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- Ovid Therapeutics announced multiple strategic executive appointments to support its advancing pipeline of neurological and neuropsychiatric medicines. - Kevin Norrett, with over 30 years of life sciences leadership, joins as Chief Business Officer to spearhead strategic partnerships and corporate development. - Charles Carter has been promoted to Chief Financial Officer, succeeding Jeffrey Rona who transitions to a long-term advisory role through 2027. - Eliseo Salinas, MD, joins as Executive R&D Advisor, bringing experience from 15 international regulatory approvals in neuropsychiatric drug development.
- Jeremy Levin, former Teva CEO and Ovid Therapeutics founder, argues in his new book that U.S. biotech leadership faces threats from weakening institutions like the FDA, CDC, and NIH. - Levin contends that short-term venture capital thinking is distorting R&D priorities, with investors demanding de-risked assets rather than funding the most important scientific questions. - China is poised to overtake the U.S. in drug development, aided by American pharma companies seeking innovation and acquisitions there, Levin warns. - Levin calls for supply chain diversification in critical therapies, cautioning that concentration of drug manufacturing in China poses a genuine national security risk.
- Ovid Therapeutics successfully completed a Phase 1 study of OV350, the first-ever direct activator of KCC2 (potassium-chloride cotransporter 2) tested in humans, demonstrating good safety profile with no treatment-related serious adverse events. - The study achieved pharmacologically active concentrations and showed exploratory qEEG findings consistent with expected KCC2 modulation effects in the brain, supporting the therapeutic potential of this novel mechanism. - Results support advancement of Ovid's oral KCC2 direct activator portfolio, with OV4071 planned for Phase 1/1b trials in Q2 2026 targeting psychosis in Parkinson's disease and Lewy body dementia. - The company also appointed Dr. Petra Kaufmann as Chief Medical Officer, bringing extensive CNS drug development experience from Novartis Gene Therapies and leadership in Zolgensma's global approval.
- Ovid Therapeutics' next-generation GABA-AT inhibitor OV329 demonstrated strong target engagement and superior safety profile compared to vigabatrin in Phase 1 trials with 68 participants. - The company plans to initiate Phase 2a studies for drug-resistant focal onset seizures in Q2 2026, supported by comprehensive ophthalmic evaluations showing no retinal toxicity. - Ovid secured $175 million in financing to advance its pipeline through 2028, including first-in-class KCC2 direct activators for neuropsychiatric conditions. - Leadership transition announced with Meg Alexander becoming CEO in January 2026, while co-founder Jeremy Levin transitions to Executive Chairman role.
- Ovid Therapeutics announced positive topline results from its Phase 1 study of OV329, a next-generation GABA-aminotransferase inhibitor targeting drug-resistant epilepsies. - The study demonstrated significant GABAergic inhibition and strong safety outcomes in 68 healthy volunteers, marking a clinical milestone for the company. - The positive results attracted new institutional investors through a substantial private placement and led to a 6.4% increase in stock price. - OV329's early GABAergic efficacy and favorable safety profile represent potential advancement in treating drug-resistant epilepsies, though the company faces ongoing challenges with profitability and capital needs.
- Ovid Therapeutics announced a private investment in public equity (PIPE) financing expected to generate up to $175 million in gross proceeds, with an initial closing of approximately $81 million. - The funding will support the company's research and development activities, including advancement of its CNS drug pipeline featuring OV329, OV350, and OV4071 candidates targeting neurological disorders. - The financing includes participation from prominent new investors such as Janus Henderson Investors, RA Capital Management, and Blue Owl Healthcare Opportunities, alongside existing stakeholders. - The company expects its cash resources will fund operations into 2028, providing runway for clinical development of treatments for brain conditions with significant unmet medical need.
- Ovid Therapeutics announced positive Phase 1 results for OV329, a next-generation GABA-aminotransferase inhibitor, showing 53% inhibition of GABA-AT at 5 mg dose with statistical significance (p=0.0001). - The drug demonstrated superior or comparable efficacy to vigabatrin, the current first-generation GABA-AT inhibitor, while showing a favorable safety profile without ophthalmic complications. - OV329 successfully penetrated the brain and engaged its target, with biomarker studies confirming increased GABA levels and inhibitory activity across multiple validated measures. - The company plans to advance OV329 into Phase 2a trials for drug-resistant focal onset seizures in Q2 2026, targeting a significant unmet medical need in epilepsy treatment.
- 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. - The transaction provides non-dilutive funding to support Ovid's ongoing operations, while Immedica strengthens its focus on ganaxolone by acquiring additional intellectual property rights. - Ganaxolone is an approved medicine in the EU, Great Britain, US, and China for treating epileptic seizures associated with CDKL5 deficiency disorder in patients aged 2-17 years. - Immedica will also assume financial responsibility for all costs related to the licensed intellectual property portfolio and plans to expand the license to include additional indications.
- 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. - The company has strengthened its leadership team with biotech pioneer Dr. Stelios Papadopoulos joining the Board of Directors and two industry veterans taking key management positions as Ovid prepares for critical clinical development phases. - With $53.1 million in cash and equivalents as of December 31, 2024, Ovid expects to support operations and development programs into the second half of 2026, during which multiple pipeline and regulatory milestones are anticipated.
