Johnson & Johnson strengthens neuroscience leadership with acquisition of Intra-Cellular Therapies, Inc.
- Johnson & Johnson acquires Intra-Cellular Therapies for $14.6 billion, adding CAPLYTA to its portfolio.
- CAPLYTA is FDA-approved for bipolar I and II depression and schizophrenia, with a sNDA submitted for major depressive disorder.
- The acquisition includes a promising pipeline for generalized anxiety disorder and Alzheimer's disease-related psychosis.
- The transaction is expected to close later this year, pending regulatory and stockholder approvals.
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Sage Therapeutics receives acquisition proposal from Biogen
- Biogen has submitted a nonbinding proposal to acquire all outstanding shares of Sage Therapeutics for $7.22 per share.
- Sage's Board of Directors will review the proposal with independent financial and legal advisors.
- There is no assurance that a transaction will occur as a result of this proposal.
- Sage shareholders are advised that no action is required at this time.
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Arrivo BioVentures announces positive results from qEEG and BNA study of SP-624 on neural brain activity related to depression and cognition
- Arrivo BioVentures reported positive data from the SP-624-103 study, focusing on SP-624's impact on neurological pathways.
- The study is a double-blind, placebo-controlled trial with three cohorts, currently enrolling patients with major depressive disorder (MDD).
- Cohort 1 results showed increased beta power and decreased delta power, indicating enhanced synaptic plasticity and reduced depressive states.
- The study supports SP-624's potential in treating MDD and other cognitive disorders, with further exploration in a Phase 2b/3 study.
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Vistagen initiates fasedienol repeat dose study for social anxiety disorder
- Vistagen has started a Phase 2 repeat dose study of fasedienol, a nasal spray for social anxiety disorder (SAD).
- The study is a multi-center, randomized, double-blind, placebo-controlled trial with three dosing arms.
- The trial aims to assess the efficacy, safety, and tolerability of fasedienol during a public speaking challenge.
- This study complements ongoing Phase 3 trials and could support a future New Drug Application (NDA) to the U.S. FDA.
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Ocugen announces positive 2-year data from phase 1/2 trial of OCU400 for retinitis pigmentosa
- OCU400 demonstrated improvement or preservation in visual function in 100% of treated subjects over two years.
- Statistically significant improvement in low-luminance visual acuity was observed, validating the gene-agnostic mechanism.
- No serious adverse events related to OCU400, indicating a favorable safety profile.
- Phase 3 OCU400 liMeliGhT trial is ongoing, with a BLA submission expected in the first half of 2026.
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Universal Brain publishes groundbreaking depression research
- Universal Brain's study introduces a novel framework using multiple event-related potentials (ERPs) to predict depression remission.
- The research combines EEG paradigms with statistical analyses to subtype depression for personalized treatment.
- Findings highlight the potential for individualized treatment pathways in precision psychiatry.
- The study bridges laboratory assessments with real-world clinical practice, aiming to improve depression management.
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Merus and Biohaven announce collaboration to co-develop three novel bispecific ADC programs
- Merus and Biohaven have entered a collaboration to develop three bispecific antibody drug conjugates (ADCs).
- The collaboration leverages Merus' Biclonics technology and Biohaven's ADC conjugation and payload platforms.
- Biohaven will handle preclinical ADC generation, while Merus will focus on bispecific antibody generation.
- The agreement includes shared development and commercialization costs upon mutual advancement of each program.
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