Short answer
Definium Therapeutics, Inc. (DFTX) filed an 8-K current report with the SEC on June 22, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.2). Boilerplate Regulation FD exhibit disclaimer, not substantive investor disclosure.
Definium Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Boilerplate Regulation FD exhibit disclaimer, not substantive investor disclosure
- Information is furnished, not filed, limiting its use in liability and SEC filing incorporation contexts
Item 8.01 · Other Events
- Exhibits 99.1 and 99.2 reference June 22, 2026 press release and Emerge topline data presentation
- Emerge topline data likely contains the material clinical update; investor assessment requires reviewing Exhibit 99.2
- CEO Robert Barrow signed the filing on June 22, 2026
Item EX-99.1 · Exhibit EX-99.2
- Phase 3 Emerge met primary and all key secondary endpoints, materially advancing DT120 ODT toward potential FDA submission
- Week 6 MADRS placebo-adjusted improvement of 8.1 points, p<0.0001, supporting statistically significant efficacy
- Rapid effect at Week 1 with 14.2-point placebo-adjusted improvement and durable 7.3-point benefit at Week 12
- Week 6 response rate 35% versus 7% placebo and remission rate 24% versus 3% placebo
- Safety profile generally favorable, with 99% of adverse events mild to moderate and no suicidality signal reported
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
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