Grace Therapeutics is rated a Speculative Buy with a $4 price target, implying 57% upside after a sharp drop from a CMC-only FDA CRL. The FDA's concerns for GTx-104 are limited to fixable chemistry, manufacturing, and controls issues, with no efficacy or safety objections raised. A scenario-weighted DCF model assigns a 75% probability of approval, forecasting $100M peak risk-adjusted U.S. sales and highlighting a favorable risk/reward profile.
On Monday, Grace Therapeutics, Inc. GRCE, formerly b, announced topline data from its Phase 3 STRIVE-ON safety trial of GTx-104 compared with oral nimodipine in patients hospitalized with aneurysmal Subarachnoid Hemorrhage (aSAH).