Next issueIssue 16 · Tue 29 Sep 

Companies

Definium Therapeutics

HQ
United States
Registry
SEC EDGAR · CIK 1813814
Status
active
Listing
Listed · DFTX
Current stage
Three positive Phase 3 readouts (Emerge MDD June 2026, Voyage GAD 2026-08-12, Panorama GAD 2026-09-14); FDA Breakthrough Therapy designation in MDD (announced 2026-09-08) and GAD; pre-NDA meeting guided 4Q 2026, NDA filing guided 1H 2027

sec.govregistryverified 2026-09-15

Notes on the record

Formerly Mind Medicine (MindMed) Inc.; name changed 2026-01-09, 8-K dated 2026-01-12, same SEC registrant. Lead asset appears as MM120 on ClinicalTrials.gov and DT120 in company materials; one molecule, two names. Supersedes the row verified 2026-08-24. Panorama 8-K filed 2026-09-14 (Item 7.01 press release, Item 8.01 presentation); BTD 8-K filed 2026-09-08 (Item 8.01). Five Form 4s filed 2026-09-14, contents not read.

Assets

  • DT120 (registry title MM120)

    Phase 3 across four trials; Emerge (MDD), Voyage (GAD) and Panorama (GAD) read out positive, Ascend (MDD) pending. Panorama topline 2026-09-14 (8-K Item 7.01, EX-99.1): HAM-A LS mean change at Week 12 -9.8 on 100 ug vs -4.7 placebo, placebo-adjusted -5.1 (p<0.0001, d=0.64); n=96 100 ug, n=97 placebo, n=52 50 ug control arm not powered for comparison, placebo-adjusted -3.6 at Week 12; 245 participants, about 32 sites; no drug-related SAEs, no suicidality signal; TEAE rate 94.8% vs 62.9% placebo. Voyage (2026-08-12) placebo-adjusted -5.4, d=0.81. FDA Breakthrough Therapy designation in MDD announced 2026-09-08 (8-K Item 8.01), the second after GAD · major depressive disorder (Emerge, Ascend); generalised anxiety disorder (Voyage, Panorama)

    sec.govregistryverified 2026-09-15

Registered trials

  • NCT06741228ClinicalTrials.gov

    PHASE3 · Generalized Anxiety Disorder · ACTIVE_NOT_RECRUITING · United States

    clinicaltrials.govctgov registryverified 2026-09-15

  • NCT06809595ClinicalTrials.gov

    PHASE3 · Generalized Anxiety Disorder · ACTIVE_NOT_RECRUITING · Czechia, France, Germany, Poland, United Kingdom, United States

    clinicaltrials.govctgov registryverified 2026-09-08

  • NCT06941844ClinicalTrials.gov

    PHASE3 · Major Depressive Disorder · ACTIVE_NOT_RECRUITING · United States

    clinicaltrials.govctgov registryverified 2026-08-31

  • NCT07592689ClinicalTrials.gov

    PHASE3 · Major Depressive Disorder · RECRUITING · United States

    clinicaltrials.govctgov registryverified 2026-08-31

  • 2024-513572-17-00CTIS

    Therapeutic confirmatory (Phase III) · Generalized Anxiety Disorder (GAD) · Authorised · Czechia, France, Germany, Poland

    euclinicaltrials.euctis registryverified 2026-08-31

Deals

This company is not a party to any row in data/deals.csv.

In the briefing

3 issues tagged DEFINIUM.