Definium Therapeutics’ closely watched anxiety readout could further validate its single-dose LSD candidate, while Compass Pathways advances a psilocybin program through a rolling FDA filing.
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.
The industry is excitedly awaiting Definium’s Phase 3 Voyage readout for the single-dose oral LSD candidate DT120 in generalized anxiety disorder (GAD), expected in the next few days. Earlier this summer, Definium shared late-stage Emerge data demonstrating an 8.1-point placebo-adjusted change from baseline over six weeks on a scale of major depressive disorder (MDD) symptoms. Stifel analysts at the time wrote that the results “exceeded expectations with clear and highly robust efficacy in the MDD population.”
Now, the biotech—formerly known as MindMed—plans to share anxiety data this week, findings that could push Definium’s stock up “25-50% or more,” Jefferies analysts wrote in a Thursday note.
“We are 70-75%+ confident a single-dose can safely produce a rapid, robust and durable” benefit out to week 12, Jefferies wrote, citing the late-stage MDD data and “compelling” findings from a Phase 2b GAD study.
“In our view, single-dose DT120 has produced the most profound Phase 2/3 datasets for both indications,” the analysts said.
Stifel analysts agree that the MDD data help derisk the GAD studies, adding in a note last Thursday that there is also “significant overlap between the MDD and GAD populations.” Stifel will be looking for a strong p-value in this week’s expected readout.
A second DT120 dataset from another Phase 3 study called Panorama, also in GAD, is expected in September.
“While these studies are largely expected to work, the broader investor question with this readout is what are the revenue implications, and what does the GAD commercial opportunity look like given (1) most GAD is treated by primary care and (2) there haven’t been any new GAD launches for 20 years to serve an analog,” Stifel wrote.
Jefferies analysts are predicting at least $1.5 billion peak sales in MDD and GAD for DT120, with an expected total valuation surpassing $9 billion.
“We expect the Street to entertain a higher peak sales for GAD (and MDD) if the two upcoming Phase 3 GAD datasets reconfirm profound efficacy—implying even more stock upside,” Jefferies wrote.
The LSD candidate is also being developed for post-traumatic stress disorder, with a late-stage trial slated to launch in 2027.
The current favorable macroenvironment for psychedelics and potential commercial launch of Compass Pathways’ oral psilocybin—which would be the first marketed psychedelic if approved—should also boost interest in Definium, according to the analysts.
Last week, Compass shared that its depression candidate COMP360 is under active FDA review, with a new drug application (NDA) now partially filed. The news confirms the expected timeline of a fourth quarter filing and commercial launch for the first half of next year.
“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 (TRD) under FDA review,” H.C. Wainwright wrote in a Friday note.
Earlier this summer, two pivotal trials demonstrated the durability of efficacy for Compass’ synthetic psilocybin asset in TRD. The program has received a Commissioner’s National Priority Voucher (CNPV), a designation designed to speed up the review process for drugs that align with U.S. national priorities.
Compass also confirmed that the FDA has started asking questions after reviewing submitted modules, which H.C. Wainwright analysts believe is “the most tangible evidence yet that the Commissioner’s National Priority Voucher and rolling framework are functioning as intended.”
