request a Type A meeting with the FDA to clarify the path forward
and determine the appropriate next steps for GTx-104; 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 any regulatory resubmission related to the Phase 3 STRIVE-ON safety trial for GTx-104; (ii) changes to
regulatory requirements or pathways; (iii) our ability to protect our intellectual property for our drug candidates; and (iv) 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
What did the FDA communicate to Grace Therapeutics (GRCE) about GTx-104?
The FDA issued a Complete Response Letter for Grace Therapeutics’ GTx-104 New Drug Application for aneurysmal subarachnoid hemorrhage, citing outstanding Chemistry, Manufacturing, and Controls and non-clinical items that must be addressed before the application can be approved.
Did the FDA request additional clinical trials for GTx-104 in this GRCE update?
The FDA did not request additional clinical data for GTx-104. The issues in the Complete Response Letter focus on Chemistry, Manufacturing, and Controls and non-clinical information, including packaging leachables, toxicology risk assessments, and manufacturing deficiencies at the contract manufacturing organization.
How did GTx-104 perform versus oral nimodipine in the STRIVE-ON trial?
In the STRIVE-ON trial, GTx-104 showed a 19% reduction in patients with at least one clinically significant hypotension episode versus oral nimodipine (28% versus 35%), with additional measures such as relative dose intensity and functional outcomes generally favoring GTx-104 or being comparable.
What are Grace Therapeutics’ next regulatory steps for GTx-104 after the CRL?
Grace Therapeutics plans to request a Type A meeting with the FDA to clarify the required actions and appropriate next steps, and intends to resubmit the GTx-104 New Drug Application after addressing the Chemistry, Manufacturing, and Controls and non-clinical issues cited.
What safety outcomes were observed with GTx-104 in aneurysmal subarachnoid hemorrhage patients?
Adverse events were comparable between GTx-104 and oral nimodipine, and no new safety issues were identified. There were eight deaths on the GTx-104 arm and four on the oral nimodipine arm, with one oral nimodipine patient’s survival status unknown; deaths were attributed to underlying disease severity.
What unmet medical need is GTx-104 designed to address for GRCE?
GTx-104 is an IV formulation of nimodipine for aneurysmal subarachnoid hemorrhage, aiming to simplify delivery in intensive care, potentially reduce dosing errors, food effects, and drug interactions, and improve management of hypotension compared with oral nimodipine in this life-threatening condition.