Lykos Therapeutics — The FDA published the previously confidential complete response letter it issued to Lykos Therapeutics in 2024 for MDMA-assisted therapy in PTSD, part of a release of 89 unpublished CRLs under a new transparency policy.
The letter detailed concerns including high rates of prior MDMA use among trial participants and screening issues, and it reiterated the agency's request for an additional Phase 3 study. The disclosure sharpened public understanding of the regulatory bar facing MDMA and the broader psychedelic field.
Source: psychedelicalpha.com
For the rest of that week's sector news, read our week in review.