Home/Filings/8-K/0001104659-26-003071
8-K//Current report

Traws Pharma, Inc. 8-K

Accession 0001104659-26-003071

$TRAWCIK 0001130598operating

Filed

Jan 12, 7:00 PM ET

Accepted

Jan 13, 7:00 AM ET

Size

231.3 KB

Accession

0001104659-26-003071

Research Summary

AI-generated summary of this filing

Updated

Traws Pharma Files IND for Tivoxavir; Updates Ratutrelvir Study

What Happened
On January 13, 2026, Traws Pharma, Inc. announced in a press release (filed on Form 8‑K) that it has submitted a U.S. Investigational New Drug (IND) application to the FDA for tivoxavir marboxil. The company also provided updated results from its ongoing study of ratutrelvir, a ritonavir‑free oral treatment being studied in both PAXLOVID®‑eligible and PAXLOVID‑ineligible patients with mild‑to‑moderate COVID‑19. The press release is included as Exhibit 99.1 to the Form 8‑K.

Key Details

  • Date of announcement: January 13, 2026.
  • Regulatory action: Submission of a U.S. IND application to the FDA for tivoxavir marboxil.
  • Clinical update: Updated results reported for ratutrelvir, a ritonavir‑free oral antiviral studied in PAXLOVID‑eligible and PAXLOVID‑ineligible patients with mild‑to‑moderate COVID‑19.
  • Filing: Press release incorporated into the Form 8‑K as Exhibit 99.1.

Why It Matters
An IND submission is a formal step toward beginning clinical trials in the U.S. for tivoxavir marboxil, signaling progression of Traws Pharma’s pipeline and regulatory engagement with the FDA. Updated data on ratutrelvir — a ritonavir‑free option — is relevant because it targets patients who may be ineligible for ritonavir‑containing therapies like PAXLOVID due to drug interactions. For investors, these developments are material to the company’s clinical progress and potential future milestones, though the filing does not include financial results or management changes.