dexmethylphenidate prodrug ER (KP484) / Commave Therap, Zevra Therap - LARVOL DELTA

[VIRTUAL] Oral, Intranasal, and Intravenous Abuse Potential of Serdexmethylphenidate, a Novel Prodrug of d-Methylphenidate (APSARD 2021) - "SDX is currently under development as the major active pharmaceutical ingredient (API) in late-stage (KP415) and early-stage (KP484) investigational products for the treatment of ADHD. Abuse-related subjective measures, plasma samples, and safety data were collected. Studies were conducted in accordance with FDA Guidance on abuse potential (2017)."

ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

KemPharm reports third quarter 2019 results (KemPharm Press Release) - "For Q3 2019, KemPharm reported revenue of $11.5 million, which included the $10 million upfront payment, development cost reimbursements and consultation fee revenue generated under the KP415/KP484 License Agreement...General and administrative expenses for Q3 2019 were $3.6 million, which was an increase of $0.6 million compared to Q3 2018, primarily driven by an increase in professional fees incurred in connection with the KP415 licensing process and partially offset by a decrease in personnel costs."

Commercial

KemPharm announces entry into definitive collaboration and license agreement for its ADHD candidates, KP415 and KP484, with an affiliate of Gurnet Point Capital (GlobeNewswire) - "KemPharm...today announced its entry into a definitive collaboration and license agreement (the License Agreement) with an affiliate of Gurnet Point Capital (GPC)...The License Agreement provides for an exclusive worldwide license to develop, manufacture and commercialize KemPharm’s product candidates containing serdexmethylphenidate (SDX) and d-methylphenidate (d-MPH), including KemPharm’s attention deficit and hyperactivity disorder (ADHD) product candidates, KP415 and KP484....Up to a Total of $493 Million in Upfront, Sales and Development Milestone Payments, as well as Royalties on Net Sales..."

Licensing / partnership

KemPharm reports second quarter 2019 results (GlobeNewswire) - "...During the quarter, we took a number of steps to reduce our operating, general and administrative expenses, including an approximate 30% reduction in workforce compared to the end of Q1 2019, with the goal of reducing our cash burn rate while maintaining our research and development capabilities to support our ongoing work with KP415 and KP484, as well as remaining positioned to support the ultimate commercial partner once that process has been completed....Looking ahead, once this partnership is finalized, we will focus our full attention in conjunction with our partner to finalize the NDA for KP415, which we believe could likely be filed prior to year-end."

Commercial • NDA