Short answer
Definium Therapeutics, Inc. (DFTX) filed an 8-K current report with the SEC on August 12, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.2). Positive topline Phase 3 Voyage data for DT120 ODT in generalized anxiety disorder.
Definium Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Positive topline Phase 3 Voyage data for DT120 ODT in generalized anxiety disorder
- Potential regulatory and commercialization catalyst for Definium’s lead program
- Full efficacy, safety, and statistical results contained in Exhibit 99.1
Item 8.01 · Other Events
- August 12, 2026 press release and Voyage topline data presentation filed as exhibits
- Voyage data may materially influence DFTX’s clinical-development outlook and investor expectations
- Investors should review Exhibit 99.1 and Exhibit 99.2 for efficacy, safety, and program decisions
Item EX-99.1 · Exhibit EX-99.2
- Phase 3 Voyage met primary and all key secondary endpoints in 214 GAD patients, materially advancing DT120 ODT toward potential approval
- HAM-A improvement at Week 12: -11.6 DT120 versus -6.2 placebo, placebo-adjusted difference 5.4 points, p<0.0001, Cohen’s d=0.81
- Efficacy emerged by Day 2 and persisted through Week 12, supporting DT120’s potential for rapid and durable symptom relief
- Week 12 response rate 43% versus 16% placebo; remission rate 14% versus 4%
- Generally well tolerated with no new safety signals; 92% met end-of-session criteria by hour 8, while Panorama results are expected in September
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