Psychedelic drug development is entering a catalyst-heavy era as new late-stage anxiety data from Definium Therapeutics is expected this week and Compass Pathways confirms the timing of key steps in moving its psychedelic candidate closer to a possible market launch, according to an Aug. 10 announcement.
The industry is awaiting Definium’s Phase 3 Voyage readout for the single-dose oral LSD candidate DT120 in generalized anxiety disorder, expected within days. Earlier this summer, Definium shared late-stage Emerge data showing an 8.1-point placebo-adjusted change from baseline over six weeks on a scale of major depressive disorder symptoms. Stifel analysts wrote that these results “exceeded expectations with clear and highly robust efficacy in the MDD population.”
Jefferies analysts said they are “70-75%+ confident a single-dose can safely produce a rapid, robust and durable” benefit out to week 12, citing late-stage MDD data and findings from a Phase 2b GAD study. The analysts also stated, “In our view, single-dose DT120 has produced the most profound Phase 2/3 datasets for both indications.” Stifel analysts said that MDD data help derisk GAD studies due to significant overlap between populations, and will be looking for strong statistical significance in this week’s expected readout.
A second dataset from another Phase 3 study called Panorama is expected in September. Jefferies predicts at least $1.5 billion peak sales in MDD and GAD for DT120, with total valuation surpassing $9 billion if upcoming results reconfirm efficacy. The LSD candidate is also being developed for post-traumatic stress disorder, with a late-stage trial planned for 2027.
Compass Pathways recently announced that its depression candidate COMP360 is under active FDA review with part of its new drug application now filed. H.C. Wainwright said, “COMPASS has shifted from data generation to filing and launch execution, with initial modules from the rolling new drug application for COMP360 in treatment resistant depression under FDA review.” Two pivotal trials earlier this summer demonstrated durability of efficacy for Compass’ synthetic psilocybin asset in treatment resistant depression; the program received a Commissioner’s National Priority Voucher intended to speed up review processes aligned with U.S. national priorities.
