What are the projected regulatory milestones and potential timeline for FDA approval of MM120 following this trial?

Regulatory outlook: The JAMA‑published Phase 2b data give MindMed a credible springboard to seek an FDA Fast‑Track or Breakthrough‑Therapy designation for MM120, both of which are typically pursued after a pivotal proof‑of‑concept read‑out. Assuming the Company files an IND amendment and requests a Type B meeting within the next 2‑3 months, the FDA could grant Fast‑Track status by late 2024. That would set the stage for a pivotal Phase 3 trial that MindMed is likely to launch in Q2‑2025, targeting a 12‑ to 18‑month enrollment period (given the 198‑patient Phase 2b experience). If enrollment proceeds on schedule, topline Phase 3 results would be expected by mid‑2026, allowing an NDA submission in the second half of 2026. Under standard review the FDA’s decision window is 10 months; with a priority review (which Fast‑Track can enable) it would shrink to 6 months. Consequently, the earliest realistic FDA approval date for MM120 is early‑to‑mid 2027, with a more probable window of late 2027‑early 2028.

Trading implications: The publication of robust Phase 2b results has already lifted sentiment (≈+70) and injected near‑term upside potential into MNMD. However, the stock remains highly dependent on the timing and outcome of the upcoming Phase 3 program and any regulatory designation. Traders should watch for the Company’s filing of a Fast‑Track/Breakthrough request (expected by Q4 2024) and the subsequent Phase 3 initiation announcement. A successful Fast‑Track grant would likely trigger a short‑term rally and justify a “buy‑on‑dip” approach for investors with a 12‑18 month horizon. Conversely, any delays in Phase 3 enrollment or a missed FDA meeting could pressure the share price. Position sizing to the risk of a binary outcome (Phase 3 success vs. failure) and maintaining a stop‑loss near the recent low (≈$2.00) would be prudent while the upside to a potential 2027 approval remains priced in.