serdexmethylphenidate intranasal (KP415 intranasal) / 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 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

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

KemPharm presenting four scientific posters at APSARD's 2019 Annual Meeting (GlobeNewswire) - "KemPharm...today announced that research assessing the oral and intranasal human abuse potential (HAP) of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), as well as new pharmacokinetic (PK) data for KP415, will be presented in four posters and one oral 'data blitz session' at the 2019 Annual Meeting of the American Professional Society for ADHD and Related Disorders (APSARD) being held in Washington, D.C., starting today, January 18th, through January 20th."

P1 data • PK/PD data