Grace Therapeutics Provides Regulatory Update on New Drug Application for GTx-104

Rhea-AI Summary

Grace Therapeutics (Nasdaq: GRCE) announced the FDA issued a Complete Response Letter (CRL) on April 23, 2026 for the NDA for GTx-104, citing items in Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections.

The FDA did not request additional clinical data. Cited issues include leachables data for packaging, non-clinical toxicology risk assessments, and manufacturing deficiencies at the contract manufacturer. The company intends to request a Type A meeting and resubmit after addressing the items.

Positive

• FDA did not request additional clinical data
• Company intends to resubmit NDA after resolving cited items
• Plans to request a Type A meeting with FDA

Negative

• NDA received a CRL dated April 23, 2026 citing CMC and non-clinical issues
• Cited deficiencies include leachables data gaps and toxicology risk assessments
• Manufacturing deficiencies identified at the contract manufacturing organization

News Market Reaction – GRCE

-45.48% 1.6x vol

11 alerts

-45.48% Session close to close

-60.0% Trough in 6 hr 28 min

$71.80M Market Cap

1.6x Rel. Volume

In the Apr 23 session, GRCE declined 45.48%, reflecting a significant negative market reaction. Argus tracked a trough of -60.0% from its starting point during tracking. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. Trading volume was above average at 1.6x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock dropped -45.5% in the session following this news. A negative reaction despite the absence...

Analysis

The stock dropped -45.5% in the session following this news. A negative reaction despite the absence of new clinical deficiencies fits the material nature of a CRL on GTx-104’s NDA. Historically, most clinical-trial-tagged news produced positive moves, with an average of 3.62%, making a sharp decline a notable deviation. The market may focus on CMC, packaging leachables, and contract manufacturing issues as key risks until the company clarifies timelines and addresses FDA feedback in a planned Type A meeting.

Previous Clinical trial Reports

5 past events · Latest: Apr 14 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Apr 14	Conference abstract	Positive	+12.0%	Phase 3 STRIVE-ON safety trial results accepted for AAN 2026 poster.
Oct 23	NDA review / warrants	Positive	+1.9%	Warrant exercises and funding following FDA acceptance of GTx-104 NDA.
Sep 22	Phase 3 data	Positive	+0.3%	Pivotal STRIVE-ON Phase 3 safety data presented at neurocritical care meeting.
Aug 27	NDA acceptance	Positive	-4.5%	FDA acceptance of GTx-104 NDA with PDUFA date set for April 23, 2026.
Feb 10	Phase 3 results	Positive	+8.3%	Phase 3 STRIVE-ON met primary endpoint with improved safety versus oral nimodipine.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical/NDA milestones for GTx-104 have usually led to modestly positive price moves, with only one notable negative reaction in past clinical-trial-tagged news.

Recent Company History

Over the past year, Grace Therapeutics has advanced GTx-104 through key milestones: positive Phase 3 STRIVE-ON safety data, NDA submission and FDA acceptance with a PDUFA date of April 23, 2026, and multiple scientific presentations. Historical clinical-trial-tagged news often produced positive single-day moves, including +12.04% on an AAN 2026 abstract and +8.33% on pivotal STRIVE-ON results, while NDA acceptance in Aug 2025 saw a −4.51% reaction.

Key Terms

complete response letter, new drug application, chemistry, manufacturing, and controls, non-clinical, +4 more

8 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.

new drug application regulatory

"Complete Response Letter (CRL) for the Company’s New Drug Application (NDA) for GTx-104"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

chemistry, manufacturing, and controls regulatory

"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.

non-clinical regulatory

"Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections of the application"

Non-clinical describes research or activities that do not involve testing in human subjects, such as laboratory experiments, animal studies, manufacturing checks, and safety assessments. For investors, labeling data or work as non-clinical signals earlier-stage evidence—think of it as a prototype tested in a workshop rather than in real-world use—so findings are useful but less predictive of final regulatory approval and commercial success, affecting risk and timelines.

leachables technical

"cited items are related to leachables data for product packaging"

Leachables are chemical substances that migrate from packaging, container materials, or medical devices into a drug, vaccine, or other healthcare product during storage or use. They matter to investors because these contaminants can alter a product’s safety, effectiveness, or shelf life, trigger regulatory action, recalls, or costly reformulation, and therefore affect sales, timelines, and company valuations—think of a flavor from a plastic cup seeping into a drink and changing whether people can safely consume it.

contract manufacturing organization technical

"product manufacturing deficiencies at our contract manufacturing organization"

A contract manufacturing organization (CMO) is a company that makes drugs, medical devices, or other health products on behalf of another firm, handling production, quality checks and often regulatory paperwork. For investors, CMOs matter because they let product owners scale up or cut costs without large factory investments, but they also concentrate operational and regulatory risk—so a dependable CMO can speed revenue and reduce capital needs, while problems at a CMO can disrupt supply and value.

type A meeting regulatory

"The Company intends to request a Type A meeting 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.

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.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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, N.J., 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.

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 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 Grace Therapeutics (GRCE) announce about the NDA for GTx-104 on April 23, 2026?

They announced the FDA issued a Complete Response Letter for the GTx-104 NDA, citing CMC and non-clinical items. According to the company, the FDA did not request additional clinical data and the firm intends to resubmit after addressing cited items.

Does the FDA CRL for GRCE's GTx-104 require new clinical trials?

No — the FDA did not request additional clinical data in the CRL. According to the company, the cited items relate to CMC, leachables, non-clinical toxicology, and manufacturing, which the company believes can be resolved without new clinical studies.

What specific issues did the FDA cite in the GTx-104 CRL for GRCE?

The FDA referenced gaps in leachables data, non-clinical product toxicology risk assessments, and product manufacturing deficiencies at the contract manufacturer. According to the company, these are the items it intends to address before resubmission.

What next steps will Grace Therapeutics take after the CRL for GTx-104?

The company intends to request a Type A meeting with the FDA to clarify the path forward and determine next steps. According to the company, it plans to resolve the cited CMC and non-clinical items and then resubmit the NDA.

Will the CRL for GTx-104 change the clinical development requirements for GRCE?

Based on the announcement, clinical development requirements were not changed because the FDA did not request additional clinical data. According to the company, the CRL focuses on CMC and non-clinical issues that the company aims to address pre-resubmission.