Grace Therapeutics (NASDAQ: GRCE) gets FDA review date for GTx-104 NDA

Rhea-AI Filing Summary

Grace Therapeutics reported that the U.S. Food and Drug Administration has accepted its New Drug Application for GTx-104 for formal review. GTx-104 is a novel, injectable formulation of nimodipine being developed for intravenous infusion to treat aneurysmal subarachnoid hemorrhage, a condition with significant unmet medical need.

The FDA has set a Prescription Drug User Fee Act, or PDUFA, target decision date of April 23, 2026 for the NDA. This step means the application passed the initial filing review and will now undergo a full regulatory assessment, but it does not represent an approval or guarantee of approval.

Positive

• FDA accepted the NDA for GTx-104, moving the drug candidate into formal regulatory review for aneurysmal subarachnoid hemorrhage.
• PDUFA target date set for April 23, 2026, providing a clear timeline for a potential U.S. approval decision on GTx-104.

Negative

• None.

Insights

Biotech regulatory and valuation analyst

FDA acceptance of Grace’s GTx-104 NDA starts formal review with an April 23, 2026 PDUFA date.

The FDA’s acceptance of the New Drug Application for GTx-104, an injectable nimodipine for aneurysmal subarachnoid hemorrhage, is a key regulatory milestone. Acceptance indicates the submission was complete enough for full review and moves the program from late-stage development into the approval review phase.

The agency set a PDUFA target date of April 23, 2026, giving a clear timeline for a potential approval decision. While this event does not assure a positive outcome, it defines the next major catalyst for the program. Future outcomes will depend on the FDA’s assessment of safety, efficacy, and manufacturing data contained in the NDA.

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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): August 27, 2025

GRACE THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware	001-35776	98-1359336
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

103 Carnegie Center Suite 300 Princeton, New Jersey		08540
(Address of Principal Executive Offices)		(Zip Code)

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:

☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	GRCE	The Nasdaq Stock Market LLC

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 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

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.

On August 27, 2025, Grace Therapeutics, Inc. (the “Company”) issued a press release announcing that, on August 22, 2025, the U.S. Food and Drug Administration (“FDA”) accepted the Company’s New Drug Application (“NDA”) for GTx-104 for formal review. GTx-104 is a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage patients. The FDA established a Prescription Drug User Fee Act (PDUFA) target date of April 23, 2026 for its review of the Company’s NDA submission.

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.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

Exhibit		Description
99.1		Press Release, dated August 27, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

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.

			GRACE THERAPEUTICS, INC.
Date:	August 27, 2025	By:	/s/ Prashant Kohli
			Prashant Kohli Chief Executive Officer

FAQ

What did Grace Therapeutics (GRCE) announce in this filing?

Grace Therapeutics announced that the U.S. Food and Drug Administration accepted its New Drug Application for GTx-104 for formal review and assigned a PDUFA target date of April 23, 2026.

What is GTx-104 in Grace Therapeutics' pipeline?

GTx-104 is described as a clinical-stage, novel, injectable formulation of nimodipine being developed for intravenous infusion to address significant unmet medical needs in patients with aneurysmal subarachnoid hemorrhage.

What is the PDUFA date for Grace Therapeutics' GTx-104 NDA?

The FDA set a Prescription Drug User Fee Act (PDUFA) target date of April 23, 2026 for its review of Grace Therapeutics' New Drug Application for GTx-104.

Does FDA acceptance of the NDA mean GTx-104 is approved?

No. FDA acceptance of the NDA for GTx-104 means the application passed the initial filing review and will undergo full evaluation, but it is not yet approved and there is no guarantee it will be approved.

Which medical condition is Grace Therapeutics targeting with GTx-104?

Grace Therapeutics is developing GTx-104 for patients with aneurysmal subarachnoid hemorrhage, where the company notes there are significant unmet medical needs.

How did Grace Therapeutics communicate the NDA acceptance news?

Grace Therapeutics issued a press release dated August 27, 2025, which is attached as Exhibit 99.1 to this report.