secwatch.observer — SEC 8-K summary
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Issuer:     Definium Therapeutics, Inc. (DFTX)
CIK:        0001813814
Form:       8-K
Filed at:   2026-05-12T12:15:16+00:00
Accession:  0001193125-26-218251
Event type: other_material
Sentiment:  neutral
Materiality: 0.40
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Definium doses first patient in Phase 3 Ascend study of DT120 ODT for MDD; topline data expected 2027
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- First patient dosed in Ascend, second Phase 3 pivotal study of DT120 ODT (lysergide tartrate) for major depressive disorder.
- Primary endpoint: change from baseline in MADRS score at Week 6 for DT120 ODT 100 µg vs placebo.
- Study to enroll 175 participants in the U.S.; topline data from 12-week double-blind period anticipated in 2027.
- Ascend design aligns with Emerge Phase 3 and GAD trials; includes 40-week open-label extension and 2:1:2 randomization.
- 50 µg DT120 arm included to confound dose condition awareness and address functional unblinding concerns.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1813814/000119312526218251/0001193125-26-218251-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1813814/000119312526218251/dftx-20260512.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-218251

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer