secwatch.observer — SEC 8-K summary
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Issuer:     Definium Therapeutics, Inc. (DFTX)
CIK:        0001813814
Form:       8-K
Filed at:   2026-09-08T12:00:15+00:00
Accession:  0001193125-26-384403
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Definium gets second FDA Breakthrough Therapy designation for DT120 in MDD
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- FDA granted Breakthrough Therapy designation for DT120 ODT in major depressive disorder; second BTD for program after GAD.
- Phase 3 Emerge: single 100 µg dose showed 8.1-point placebo-adjusted MADRS improvement at Week 6 (p<0.0001), durable to Week 12.
- MDD affects >21M US adults annually; fewer than one-third of patients reach remission with current treatments.
- CEO Rob Barrow says designation underscores DT120's potential to transform treatment for serious mental health disorders.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1813814/000119312526384403/0001193125-26-384403-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1813814/000119312526384403/dftx-20260908.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-384403

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