Traws Pharma (NASDAQ: TRAW) files IND and shares updated COVID-19 study data

Rhea-AI Filing Summary

Traws Pharma, Inc. filed a Form 8-K to highlight a new regulatory and clinical update in its COVID-19 pipeline. The company issued a press release announcing that it has filed a U.S. Investigational New Drug Application with the Food and Drug Administration for tivoxavir marboxil, a potential treatment candidate. The same press release also provides updated results from an ongoing study of ratutrelvir, described as a ritonavir-free treatment being evaluated in both PAXLOVID®-eligible and ineligible patients with mild-to-moderate COVID-19. The press release is attached as an exhibit to the filing, and the company includes standard cautionary language about forward-looking statements and the risks and uncertainties around future results.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): January 13, 2026

Traws Pharma, Inc.

(Exact name of Registrant as specified in its charter)

Delaware		001-36020		22-3627252
(State or Other Jurisdiction of Incorporation or Organization)		(Commission File Number)		(I.R.S. Employer Identification No.)

12 Penns Trail

Newtown, PA 18940

(267) 759-3680

(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive
Offices)

Not Applicable 

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K 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 $.01 per share	TRAW	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 January 13, 2026, Traws Pharma, Inc. (the “Company”) issued a press release (the “Press Release”) announcing the filing of a U.S. Investigational New Drug Application with the U.S. Food and Drug Administration for tivoxavir marboxil and providing updated results from its ongoing study of ratutrelvir, a ritonavir-free treatment, in PAXLOVID®-eligible and ineligible patients with mild-to-moderate COVID-19. A copy of the Press Release is filed as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated by reference into this Item 8.01.

Forward-Looking Statements

This Current Report, including Exhibit 99.1, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms “anticipates,” “expects,” “estimates,” “believes,” “will” and similar expressions, as they relate to the Company or its management, are intended to identify such forward-looking statements.

Forward-looking statements in this Current Report, including Exhibit 99.1, or hereafter, including in other publicly available documents filed with the Securities and Exchange Commission, reports to the stockholders of the Company and other publicly available statements issued or released by the Company involve known and unknown risks, uncertainties and other factors which could cause the Company’s actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management’s best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Securities and Exchange Commission, each of which could adversely affect the Company’s business and the accuracy of the forward-looking statements contained herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press Release, dated January 13, 2026.
104		Cover Page Interactive Data File (embedded within the inline XBRL Document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: January 13, 2026	TRAWS PHARMA, INC.
	By:	/s/ Iain Dukes
		Iain Dukes
		Chief Executive Officer

FAQ

What did Traws Pharma (TRAW) disclose in this Form 8-K?

Traws Pharma, Inc. reported that it issued a press release announcing the filing of a U.S. Investigational New Drug Application for tivoxavir marboxil and providing updated results from its ongoing study of ratutrelvir in patients with mild-to-moderate COVID-19.

What regulatory step did Traws Pharma (TRAW) take for tivoxavir marboxil?

The company filed a U.S. Investigational New Drug Application with the Food and Drug Administration for tivoxavir marboxil, as announced in the attached press release.

What is ratutrelvir and which patients is Traws Pharma studying?

Ratutrelvir is described as a ritonavir-free treatment being studied in PAXLOVID®-eligible and ineligible patients with mild-to-moderate COVID-19, with updated study results discussed in the company’s press release.

How did Traws Pharma (TRAW) communicate these updates to investors?

The company issued a press release dated January 13, 2026, which is filed as Exhibit 99.1 to the Form 8-K and incorporated by reference into the Other Events section.

Does the Traws Pharma 8-K include forward-looking statements?

Yes. The company states that the document, including the press release, contains forward-looking statements identified by terms such as “anticipates,” “expects,” “estimates,” “believes,” and “will,” and notes that these involve risks and uncertainties.

Where can investors find more details about Traws Pharma’s COVID-19 programs?

Additional details are contained in the press release attached as Exhibit 99.1 to the Form 8-K and in other documents the company files with the Securities and Exchange Commission.