Market reactionShares fell 11% on Nov 2.
Definium develops DT120 ODT, a single-dose tablet form of lysergide (LSD) for anxiety and depression; it is not approved anywhere.
DT120 ODT is a single dose of lysergide given as a dissolving tablet. It met primary and key secondary endpoints in three Phase 3 trials: Voyage and Panorama in generalized anxiety disorder and Emerge in depression. FDA granted Breakthrough Therapy designation in both conditions. Definium plans a pre-NDA meeting in the fourth quarter of 2026 and a GAD filing in the first half of 2027. About $1.1 billion of cash funds operations into 2030.
Thesis checklist
0 risks need attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: GAD NDA is filed and accepted
Does Definium submit the GAD NDA on time, with FDA agreement on the data package?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
DT120 ODT won three Phase 3 trials; the GAD filing is due early 2027
Two Phase 3 wins and dual BTDs in hand — Panorama and Ascend will test whether DT120 ODT's efficacy generalizes across GAD and MDD at scale
DT120 ODT's Phase 3 MDD win sets up GAD readouts as the next binary — two pivotal trials will confirm or break the multi-indication thesis
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Disease areas: Psychiatric disorders
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
11 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.