One of the two leading companies will announce new data showing how well their psilocybin therapy works, or announce a formal meeting with the FDA to discuss approval. Compass already reported results; MAPS is earlier. Either company sharing next-step news matters because it moves closer to actual FDA approval.
Compass Pathways has already reported primary Phase 3 COMP360 results (published late 2025). A follow-up analysis, secondary endpoint publication, or FDA Type C/pre-NDA meeting announcement within six months is plausible but not certain—Compass's path forward depends on whether they pursue an NDA given mixed Phase 3 results. MAPS PBC's psilocybin program is earlier stage. Resolves YES if either company issues a press release or SEC filing referencing Phase 3 efficacy data or a scheduled FDA pre-approval meeting. Original confidence preserved; reasoning sharpened.