Press release
KemPharm Reports Third Quarter 2022 Results
Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today, November 9, 2022, at 5:00 p.m. ET Significant activities underway for
About this update from Zevra Therapeutics, Inc.
[{"type":"text","content":"Conference Call and Live Audio Webcast with Slide Presentation Scheduled for Today, November 9, 2022, at 5:00 p.m. ET Significant activities underway for preparation of the arimoclomol NDA resubmissionAdvancing key activities to initiate a Phase 2 clinical trial of KP1077 in IH by year-end 2022Total cash (cash, cash equivalents and long-term investments) of $107.4M as of Sep 30, 2022; based on current operating forecast, cash runway extends into 2026 CELEBRATION, Fla., Nov. 09, 2022 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NasdaqGS: KMPH) (KemPharm, or the Company), a biotechnology company focused on the discovery, development and commercialization of novel treatments for rare central nervous system (CNS) and neurodegenerative diseases, lysosomal storage disorders and related treatment areas, today reported its financial results for the quarter ended September 30, 2022. “During Q3, we made substantial progress with our two lead programs, arimoclomol, our NDA-stage product candidate for Niemann-Pick Type C (NPC), an ultra-rare lysosomal disease, and KP1077, our product candidate based on our prodrug of d-methylphenidate, serdexmethylphenidate (SDX), which is intended for the treatment of two rare sleep disorders, idiopathic hypersomnia (IH) and narcolepsy,” stated Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “For arimoclomol, our team has made considerable progress characterizing the substantial data repository and generating a host of summary reports designed to present meaningful evidence of safety and efficacy as part of the NDA resubmission. Based on the recent completion of the 4-year open-label safety trial, the ongoing and constructive dialogue with the FDA and the new wealth of data generated since the CRL, we now anticipate resubmitting the updated NDA as early as Q3 2023. And, while no new or unanticipated issues related to resubmission have arisen, we believe the added time will be well-spent in preparation of an NDA filing with the highest likelihood of approval.” Dr. Mickle continued, “For KP1077, the initial results we reported in October 2022 from the Phase 1 cardiovascular safety trial of SDX demonstrated the potential for ‘higher dose’ SDX to be safe and well-tolerated. We believe this could position KP1077 as an advancement in the treatment of IH, and we remain on track to initiate the Pha...