Traws Pharma (TRAW) plans Q3 2026 MHRA resubmission for Phase 2a flu study
Rhea-AI Filing Summary
Traws Pharma, Inc. is preparing an updated toxicology data package for tivoxavir marboxil to address information requests from the UK Medicines and Healthcare Products Regulatory Agency (MHRA). The company expects to resubmit this package in the third quarter of 2026 to allow a planned Phase 2a human influenza challenge study in healthy volunteers to proceed.
Management believes the study could provide important proof-of-concept data for tivoxavir marboxil as an oral prophylaxis for seasonal influenza. Traws notes that tivoxavir marboxil has shown broad in vitro activity across multiple seasonal influenza strains and a pharmacokinetic profile consistent with chemoprophylactic use, and it plans to profile additional molecules in its influenza treatment program.
Positive
- None.
Negative
- None.
8-K Event Classification
Key Figures
Key Terms
Medicines and Healthcare Products Regulatory Agency regulatory
Phase 2a human influenza Challenge study medical
chemoprophylactic agent medical
IND filing regulatory
clinical hold regulatory
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
(Exact name of Registrant as specified in its charter)
| (State or Other Jurisdiction of Incorporation or Organization) |
(Commission File Number) |
(I.R.S. Employer Identification No.) |
| ( |
(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 |
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 7.01 Regulation FD Disclosure.
On June 22, 2026, Traws Pharma, Inc. (the “Company”) issued a press release (the “Press Release”) announcing that it intends to resubmit an updated data package to the United Kingdom’s Medicines and Healthcare Products Regulatory Agency for the planned testing of tivoxavir marboxil. A copy of the Press Release is attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Current Report”) and is incorporated by reference into this Item 7.01.
The information included in this Current Report under this Item 7.01 (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
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 reasonable 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 June 22, 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: June 22, 2026 | TRAWS PHARMA, INC. | |
| By: | /s/ Charles Parker | |
| Charles Parker | ||
| Chief Financial Officer | ||
Exhibit 99.1
Traws Pharma Provides Updated Guidance on Influenza Prophylaxis Program
Resubmission of updated data package to MHRA, expected in 3Q 2026, to enable Phase 2a human influenza Challenge study to proceed
NEWTOWN, PA — June 22, 2026 — (GLOBENEWSWIRE) Traws Pharma, Inc. (NASDAQ: TRAW, Traws, the Company), a clinical-stage biopharmaceutical company developing novel therapies for critical global viral threats, today announced that an updated toxicology data package is in the process of being developed in response to information requirements from the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the planned testing of tivoxavir marboxil (TXM) in a Phase 2a human influenza Challenge study. The updated data package is expected to be resubmitted to MHRA during the third quarter of 2026. “Based upon recent feedback and further guidance from the MHRA, we believe our updated data package will support the proposed seasonal influenza Challenge study to be conducted in healthy volunteers and provide important proof of concept data for TXM’s use as an oral prophylaxis medicine,” commented Iain D. Dukes, MA, DPhil, Chief Executive Officer for Traws Pharma.
Following Traws’ announcement on June 12,.2026, the MHRA provided more detailed feedback that has enabled the Company to prepare additional preclinical safety information for inclusion in the TXM data package. Following the resubmission, the Company expects a formal response from MHRA within 30 days.
“TXM demonstrated broad in vitro efficacy across multiple strains of seasonal influenza and a pharmacokinetic profile consistent with its use as a chemoprophylactic agent,” said C. David Pauza, PhD, Chief Science Officer for Traws Pharma. “The Company will also initiate profiling of additional molecules for advancement in its program for influenza treatment.”
“Seasonal influenza continues to be a major public health threat in the US and worldwide,” commented Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma. “Influenza treatment and prevention is especially important for vulnerable populations including elderly and immunocompromised individuals who are at much greater risk for severe influenza compared to the general population.”
About Traws Pharma, Inc.
Traws Pharma is a clinical-stage biopharmaceutical company dedicated to developing novel therapies to target critical threats to human health in respiratory viral diseases. Traws integrates antiviral drug development, medical intelligence and regulatory strategy to meet real world challenges in the treatment of viral diseases. The Company is advancing novel investigational oral small molecule antiviral agents that have potent activity against difficult to treat or resistant virus strains that threaten human health including seasonal influenza and H5N1 bird flu, negative-strand RNA viruses including Hantavirus, Ebola Virus Disease, Lassa Fever and COVID-19/Long COVID.
For more information, please visit www.trawspharma.com and follow us on LinkedIn.
Forward-Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, market size, benefits, effectiveness, safety, and the clinical and regulatory plans for tivoxavir marboxil and ratutrelvir and other investigational antiviral agents, as well as plans for its legacy programs. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the outcome of the MHRA resubmission for tivoxavir marboxil, the outcome of Traws’ IND filing with the FDA for tivoxavir marboxil, including the current FDA clinical hold; the success and timing of Traws’ clinical trials; Traws’ ability to identify and advance potential clinical candidates for the treatment of Hantavirus infections, Ebola Virus Disease, Lassa Fever, the potential efficacy of ratutrelvir for the treatment of COVID-19, including the potential to reduce the risk of COVID rebound and Long COVID; the potential for tivoxavir marboxil and ratutrelvir and other investigational antiviral agents to gain market acceptance, if and when regulatory approval is obtained, or to become the new standard of care; Traws’ interactions with the FDA, MHRA, BARDA, CDC, NAFDAC, AMA and similar foreign regulators; collaborations; market conditions; regulatory requirements and pathways for approval; the ongoing need for improved therapy to reduce the frequency of clinical rebound and the concomitant risk for Long COVID; the extent of the spread and threat of pandemic flu including H5N1 bird flu; the Company’s cash projections; Traws’ ability to raise additional capital when needed; and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events, except to the extent required by law.
Traws Pharma Contact:
Charles Parker
Traws Pharma, Inc.
cparker@trawspharma.com
www.trawspharma.com
Investor Contact:
John Fraunces
LifeSci Advisors, LLC
917-355-2395
jfraunces@lifesciadvisors.com