Definium Nears Phase 3 Anxiety Data as Compass Moves COMP360 Through FDA Review
Updated
Updated · BioSpace · Aug 10
Definium Nears Phase 3 Anxiety Data as Compass Moves COMP360 Through FDA Review
2 articles · Updated · BioSpace · Aug 10
Summary
Definium Therapeutics is due to report Phase 3 Voyage data on DT120 in generalized anxiety disorder within days, a readout analysts say could lift the stock 25% to 50% or more.
Jefferies said it is 70%-75% confident the single-dose oral LSD candidate will show rapid, durable benefit through week 12, citing strong Phase 2b GAD results and Definium’s earlier 8.1-point placebo-adjusted Phase 3 depression data.
A second Phase 3 GAD dataset from the Panorama study is expected in September, with investors focused not just on efficacy and p-values but on how large the commercial opportunity is in a market with no new GAD launches for 20 years.
Compass Pathways said its COMP360 depression program is already under active FDA review through a partially filed rolling NDA, keeping it on track for a fourth-quarter submission and a potential first-half 2027 launch.
The twin milestones underscore a catalyst-heavy period for psychedelic drug developers, with Jefferies projecting at least $1.5 billion in peak DT120 sales and Compass aiming to become the first company to market a psychedelic therapy.