Business
Ovid Therapeutics Reports Business Updates, Fourth Quarter and Full Year 2023 Financial Results
Two pivotal Phase 3 clinical trials studying soticlestat as a treatment for Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) completed enrollment;
About this update from Ovid Therapeutics Inc.
[{"type":"text","content":"Two pivotal Phase 3 clinical trials studying soticlestat as a treatment for Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) completed enrollment; Takeda anticipates topline data readout by or before September 2024OV888 (GV101) is progressing on-track in a Phase 1, double-blind, multiple-ascending dose trial; a higher dose cohort has been added and no serious adverse events have been observed Feedback from a pre-IND session with the FDA supports potential initiation of a Phase 2 study of OV888 (GV101) in the second half of 2024Phase 1 study with OV329 continues to progress; data expected in the second half of 2024Cash, cash equivalents and marketable securities of $105.8 million as of December 31, 2023; expected to support runway into first half of 2026 NEW YORK, March 08, 2024 (GLOBE NEWSWIRE) -- Ovid Therapeutics Inc. (NASDAQ: OVID), a biopharmaceutical company dedicated to meaningfully improving the lives of people affected by rare epilepsies and brain conditions, today reported business updates and financial results for the fourth quarter and year ended December 31, 2023. “Ovid is progressing well and we are excited. This year we anticipate five clinical and regulatory milestones from our pipeline of novel compounds. Our ROCK2 collaboration with Graviton Bioscience is producing results faster than expected. We look forward to initiating a Phase 2 study of OV888 (GV101) in cerebral cavernous malformations (CCM) in the second half of this year. By year end 2024, we expect to deliver biomarker data from our oral OV329 program and investigational new drug submissions for intravenous formulations of both OV329 and OV350,” said Dr. Jeremy Levin, D. Phil, MB Chir, Chairman and CEO of Ovid. “Importantly, the first potential rare epilepsy medicine that Ovid helped shape, soticlestat, is expected to have two pivotal Phase 3 study topline readouts by Takeda. If the trials are successful, we believe a new and important medicine will be available to LGS and DS patients in 2025. If approved and successfully commercialized, Ovid will be eligible to receive regulatory and sales milestone payments as well as royalties on all future sales of soticlestat,” Dr. Levin added. Pipeline Updates Ovid anticipates five clinical and regulatory milestones this year from its own pipeline. In addition, Takeda is expected to read out results from two...