In a most remarkably accelerated process, the Psychedelics, which constitute a novel and heterogeneous class of therapeutic candidates, are soon to take their revolutionary leap from investigational to commercial, as Compass’ COMP360/psilocybin appears likely to receive FDA approval during 4Q, setting the stage for a nearterm first launch of a classical psychedelic, this for Treatment Resistant Depression. The stunning success of JNJ’s Spravato has demonstrated the market viability for innovative options for in-clinic interventional Psychiatry, and we expect several psychedelic compounds to reach the Market and be successful. This class is not a panacea, but represent a very useful, at times dramatically successful, alternatives for difficult-to-treat disorders. In addition to TRD,MDD, PTSD, GAD, and Addiction are areas that will benefit from these options. ibogaine (the least understood and most risk-laden psychedelic) has received particular and surprising attention in the Addiction space. Big Pharma has not yet embraced this class, but AbbVie and Otsuka have made significant investments in promising psychedelic assets. Over $1.2 billion has been raised by psychedelics companies thus far in 2026, led by the most advanced clinical-stage companies: Compass, Definium, AtaiBeckley, Gilgamesh, and Helus. The subgroup that seen its ascendancy at least temporarily slowed is the non-hallucinogenic psychoplastogen category, which has found funding hard to come by.
This review assesses over fifty companies, including Compass, Definium, Atai Beckley, AbbVie, Otsuka/Transcend, Gilgamesh, Helus, Enveric, GH Research, Resilient, Reunion, Equulus, CaamTech, Delix, and Psilera.
The Huntington’s area is going through a revolution of its own, as the mechanistic model increasingly shifts emphasis from mutant huntingtin to the somatic expansion process that leads to the generation of extended CAG repeats. LoQus23, Latus Bio, and Pfizer are among the companies pursuing MSH3 targeting. But huntingtin is still a major focus, Roche’s decision to go into another tominersen PhIII with early-stage patients struck us as an attempt to traverse an unbridgeable gap between efficacy and safety–the outcome will be known shortly. We are more optimistic about the Skyhawk PhII/III trial expected to finish a year from now, curious about Alnylam’s PhIb, and resigned to a long wait for Novartis/PTC’s PhIII, though we will see if they seek Accelerated Approval based on the trial already completed. uniQure’s regulatory journey has become a saga of its own, with an unfortunately politicized FDA reversing itself and giving uniQure the go-ahead for filing based on a tiny PhII cohort in comparison to a historical control group. If they are willing to do so for Huntington’s, the list of rare but not ultra-rare neurodegenerative disorders that could justify similar treatment includes ALS, FTD, and Spinocerebellar Ataxia, to name but three. Dispensing with placebo-controlled testing for these other disorders is a slippery slope the Agency did not fully consider.
The third area is Migraine, the first time in eight years we have reviewed this area, one which went through its own revolution as the CGRP targeting programs achieved dominance. The triptans and CGRP drugs still leave a significant portion of the Migraine population undertreated, we suspect that PACAP targeting will be the next major advance, with Lundbeck in front, Slate, Mentari, and Vedana trailing. In the meantime, Axsome will target CGRP nonresponders with its recently approved Symbravo.
The Summer issue also comments on clinical datasets from Praxis, Alto, Neumora, Definium, and acquisitions by Lilly (Centessa) and UCB (Neurona). Denmark’s Lophora is the subject of this issue’s Company Spotlight.
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