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AI brief of an SEC Form 8-K · Definium Therapeutics, Inc. (DFTX)

Definium Therapeutics Receives FDA Breakthrough Therapy Designation for DT120 in MDD

Positive Impact 3 of 5 other Written later

Definium Therapeutics said the U.S. Food and Drug Administration granted Breakthrough Therapy designation to DT120 ODT for major depressive disorder. This is the program's second Breakthrough Therapy designation, following one for generalized anxiety disorder. The filing reports no financial figures, and the designation is based on Phase 3 Emerge study results.

Key points

  • FDA granted Breakthrough Therapy designation for DT120 ODT in major depressive disorder, announced September 8, 2026
  • Second Breakthrough Therapy designation for the DT120 program, after the designation for generalized anxiety disorder
  • Phase 3 Emerge study: single 100 µg dose showed an 8.1-point placebo-adjusted MADRS improvement at Week 6 (p<0.0001)

The filing

CompanyDefinium Therapeutics, Inc. (DFTX)
Form8-K, current report
Filed with the SECSep 8, 2026, 8:00 AM ET
Accession number0001193125-26-384403

Items reported: 8.01 Other Events

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 11:43 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 08, 2026.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.