u/United-Collar-944

Author argues the bear case for REGAL/GPS is weaker than it sounds at the CR2-specific level because BAT and V+A are not proven to fully explain the event slowdown. The bull mechanism is a WT1-targeted maintenance immunotherapy that may show delayed separation and long-tail survival in minimal disease, a setting the author says is optimal for a vaccine-like therapy. The catalyst is the unblinded REGAL Phase 3 readout, where the hazard ratio must clear the predefined bar. Main stated risks are Phase 2-to-Phase 3 effect-size regression, open-label variability, and the unforgiving HR threshold.

Author argues Biomea Fusion’s JPM CEO presentation materially de-risked BMEA by framing icovamenib as disease-modifying in insulin-deficient T2D and GLP-1-refractory patients rather than transient early data. The company’s tight, purpose-built Phase 2b and regulatory-anchored language reduce perceived execution and FDA risk, with execution expected in 2025–2026. The author expects the market to gradually re-rate the probability of success over days to weeks and remains constructive/long.