MapLight's ML-004 Phase 2 IRIS Trial Misses Primary Endpoint, Shows Strong Irritability Signal in Adolescents
MPLT has more than doubled off its 52-week low of $12.24 on elevated volume (4.6× avg).
Summary
MapLight's ML-004 Phase 2 IRIS trial missed its primary endpoint for social communication deficits in autism spectrum disorder. However, the drug demonstrated a statistically significant and clinically meaningful improvement in irritability within a prespecified adolescent subgroup, and was well-tolerated. This news follows an 8-K filed earlier today that briefly disclosed the trial results. While the primary endpoint miss is a setback, the positive irritability signal offers a potential new development path for ML-004. The company plans to engage the FDA in an End-of-Phase 2 meeting to determine next steps for development in irritability associated with ASD.
At the time of this announcement, MPLT was trading at $25.92 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.2B. The 52-week trading range was $12.24 to $33.28. This news item was assessed with neutral market sentiment and an importance score of 8 out of 10. Source: Wiseek News.