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Biotech Stock Crashes 73% on Disappointing Drug Trial Data
28 Jul
Summary
- Twice-daily drug dose met schizophrenia study goals; once-daily dose did not.
- MapLight stock fell 73%, erasing over $1 billion in market value.
- Drug showed cognitive benefits separate from psychotic symptom reduction.
MapLight Therapeutics saw its stock value plummet by 73% on Monday following mixed outcomes from a mid-stage schizophrenia trial for its experimental drug, ML-007C-MA. The study, involving approximately 307 adults, evaluated the drug in once-daily and twice-daily doses over five weeks.
The twice-daily administration successfully met the study's primary objective, demonstrating a statistically significant reduction in schizophrenia symptom severity as measured by the PANSS scale. Furthermore, this regimen showed notable improvements in cognitive functions, which appeared distinct from its effects on psychotic symptoms.
In contrast, the once-daily version of the drug achieved statistical significance on only a few secondary measures, falling short of the main efficacy endpoint. Both dosages were reported as generally well-tolerated with manageable dropout rates and no major safety concerns like movement or metabolic issues.
MapLight intends to engage with the U.S. Food and Drug Administration to plan a confirmatory late-stage trial focusing on the effective twice-daily dose. The company also views these results as supportive for an ongoing trial of the same twice-daily dose in Alzheimer's disease-related psychosis.
