KMPH - KemPharm stock rises ~8% amid start of dosing in phase 1 trial of SDX

KemPharm (NASDAQ:KMPH) said the first person was dosed in a phase 1 trial evaluating relative cardiovascular safety of serdexmethylphenidate (SDX) compared to immediate-release and long-acting formulations of Ritalin (racemic methylphenidate), a commonly prescribed central nervous system (CNS) stimulant. The company said SDX, its proprietary prodrug of d-methylphenidate (d-MPH), is the sole active pharmaceutical ingredient in KP1077, which KemPharm is developing as a treatment for idiopathic hypersomnia (IH), a rare sleep disorder. "The intent of this clinical trial is to collect additional data to support the ongoing development of our SDX-based product candidates, in particular, KP1077, and further differentiate SDX from other methylphenidate-based products," said KemPharm's President and CEO Travis Mickle. The phase 1 open-label trial will enroll up to 15 volunteers. The company said it expects to file an investigational new drug application for KP1077 with the U.S. Food and Drug Administration as early as this quarter. If the application is accepted, the company plans

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KemPharm stock rises ~8% amid start of dosing in phase 1 trial of SDX