OVID THERAPEUTICS INC

Ovid Therapeutics has entered into a definitive agreement with Immedica Pharma AB to sell its future royalty rights for ganaxolone sales outside China for $7 million in cash.

• Peter Marks, head of FDA's Center for Biologics Evaluation and Research since 2016, was forced to resign after refusing to support HHS Secretary Robert F. Kennedy Jr.'s vaccine safety claims. • The departure triggered significant stock declines for gene therapy and vaccine-focused companies including Taysha, Solid Biosciences, Sarepta and Novavax, with shares falling 5-10%. • Industry leaders express concern that FDA's scientific independence is under threat, with BMO Capital Markets analysts calling the resignation "a significant negative for the biopharma and biotech sectors." • Marks' exit follows other key FDA departures, including CDER head Patrizia Cavazzoni, raising questions about regulatory stability and the future of accelerated approvals for innovative therapies.

Ovid Therapeutics is advancing its pipeline of neurological treatments, with topline results from OV329's Phase 1 study for drug-resistant epilepsies expected in Q3 2025 and first-in-human studies for KCC2 activator OV350 initiated in Q1 2025.

• A new report offers an overview of the clinical trial landscape for Dravet Syndrome, also known as Severe Myoclonic Epilepsy of Infancy, providing key data and analysis. • The review includes data on trial numbers, average enrollment, and top countries involved, segmented by region, phase, status, endpoints, and sponsor type. • Key companies like Jazz Pharmaceuticals, UCB, Takeda, and others are profiled, with details on their ongoing trials and prominent drugs in development for Dravet Syndrome. • The report identifies trends in clinical trial enrollment over the past five years and highlights recent news related to Dravet Syndrome research and development.