BRISTOL MYERS SQUIBB

FDA approves Bristol Myers Squibb's Cobenfy, a first-in-class schizophrenia drug targeting cholinergic receptors, offering a new treatment option with fewer side effects. Cobenfy, originally developed by Karuna Therapeutics, is expected to generate $2.99bn in sales by 2030. The drug's approval marks the first new approach to schizophrenia treatment in decades, addressing both positive and negative symptoms.

FDA approves Cobenfy (xanomeline and trospium chloride), the first new class of medicine in decades for treating schizophrenia, targeting cholinergic receptors instead of dopamine receptors.

The FDA approved xanomeline and trospium chloride (Cobenfy) for schizophrenia in adults, marking the first new drug class for the condition in over 30 years. Unlike antipsychotics, Cobenfy targets M1 and M4 muscarinic receptors, potentially benefiting patients who do not respond to dopamine-blocking agents. The drug showed significant reductions in Positive and Negative Syndrome Scale (PANSS) scores in phase III trials and has fewer common side effects compared to typical schizophrenia agents. Cobenfy is contraindicated in certain patient groups and should be discontinued if liver disease symptoms appear. It is expected to launch in late October.

Bristol Myers Squibb's shares surge as FDA approves its new schizophrenia drug, the first in 30 years.

The FDA approved Cobenfy, a new antipsychotic medication for schizophrenia, developed by Karuna Therapeutics. Despite its efficacy in clinical trials, concerns about insurance coverage and high list price ($22,500/year) may limit patient access. Bristol Myers Squibb, which acquired Karuna, plans to expand Cobenfy's use to bipolar disorder and Alzheimer's agitation, with ongoing studies.

J&J's Talvey shows promise in multiple myeloma trials; FDA advisory committee votes against cancer immunotherapy use in certain digestive tract cancers; AbbVie's acquisition of Cerevel Therapeutics yields positive Parkinson's drug results; Roche's Gazyva succeeds in lupus nephritis Phase 3 study; Biogen terminates agreement with Sage Therapeutics over failed essential tremor drug; Enanta Pharmaceuticals' EDP-323 shows rapid antiviral effect against RSV.

FDA approved Cobenfy, a new schizophrenia treatment targeting the cholinergic system, after 30 years without new options. Developed by Karuna Therapeutics and acquired by Bristol Myers Squibb, Cobenfy aims to reduce symptoms like hallucinations and delusions with fewer side effects compared to dopamine-based treatments.

The FDA approved Cobenfy, the first schizophrenia drug targeting cholinergic receptors, offering a new treatment option for 2.8 million Americans. Cobenfy showed significant symptom reduction in five-week studies, but common side effects include nausea, hypertension, dizziness, and gastrointestinal issues.

FDA approved xanomeline and trospium chloride (Cobenfy) for schizophrenia, marking the first new class of medication in decades. The drug targets M1 and M4 receptors without blocking D2 receptors, supported by EMERGENT clinical program data showing significant symptom reduction. Common side effects include nausea and hypertension.

FDA approves first new drug for schizophrenia in 70 years, targeting muscarinic acetylcholine receptors, offering hope to patients unresponsive to existing treatments. Cobenfy demonstrated symptom reduction in 5 weeks, though it comes with side effects like nausea and is contraindicated for certain medical conditions.