Ovid Therapeutics Inc. outlined key clinical and business priorities or 2019. 2018 Highlights and Anticipated 2019 Clinical and Regulatory Milestones. OV101 for Angelman Syndrome. A novel delta (d)-selective GABAA receptor agonist entering Phase 3 clinical development. Based on results announced in 2018 for the Phase 2 STARS clinical trial and discussion with the U.S. Food and Drug Administration (FDA) during an End-of-Phase 2 meeting, Ovid announced plans on December 6, 2018 to move ahead with a single pivotal Phase 3 trial of OV101 in pediatric patients with Angelman syndrome, called NEPTUNE, pending FDA concurrence on the study protocol and supporting framework and materials. If positive, NEPTUNE is intended to support a New Drug Application for OV101. In 2019, Ovid expects to achieve the following key milestones for its Angelman syndrome program: Enroll first patient in the ELARA trial, an open-label extension study, in the first quarter of 2019. Submit Phase 2 STARS clinical results for publication in a peer-reviewed medical journal. Finalize protocol and operational plans for Phase 3 NEPTUNE trial and submit to FDA in the first half of 2019. Initiate enrollment for Phase 3 NEPTUNE trial in the second half of 2019. Engage with European Medicines Agency (EMA) on OV101 clinical development plans. OV101 for Fragile X Syndrome In July 2018, Ovid initiated the Phase 2 ROCKET clinical trial, a randomized, double-blind, parallel-group trial to evaluate the safety, tolerability and efficacy of OV101 over 12 weeks in approximately 30 males with Fragile X syndrome aged 13 to 22 years. The SKY ROCKET trial was initiated in the third quarter of 2018 and is an observational study designed to provide additional data on the key endpoints being explored in the ROCKET trial. It is also designed to provide comparative data with the current standard of care. SKY ROCKET will enroll up to 30 males with Fragile X syndrome ages 5 to 30 years. In 2019, Ovid expects to achieve the following key milestones for OV101’s Fragile X syndrome program: Complete enrollment in Phase 2 ROCKET trial; announce data in second half 2019. Complete enrollment in Phase 2 SKY ROCKET; announce data in second half 2019. OV935 for Rare Developmental and Epileptic Encephalopathies (DEE) A potent, highly-selective, first-in-class inhibitor of the enzyme cholesterol 24-hydroxylase (CH24H) being investigated as a novel approach to treating epilepsy. OV935 is being developed in the context of a unique collaboration with Takeda Pharmaceutical Company Limited. The companies share 50% of all development expenses and potential future revenues. In a press release issued December 17, 2018, Ovid announced results from the Phase 1b/2a clinical trial of OV935 in 18 adults with rare DEE who had not been successfully treated with currently available treatment regimens. The trial achieved its primary endpoint of safety and tolerability, showing OV935 to be generally well tolerated. Exploratory efficacy analysis of OV935 showed progressive reduction over time in seizure frequency that was correlated with decreases in plasma 24-hydroxycholesterol (24HC) levels in adults across multiple DEE. Ovid expects to achieve the following key milestones in 2019 for the OV935 development program: Submit Phase 1b/2a clinical trial results for peer-review presentation at a scientific medical meeting in first half 2019. Engage with EMA on OV935 clinical development plans. Continue enrollment in ENDYMION open-label extension trial. Complete enrollment in the second half of 2019 in the Phase 2 ARCADE trial, an open-label trial evaluating patients 2 to 17 years of age diagnosed with CDKL5 deficiency disorder and Duplication 15q syndrome. Continue enrollment in Phase 2 ELEKTRA trial, a randomized, double-blind, placebo-controlled trial evaluating patients 2 to 17 years of age diagnosed with Dravet syndrome and Lennox-Gastaut syndrome. Continue to evaluate the potential for plasma 24HC to be a biomarker.