MapLight’s Schizophrenia Candidate Posts Mixed Phase II Results as Shares Plummet

Overview

• MapLight reported that the twice-daily 210/3 mg regimen of ML-007C-MA met the Phase II primary endpoint and several secondary measures in adults with acute exacerbation of schizophrenia.
• The once-daily 330/6 mg arm failed to show a statistically significant improvement versus placebo at five weeks, removing a clear convenience advantage that investors had hoped would differentiate the drug.
• The randomized study enrolled 307 patients over five weeks and found the twice-daily group had about a 4.5-point greater reduction on the PANSS total score and measurable cognitive benefit versus placebo.
• Investors reacted sharply to the mixed readout and the dosing uncertainty, driving reported declines in MapLight shares of roughly 40% to 55% and raising near-term commercial concerns.
• MapLight said the data support an additional registrational trial, will discuss next steps with the FDA, and continues a parallel Alzheimer’s psychosis program with top-line results expected in H2 2027 while ML-007C-MA would face competition from BMS’s Cobenfy if approved.