Grace Therapeutics Advances Critical Care Pipeline with Key FDA Filing

Rhea-AI Filing Summary

Grace Therapeutics (NASDAQ:GRCE) filed an 8-K announcing the submission of a New Drug Application (NDA) to the FDA for GTx-104, a novel injectable formulation of nimodipine. The drug candidate is being developed as an IV infusion treatment for patients with aneurysmal subarachnoid hemorrhage. This represents a significant regulatory milestone in the company's drug development pipeline.

Positive

• Submission of New Drug Application to FDA for GTx-104
• Addressing unmet medical needs in aneurysmal subarachnoid hemorrhage treatment
• Development of novel injectable formulation for critical care application

Negative

• Regulatory approval timeline uncertain
• No guarantee of FDA acceptance or final approval

Insights

Pharmaceutical Industry Analyst

NDA submission for GTx-104 marks crucial advancement in addressing critical unmet needs in hemorrhage treatment.

The submission of the NDA for GTx-104 represents a significant milestone in Grace Therapeutics' development pipeline. The focus on an injectable formulation of nimodipine demonstrates strategic positioning in the critical care space, particularly for subarachnoid hemorrhage treatment. The IV delivery method could potentially offer advantages over existing treatment options, addressing important unmet medical needs in this serious condition. This regulatory filing could position Grace Therapeutics to capture market share in the neurovascular therapeutics segment if approved.

false0001444192NASDAQ00014441922025-06-252025-06-25

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): June 25, 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 June 25, 2025, Grace Therapeutics, Inc. issued a press release announcing its submission of a New Drug Application to the U.S. Food and Drug Administration for GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage patients. 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 June 25, 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:	June 25, 2025	By:	/s/ Prashant Kohli
			Prashant Kohli Chief Executive Officer

FAQ

What is Grace Therapeutics' GTx-104 drug candidate?

GTx-104 is a novel, injectable formulation of nimodipine being developed for IV infusion to treat patients with aneurysmal subarachnoid hemorrhage.

What regulatory milestone did Grace Therapeutics achieve?

Grace Therapeutics submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for GTx-104 on June 25, 2025.

What medical condition does GTx-104 target?

GTx-104 targets aneurysmal subarachnoid hemorrhage, addressing significant unmet medical needs in this patient population.

Who is leading Grace Therapeutics?

The company is led by Prashant Kohli, who serves as Chief Executive Officer.