VLON - Vallon crashes after lead program for ADHD candidate did not meet main goal

Clinical-stage biopharmaceutical company, Vallon Pharmaceuticals (NASDAQ:VLON) has lost ~77% in the pre-market Monday after announcing that its lead program for ADAIR did not meet primary endpoint in attention deficit hyperactivity disorder (ADHD). The pivotal SEAL study was designed to evaluate the ADAIR, an abuse-deterrent formulation of immediate release (IR) dextroamphetamine in 55 subjects. Based on topline data from 52 patients who completed the trial, ADAIR did not meet the primary endpoint of a significant reduction in Emax Drug Liking for compared to reference dextroamphetamine, the company said. However, there was a trend in favor of the candidate (p=0.16), and the study’s all pharmacodynamic secondary endpoints were achieved with statistical significance. Following additional analysis of data, the company expects to decide on the next steps for the program which could include a meeting with regulators and plans for another trial. “As we gain additional insight from further analysis of all study endpoints,

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Vallon crashes after lead program for ADHD candidate did not meet main goal