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AI brief of an SEC Form 8-K · Definium Therapeutics, Inc. (DFTX)

Definium reports positive Phase 3 Voyage topline results for DT120 ODT in anxiety

Positive Impact 4 of 5 other Written later

Definium Therapeutics announced positive topline results from Voyage, its first Phase 3 study of DT120 ODT in generalized anxiety disorder, meeting its primary and all key secondary efficacy endpoints. The filing reports a placebo-adjusted HAM-A change of 5.4 points at Week 12 (p<0.0001) and states the drug was generally well tolerated, with no new safety signals identified. The results support the company's development program, but the filing does not describe any regulatory approval, and the second Phase 3 GAD study, Panorama, is expected to report topline results in September 2026.

Key points

  • Primary endpoint: HAM-A change of -11.6 for DT120 ODT versus -6.2 for placebo at Week 12, a difference of -5.4 points (p<0.0001)
  • Study enrolled 214 participants across approximately 35 U.S. sites; 107 received DT120 ODT and 107 received placebo in the reported highlights
  • Company reported no suicidality signal or suicidal behavior; the average time to meet end-of-session criteria was 6.4 hours
  • Panorama, the second Phase 3 GAD study, has a topline readout anticipated in September 2026

The filing

CompanyDefinium Therapeutics, Inc. (DFTX)
Form8-K, current report
Filed with the SECAug 12, 2026, 8:05 AM ET
Accession number0001104659-26-094528

Items reported: 7.01 Regulation FD Disclosure8.01 Other Events

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on August 12, 2026.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.