Press release
Zevra Therapeutics Reports Corporate Updates and Second Quarter 2023 Financial Results
Completed collaborative and productive pre-submission meeting with FDA for arimoclomol NDA in August 2023; filing expected in Q4 2023 Net revenue of $8.5M for
About this update from Zevra Therapeutics, Inc.
[{"type":"text","content":"Completed collaborative and productive pre-submission meeting with FDA for arimoclomol NDA in August 2023; filing expected in Q4 2023 Net revenue of $8.5M for Q2 2023, which includes $5 million milestone payment earned under the AZSTARYS® license agreement Ended Q2 2023 with $87.4 million in cash, cash equivalents, and investments, supporting our forecasted cash runway into 2026 Conference call and live audio webcast with slide presentation scheduled for today, August 14, 2023, 8:30 a.m. ET CELEBRATION, Fla., Aug. 14, 2023 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the quarter ended June 30, 2023. Recent Business and Corporate Highlights: Continued advancement of the arimoclomol New Drug Application (NDA) for resubmission to the U.S. Food and Drug Administration (FDA): Completed a productive and collaborative pre-submission meeting with the FDA in August 2023, receiving important information that will be used to finalize the NDA for resubmission. NDA package is anticipated to be submitted in Q4 2023. Year-to-date net sales of AZSTARYS® surpassed $25 million, triggering the first net sales milestone payment of $5 million, which was earned and recognized in Q2 2023 revenue, and was received after quarter-end; net sales trend supports the potential to earn a second net sales milestone during 2023.Continued advancement of a Phase 2 clinical trial evaluating KP1077 as an investigational treatment for IH: Phase 2 IH trial is actively enrolling 48 adult patients with IH at more than 30 sites in the U.S. Interim Phase 2 data for the open-label titration phase of the trial are expected by the end of Q3 2023. Topline Phase 2 data in IH is expected to be reported in the first half of 2024 based on the pace of enrollment. Expanded the clinical program for KP1077 by opening an Investigational New Drug Application (IND) for narcolepsy, extending its potential to address multiple rare sleep disorders. Phase 1 clinical trial in healthy volunteers initiated during Q2 2023 and is currently enrolling.By leveraging the data from the IH program and the existing dataset generated as part of the AZSTARYS development program for serdexmethylphenidate (SDX), the sole active pharmaceutical ingredient in ...