Compass Pathways is about to file COMP360 with the FDA by the end of the year. Its patent portfolio is narrower than most people assume: it owns one specific crystal shape of psilocybin, patented down to an X-ray tolerance of ±0.10 degrees. That narrowness is exactly what competitors like Helus Pharma, CaaMTech, Filament Health, and Terran Biosciences are building around.
Registrational psychedelic trials are built entirely around DSM diagnoses, even though the drugs appear to work on neurofunctional domains that cut across them. Tanya Ramey, former Usona CMO and NIDA program director, makes the case for domain-based trial design, and traces why the regulatory system isn't built to reward it yet.
A country-by-country look at where it's currently legal to treat PTSD and depression with MDMA or psilocybin as a medical condition. Switzerland leads on patient volume, Australia and New Zealand on legal durability, the US remains years out.
With Definium's Phase 3 LSD readout this week, it is now possible for the first time to map all major psychedelic drug classes on a credible FDA approval timeline: from esketamine, already approved, to psilocybin and LSD approaching NDA submission, to MDMA navigating a difficult path back, to 5-MeO-DMT watching from a distance.
The Otsuka/Transcend deal is the largest single bet placed on the neuroplastogen thesis. We use it as a lens to examine what standard biotech risk models miss when applied to this space, and introduce the four dimensions that actually matter.
Compass, Usona, and Resilient Pharmaceuticals have made radically different bets on how much psychotherapy a psychedelic drug needs to work. Those bets reflect different theories of mechanism, different IP strategies, and — after the COMP005 Phase 3 readout and the Lykos CRL — very different regulatory outcomes.
Three compounds entered the Warning Flags model. One came out ahead by 37 points.
First scored analysis from the Warning Flags Head-to-Head NCE Edition, comparing Delix's zalsupindole and Gilgamesh's blixeprodil for MDD across seven risk categories.
We scored Transcend's TSND-201 methylone program through our risk estimator. Yellow flag. Here's what the model sees and what it means for investors.
The market priced in the policy tailwind. It priced in the voucher. Now it needs the next concrete event, and that event is Compass completing its NDA. Until then, the sector is in wait state.
On April 18, President Trump signed an executive order directing the FDA to fast-track psychedelic therapies. The market reacted broadly. The real question is which publicly traded companies can actually pull the trigger on expedited review, and when.
The FDA’s REMS framework is the biggest commercial bottleneck in psychedelic drug development, and companies are now engineering around it. Five concrete strategies already unfolding across the pipeline, from non-hallucinogenic neuroplastogens to digital safety layers.
We introduce five scientific pillars to systematically evaluate psychedelics and neuroplastogens, from receptor pharmacology to clinical outcomes. These pillars offer a framework to compare these modalities without bias, clarifying how each translates biological effects into therapeutic potential.
MM120, CYB-003, and GM2505 are redefining what psychedelic drug development looks like in practice. Three compounds, three approaches to tighter control over timing, dose, and clinical delivery.