MapLight's schizophrenia drug fails once-daily test, shares plunge

The drug was generally well tolerated, with no serious or treatment-related severe side effects reported, MapLight said.

Schizophrenia and related psychotic disorders affect an estimated 0.25% to 0.64% of the U.S. population, and people with the condition lose an average of 28.5 years of life, according to the National Institutes of Health.

The company said the data support an additional registrational trial and that it plans to discuss the next steps with the U.S. Food and Drug Administration. MapLight is also studying the drug in Alzheimer's disease psychosis, with top-line results expected in the second half of 2027.

Patients receiving the once-daily 330/6 mg dose did not show a statistically significant improvement in symptoms compared with placebo after five weeks, missing the trial's main goal.

The twice-daily 210/3 mg dose, however, met the trial's main goal at five weeks versus placebo, along with several key secondary goals, including improvements in disease severity and positive schizophrenia symptoms.

Investors and analysts had been closely watching how the drug would measure up against Bristol Myers Squibb's Cobenfy, a recently approved schizophrenia treatment dosed twice daily. Leerink Partners analysts said in a note last week that some investors viewed the once-daily regimen as a key way for the drug to differentiate itself from Cobenfy and other treatments in the market.

July 27 (Reuters) - MapLight Therapeutics said on Monday its schizophrenia drug failed to show statistically significant symptom improvement in the once-daily dosing arm of a mid-stage trial, sending its shares tumbling 55% in premarket trading.

The company was testing ML-007C-MA, a combination of betovumeline and fesoterodine, in adult patients with schizophrenia experiencing an acute exacerbation of psychosis.