Lumateperone

Innovations in obesity, ovarian cancer vaccines, Alzheimer’s, and mental health drugs are transforming healthcare, with UK tech stocks and biotech sectors offering untapped investment opportunities. Key players include Intra-Cellular Therapies, Supernus Pharmaceuticals, and specialist providers like Bioventix and Diaceutics. Funds like Comgest Growth Europe ex UK and Polar Capital Global Healthcare Trust offer diversified healthcare exposure.

Lumateperone (Caplyta) showed significant efficacy in preventing relapse in schizophrenia patients in Study 304, with a 63% reduction in relapse risk compared to placebo. The treatment was well-tolerated, with headache being the most common adverse event.

KarXT (Cobenfy) was approved by the FDA for treating schizophrenia, marking the first new mechanism of action since 1954. Developed by Karuna Therapeutics, KarXT combines xanomeline and trospium to modulate brain circuits via a nondopaminergic mechanism. Clinical trials demonstrated significant improvements in symptoms, with KarXT not classified as an antipsychotic, differing from traditional D2R antagonists. Adverse events are mitigated by trospium's anticholinergic properties, and the drug has no boxed warnings. This approval introduces a novel neurotransmitter target for schizophrenia treatment.

Intra-Cellular Therapeutics reports positive Phase III data for Caplyta in preventing schizophrenia relapse, with a 63% reduction in relapse risk. Caplyta, Intra-Cellular's only marketed therapy, generated $462.2m in sales last year and is expected to reach $665m-$685m this year. GlobalData forecasts over $3bn in sales by 2030. Intra-Cellular plans to file an sNDA for Caplyta as an adjunct treatment for MDD in Q4 2024 and is evaluating it in pediatric patients with schizophrenia and bipolar disorders.

Intra-Cellular Therapies announced positive results from study 304, showing lumateperone (Caplyta) 42 mg effectively prevents relapse in schizophrenia patients, with a 63% reduction in relapse risk compared to placebo. Lumateperone was generally safe and well-tolerated, with a primary endpoint of longer time to first symptom relapse and a secondary endpoint of better treatment discontinuation rates.

Moderna's CEO steps down as sales chief, Intra-Cellular's Caplyta shows reduced relapse risk in schizophrenia, Vertex records first revenue from CRISPR gene therapy Casgevy, Syndax sells Niktimvo royalty rights to Royalty Pharma for $350M, and Nektar Therapeutics sells an Alabama facility to Ampersand Capital Partners for $90M.

Intra-Cellular Therapies reports positive results from a study on 42 mg lumateperone (Caplyta) for relapse prevention in schizophrenia. The study showed significant reduction in relapse risk (HR, 0.37; 95% CI, 0.22-0.65) and better safety compared to placebo. Lumateperone is FDA-approved for schizophrenia and bipolar depression.

CAPLYTA (lumateperone) demonstrated efficacy and safety as a maintenance treatment for schizophrenia in a randomized withdrawal trial, showing a statistically significant longer time to relapse compared to placebo (p=0.0002).

Intra-Cellular Therapies announced positive Phase 3 results for CAPLYTA (lumateperone) in preventing schizophrenia relapse, showing a 63% reduction in relapse risk vs. placebo (p=0.0002), with 16.4% of lumateperone patients relapsing vs. 38.6% in the placebo group. The drug was generally well-tolerated, with headache as the most common adverse event.