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Ovid Therapeutics Inc. (NASDAQ: OVID) is a pioneering biopharmaceutical company dedicated to creating transformative medicines for patients and families affected by rare neurological disorders. The company’s primary focus is on developing treatments for conditions such as Angelman syndrome and Fragile X syndrome through its innovative drug candidates, OV101 and OV935.
OV101, Ovid’s lead drug candidate, is designed to address the symptoms of Angelman syndrome and Fragile X syndrome. The company has initiated the Phase 2 STARS trial to evaluate the efficacy of OV101 in adults with Angelman syndrome and is also conducting a Phase 1 trial in adolescents to identify suitable doses for younger patients. These efforts underscore Ovid’s commitment to advancing treatments for underserved communities.
In collaboration with Takeda Pharmaceutical Company Limited, Ovid is developing OV935 for the treatment of rare epileptic encephalopathies. This partnership aims to leverage both companies' strengths to accelerate the development of novel therapies. Ovid’s pipeline features a range of potential first-in-class and in-class mechanisms of action, highlighting the company's innovative approach to tackling rare epilepsies and seizure-related neurological disorders.
Ovid Therapeutics is also committed to maintaining transparency and fostering a supportive community. The company’s Community Guidelines, available on their website, outline their dedication to integrity and patient-focused values.
Recent corporate updates include the announcement of fourth-quarter and annual 2023 financial results and the first-quarter 2024 financial results, which provide insights into the company’s financial health and strategic direction. Ovid continues to make significant strides in its clinical and research pipeline, aiming to bring meaningful change to the lives of those affected by rare neurological disorders.
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.
Ovid Therapeutics (NASDAQ: OVID) announced an educational webinar on October 22, 2020, at 1:00 p.m. ET, focusing on Angelman syndrome and its OV101 development program. The event will feature experts discussing key topics such as tonic inhibition and treatment practices. The agenda includes presentations from Ovid’s leadership and external experts, highlighting the ongoing Phase 3 NEPTUNE trial for OV101. OV101 aims to treat Angelman and Fragile X syndromes, having received multiple designations from the FDA and the European Commission.
Ovid Therapeutics Inc. (NASDAQ: OVID) announced the presentation of four abstracts from its OV101 (gaboxadol) clinical development program at the CNS/ICNA 2020 Virtual Congress, held from October 12 to 23. These presentations include data from the Phase 2 ROCKET trial for Fragile X Syndrome and the STARS trial for Angelman Syndrome, focusing on seizure outcomes and caregiver insights. Ovid emphasizes its commitment to addressing unmet needs in neurological disorders, with OV101 being a potential first-in-class treatment targeting tonic inhibition disruptions in these conditions.
Ovid Therapeutics (NASDAQ: OVID) will present at the 2020 Cantor Fitzgerald Virtual Global Healthcare Conference on September 17, 2020, at 2:00 p.m. ET. The presentation aims to discuss the company’s commitment to developing transformative treatments for rare neurological diseases. Live access to the audio webcast will be available on the company’s website, with an archived replay post-event. Ovid’s key investigational medicine, OV101, is under development for Angelman and Fragile X syndromes, while OV935 is being developed in collaboration with Takeda for rare developmental and epileptic encephalopathies.
Ovid Therapeutics Inc. (Nasdaq: OVID) has priced an underwritten offering of 6,250,000 shares of its common stock at $8.00 per share. The offering, expected to close on August 27, 2020, will generate approximately $50 million in gross proceeds. Funds will primarily support the clinical development of OV935 for developmental and epileptic encephalopathies and OV101 for Angelman syndrome and Fragile X syndrome. The offering is managed by Cowen and William Blair, with RBC Capital Markets as lead manager.
Ovid Therapeutics and Takeda announced positive topline results from the Phase 2 ELEKTRA study of soticlestat, a treatment for Dravet syndrome (DS) and Lennox-Gastaut syndrome (LGS). The primary endpoint was achieved, showing a statistically significant 27.8% median reduction in seizures for DS patients compared to placebo (p=0.0007). LGS cohort results were numerically favorable but not statistically significant (p=0.1279). Soticlestat was well-tolerated with no new safety signals. The companies plan to initiate a Phase 3 program for soticlestat in DS, following successful outcomes.
Ovid Therapeutics has partnered with UConn to develop a next-generation short hairpin RNA (shRNA)-based therapeutic for Angelman syndrome, a genetic condition caused by the loss of UBE3A gene function. This collaboration aims to advance the shRNA therapy alongside Ovid's small molecule OV101, currently in Phase 3 trials. With the potential to restore UBE3A function, this initiative signifies Ovid's commitment to addressing the needs of individuals with Angelman syndrome, indicating a strategic shift in their research direction. Topline results for OV101 are expected in Q4 2020.
Ovid Therapeutics has partnered with Angelini Pharma to develop, manufacture, and market OV101 (gaboxadol) for Angelman syndrome in Europe and Russia. This agreement grants Ovid an upfront payment of $20 million and up to $212.5 million based on milestones, along with double-digit royalties on net sales. OV101 is currently in a pivotal Phase 3 trial with results expected in Q4 2020. Ovid retains all rights outside Europe. This collaboration aims to accelerate the drug's availability to patients with no approved treatment.
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