$DFTX·8-K

Definium Therapeutics, Inc. · May 12, 8:15 AM ET

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Definium Therapeutics, Inc. 8-K

Research Summary

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Definium Therapeutics Announces First Patient Dosed in Phase 3 DT120 Study

What Happened
Definium Therapeutics, Inc. (DFTX) filed an 8-K on May 12, 2026 (Item 8.01) announcing that the first patient has been dosed in its Phase 3 Ascend study of DT120 Orally Disintegrating Tablet (ODT) for Major Depressive Disorder (MDD). The company issued a press release about the milestone (filed as Exhibit 99.1).

Key Details

  • Event date filed: May 12, 2026.
  • Drug candidate: DT120 Orally Disintegrating Tablet (ODT).
  • Trial: Phase 3 "Ascend" study in Major Depressive Disorder — first patient dosed.
  • Filing: Press release attached as Exhibit 99.1 to the Form 8-K; filing signed by CEO Robert Barrow.

Why It Matters
Dosing the first patient in a Phase 3 trial is a major clinical milestone that advances DT120 into the pivotal stage of development. For investors, this creates a near-term clinical development milestone and potential upcoming catalysts (trial enrollment updates, interim or topline results, regulatory interactions). The filing itself is informational — it confirms the company is progressing its lead program and provides a reference (press release) for further details.

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