Ovid Therapeutics Inc Stock Price, News & Analysis

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.

Ovid Therapeutics (NASDAQ: OVID) announced that the FDA has granted Rare Pediatric Disease Designation to OV101 (gaboxadol) for treating Angelman syndrome. OV101 is undergoing a pivotal Phase 3 trial (NEPTUNE) with topline results expected in Q4 2020. The FDA has previously provided Orphan Drug and Fast Track designations for OV101. If approved, Ovid may receive a priority review voucher. Angelman syndrome affects approximately 1 in 12,000 to 1 in 20,000 individuals globally, with no approved therapies available currently.

Ovid Therapeutics has announced a strategic multiyear research collaboration with Columbia University Irving Medical Center to develop genetic-based therapies for rare neurological disorders. The partnership, led by genetics expert Dr. Wendy K. Chung, aims to expand Ovid's drug development portfolio, focusing on conditions such as KIF1A-associated neurological disorder. This collaboration complements Ovid's existing clinical programs and supports their commitment to transforming treatment options for patients with rare neurological diseases.

Ovid Therapeutics Inc. (NASDAQ: OVID) announced that President and Chief Medical Officer Amit Rakhit, M.D., MBA, will participate in a fireside chat at the 2020 RBC Capital Markets Virtual Global Healthcare Conference on May 19 at 1:20 p.m. ET. This session aims to discuss the company's commitment to developing transformative medicines for rare neurological diseases. Ovid's pipeline includes the investigational medicine OV101 for Angelman syndrome and Fragile X syndrome, and OV935 for rare developmental and epileptic encephalopathies in collaboration with Takeda. Details will be available through their website.

Ovid Therapeutics (NASDAQ: OVID) announced positive topline results from the Phase 2 ROCKET trial of OV101, a GABAA receptor agonist targeting Fragile X syndrome, which has no approved therapies. The trial met its primary objective of safety and tolerability over 12 weeks, with no serious adverse events reported. Secondary results showed statistically significant reductions in behavioral symptoms: a 26.2% improvement in the Aberrant Behavior Checklist and a 21.6% improvement in the Anxiety, Depression and Mood Scale. Ovid is now evaluating dosing options and planning further discussions with regulators.