What We're Watching: Compass's Filing Clock, Definium's First Call Since Its Rally, and the Ibogaine Deadline
The next two weeks will decide a lot. Here's what's on our calendar, and one study from this week.
Nov 9: Definium reports Q3 (4:30pm ET). Shares have roughly doubled in the past month, and this is the company's first call since. The trial data is already out. Two Phase 3 trials of DT120 for generalized anxiety came back positive, as did a depression trial. What's missing is a filing date. We'll be listening for when Definium plans to submit its NDA and in which indication it goes first. The second depression trial, Ascend, doesn't read out until 2027.
Nov 11: Compass at the Stifel healthcare conference. CEO Kabir Nath gets a second chance to answer the question he declined on the Nov 3 call: what a two-company psilocybin market looks like now that Usona has filed. Compass's cash, which it says lasts into 2028, means it can wait for approval without raising money first.
Around Nov 17: Compass's two-week filing window closes. On Nov 3, Nath said the rolling NDA for COMP360 would be complete "in the next two weeks." Once it's in, the company's National Priority Voucher could shrink the FDA's review to one to two months. That would put both psilocybin applications, Compass for treatment-resistant depression and Usona for major depression, in front of the FDA at the same time. Both programs are on our trials tracker.
Nov 20: FDA's ibogaine comment deadline. This is the last day to respond to the FDA's request for input on how early ibogaine trials should be designed. The agency named opioid use disorder and PTSD as priority populations and flagged heart-rhythm and neurotoxicity risks. It has said it won't consider comments on legalization or scheduling. Texas, now under Gov.-elect Gina Hinojosa, and Arizona run state-funded ibogaine trials, and both will be watching what comes back.
Further out: who writes the FDA's next funding bill. With Democrats taking the Senate, Bernie Sanders is expected to lead the Senate health committee, RAPS reports. That's the committee Bill Cassidy chaired. It shapes the reauthorization of FDA user fees, the industry money that pays for drug reviews. The law expires Sept. 30, 2027, and the FDA's recommendations are due to Congress by Jan. 15. In past reauthorization cycles, Sanders was often the lone vote against it in committee. Our midterms breakdown covers the rest of the new map.
On our desk: a new study from the University of Melbourne and the Florey Institute, covered by Eric W. Dolan at PsyPost. Researchers James Gattuso, Anthony Hannan and Thibault Renoir gave mice bred to model schizophrenia one dose of psilocybin. In females, it restored sensory filtering for about nine days. The study is small, uses one genetic strain, and the effect appeared in only one sex. It's exactly the kind of single-lab, lasting-effect result that this week's five-lab replication suggests we should hold loosely. The lead author warns against self-treatment. People with schizophrenia or a family history of psychosis are typically excluded from psychedelic trials for safety reasons.
Nothing here is medical advice.