Ovid Therapeutics Inc. - OVID STOCK NEWS

Ovid Therapeutics (NASDAQ: OVID) announced the appointment of Professor Robert S. Langer, Sc.D., as Chairman of its Scientific Advisory Board. Dr. Langer, a prominent figure in the neurosciences with significant awards and recognitions, will guide Ovid's strategy toward addressing key scientific challenges in rare neurological disorders.

His leadership is expected to enhance Ovid’s pipeline of innovative treatments, leveraging his extensive experience in drug development and biotechnology.

Ovid Therapeutics (NASDAQ: OVID) announced a strategic shift focusing on developing its early-stage pipeline, including OV882 for Angelman syndrome, while discontinuing OV101 for Angelman and Fragile X syndromes due to insufficient efficacy results. The company also highlighted its agreement with Takeda, securing $196 million and potential milestones totaling $660 million for the soticlestat program, which it retains financial interest in. Ovid expects quarterly operating expenses between $8 million and $10 million starting in Q2 2021, supported by over $250 million in cash and investments as of December 31, 2020.

Ovid Therapeutics has closed a significant agreement with Takeda Pharmaceutical for the global development and commercialization of soticlestat, aimed at treating developmental and epileptic encephalopathies. Ovid received an upfront payment of $196 million and can earn up to $660 million in milestone payments. Additionally, Ovid will receive royalties of up to 20% on soticlestat's sales. This transition eliminates Ovid's financial obligations to Takeda under the previous collaboration, allowing Ovid to focus on its innovative pipeline targeting rare neurological disorders.

Ovid Therapeutics announced a significant transaction with Takeda to transfer global rights for soticlestat, with potential payments of up to $856 million. Ovid will receive $196 million upfront and could earn additional milestone payments, including royalties on sales. The partnership allows Takeda to conduct pivotal Phase 3 trials for Dravet and Lennox-Gastaut syndromes, projected to start in Q2 2021 and aims for commercial availability by 2024. Ovid anticipates a reduction in cash expenditures post-transaction, with expected operating expenses between $8 million and $10 million quarterly.

Takeda Pharmaceutical Company and Ovid Therapeutics announced an exclusive agreement for Takeda to gain global rights to develop and commercialize soticlestat for treating developmental and epileptic encephalopathies, including Dravet syndrome and Lennox-Gastaut syndrome. Takeda will pay Ovid $196 million upfront and could pay up to $660 million in milestones. This agreement relieves Ovid from further financial obligations related to the original collaboration. Phase 3 studies are set to begin in Q2 2021, building on positive Phase 2 ELEKTRA study results.

Ovid Therapeutics Inc. (NASDAQ: OVID) has been added to the Nasdaq Biotechnology Index, effective December 21, 2020. The Nasdaq Biotechnology Index includes securities listed on the NASDAQ that are classified as biotechnology or pharmaceutical. Ovid is focused on developing treatments for rare neurological diseases, with OV935 (soticlestat) expected to enter pivotal trials in 2021. Additionally, they are evaluating OV101 (gaboxadol) for Angelman and Fragile X syndromes.

Ovid Therapeutics (NASDAQ: OVID) announced that it will pause the OV101 program for Angelman syndrome after the Phase 3 NEPTUNE trial failed to meet its primary endpoint. While patients receiving OV101 showed a minimal improvement on the Clinical Global Impression-Improvement-Angelman syndrome scale (0.7 points vs. 0.8 points for placebo), secondary endpoints showed no significant differences. Despite the setback, OV101 was well-tolerated. The focus will shift to developing OV935 for Dravet and Lennox-Gastaut syndromes, with pivotal trials expected to start in H1 2021.

Ovid Therapeutics (NASDAQ: OVID) announced that abstracts from its clinical studies on soticlestat (TAK-935/OV935) for Dravet syndrome and Lennox-Gastaut syndrome, along with gaboxadol (OV101) for Angelman syndrome, will be presented at the upcoming American Epilepsy Society 2020 Virtual Congress from December 4-8, 2020. The company aims to address significant unmet needs in these neurological conditions. Both studies are part of Ovid's commitment to developing innovative treatments for rare neurological diseases.

Ovid Therapeutics reported third-quarter 2020 financial results, achieving revenue of $6.9 million versus zero a year prior, largely due to a $20 million upfront payment from Angelini Pharma. A net loss of $16.4 million was reported, slightly better than $16.6 million the previous year. Key pipeline developments include positive interim results from the ELEKTRA and ARCADE trials for soticlestat, and progress on the NEPTUNE trial for OV101 in Angelman syndrome, with topline data expected in Q4 2020.