Allarity Therapeutics (NASDAQ: ALLR) gains FDA Fast Track for stenoparib

Rhea-AI Filing Summary

Allarity Therapeutics, Inc. reported that the U.S. Food and Drug Administration has granted Fast Track designation to stenoparib, its investigational treatment for patients with advanced ovarian cancer. The company disclosed that this development was announced in a press release dated August 26, 2025, which is included as an exhibit to the report.

Positive

• FDA Fast Track designation granted to stenoparib, the company’s investigational treatment for patients with advanced ovarian cancer, marking a significant regulatory milestone for its pipeline.

Negative

• None.

Insights

Biopharma regulatory analyst

FDA Fast Track status for stenoparib is a notable regulatory milestone for Allarity’s ovarian cancer program.

The company states that the U.S. Food and Drug Administration has granted Fast Track designation to stenoparib, its investigational treatment for patients with advanced ovarian cancer. Fast Track designation is typically reserved for therapies targeting serious conditions with unmet medical need, so receiving it can signal that regulators view the indication and therapy focus as important.

This development concentrates the company’s pipeline narrative around advanced ovarian cancer and may increase investor attention on clinical progress and future regulatory interactions related to stenoparib. Future disclosures in company filings may provide additional detail on clinical data, study design, or next regulatory steps following this designation.

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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 26, 2025

ALLARITY THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-41160		87-2147982
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

123 E Tarpon Ave,

Tarpon Springs, FL 34689

(Address of principal executive offices)

(401) 426-4664

(Registrant’s telephone number, including area code)

Not applicable

(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		ALLR		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 26, 2025, Allarity Therapeutics, Inc. (the “Company”) announced in a press release that the U.S. Food and Drug Administration has granted Fast Track designation to stenoparib, the Company’s investigational treatment for patients with advanced ovarian cancer. The Company’s press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number		Description
99.1		Press Release, dated August 26, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

1

SIGNATURE

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.

	Allarity Therapeutics, Inc.
Date: August 27, 2025	By:	/s/ Thomas H. Jensen
		Thomas H. Jensen
		Chief Executive Officer

2

FAQ

What did Allarity Therapeutics (ALLR) disclose in this 8-K filing?

Allarity Therapeutics reported that the U.S. Food and Drug Administration granted Fast Track designation to stenoparib, its investigational treatment for patients with advanced ovarian cancer, as announced in an August 26, 2025 press release.

Which Allarity Therapeutics drug received FDA Fast Track designation?

The filing states that stenoparib, Allarity Therapeutics’ investigational treatment for patients with advanced ovarian cancer, has been granted Fast Track designation by the U.S. Food and Drug Administration.

For which condition is stenoparib being developed by Allarity Therapeutics (ALLR)?

According to the disclosure, stenoparib is an investigational treatment for patients with advanced ovarian cancer.

How did Allarity Therapeutics announce the FDA Fast Track news?

Allarity Therapeutics announced the Fast Track designation for stenoparib in a press release dated August 26, 2025, which is filed as Exhibit 99.1 to this report.

Where can investors find more details about Allarity’s FDA Fast Track designation?

Investors can review Exhibit 99.1, the press release dated August 26, 2025, which is incorporated by reference and may contain additional information about the Fast Track designation for stenoparib.