serdexmethylphenidate IV (KP415 IV) / Zevra Therap, Commave Therap - LARVOL DELTA

KemPharm presents data from intranasal and intravenous human abuse potential trials of KP415 prodrug at the American Academy of Child & Adolescent Psychiatry Meeting (KemPharm Press Release) - P3, N=30; KP415.A03; P1, N=45; KP415.A02; Sponsor: KemPharm; "KemPharm...today announced the presentation of posters from two human abuse potential (HAP) trials for its KP415 prodrug candidate to treat attention deficit hyperactivity disorder (ADHD).  The posters will be presented today at the 65th Annual American Academy of Child and Adolescent Psychiatry (AACAP) Meeting in Seattle, Washington....The posters presented at AACAP with key data from the KP415 HAP program, combined with the feedback from key opinion leaders (KOLs) provided at our recent Investor Event highlight the pre-market commercial perceptions that we believe will be valuable to a potential partner."

P1 data • P3 data • Attention Deficit Hyperactivity Disorder • CNS Disorders

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 Q4 and FY 2018 results (GlobeNewswire) - "Completed KP415 clinical and human abuse potential programs...Due to the recent government shutdown, our pre-NDA meeting with the FDA has been delayed into the second quarter. However, once that meeting is complete, we expect to file the NDA for KP415 shortly thereafter and also in the second quarter...Entering into this facility with Lincoln Park Capital adds flexibility for KemPharm...strengthens our balance sheet as we seek the best possible outcome from the KP415/KP484 partnering process, and we believe it provides the potential to extend our cash runway up to a potential PDUFA date for KP415."

Licensing / partnership • NDA • Trial completion

KemPharm announces enhancements to U.S. and global intellectual property estate (GlobeNewswire) - "KemPharm...today announced continued enhancements to its U.S. and global intellectual property estate governing its portfolio of prodrug product candidates...In addition, KemPharm has augmented and strengthened the global patent estate for KP415 with the addition of issued patents last year in Canada, Japan and Korea."

Patent