BRISTOL MYERS SQUIBB

BMO Capital's Evan Seigerman maintains a Hold rating on Bristol-Myers Squibb, raising the price target to $53.00 from $48.00. The approval of COBENFY, a schizophrenia treatment without a black box warning, is seen as a significant upside, validating Bristol's acquisition strategy. Seigerman projects peak sales of $2.4 billion for schizophrenia and $3.9 billion for Alzheimer's disease psychosis, but remains cautious due to stable but fairly valued market performance and potential revenue impacts from COBENFY's lower-than-expected pricing.

FDA approves COBENFY, a new oral medication for schizophrenia in adults, marking the first new class of drugs for the disorder in decades. COBENFY, manufactured by Bristol Myers Squibb, is expected to be available in the U.S. in late October and works through a novel pathway in the brain, offering a new treatment option for patients.

Bristol-Myers Squibb's $14 billion acquisition of Karuna Therapeutics pays off with FDA approval for Cobenfy, a novel schizophrenia drug targeting cholinergic receptors. Cobenfy offers a new treatment approach with milder side effects compared to dopamine-blocking drugs, potentially leading to blockbuster sales. BMS plans to launch Cobenfy at $1,850 per month, with further clinical trials underway for additional indications.

The FDA approved Bristol Myers Squibb's Cobenfy, the first novel schizophrenia medication in decades, offering better tolerability and a new treatment approach by blocking muscarinic cholinergic receptors. Developed by Karuna Therapeutics, Cobenfy targets M1 and M4 receptors in the brain, avoiding peripheral side effects. Approved based on Phase 3 trials showing significant symptom reduction, it has gastrointestinal side effects but lacks a black box warning. Expected to be available in October, it may be prescribed for patients unresponsive to other antipsychotics.

FDA approves Bristol Myers Squibb's Cobenfy, a new antipsychotic drug for schizophrenia with fewer side effects. Meanwhile, lawsuits allege health issues from diabetes and weight loss drugs, and concerns rise over weight loss drugs causing eating disorders in teens. Prescription drug price hikes disproportionately affect Black patients, and the UN calls for action on antimicrobial resistance.

FDA approved BMS's Cobenfy, a first-in-class cholinergic receptor-targeting treatment for schizophrenia in adults, based on two 5-week, randomized, double-blind, placebo-controlled studies showing significant symptom reduction. Cobenfy offers a new pharmacological approach, potentially changing the treatment paradigm for schizophrenia, though it carries risks of urinary retention, increased heart rate, and liver damage.

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Bristol Myers Squibb and 2seventy bio halted the KarMMa-9 trial due to enrollment challenges, despite efforts to facilitate recruitment. Advances in induction therapies have reduced the eligible patient population for the trial. However, ide-cel (Abecma) received FDA approval for expanded use in relapsed/refractory multiple myeloma after two prior lines of therapy, based on positive results from the KarMMa-3 trial.

New schizophrenia treatment, Cobenfy, approved by FDA targets brain's acetylcholine levels, reducing side effects like drowsiness and weight gain, and could begin prescriptions in late October.

FDA approves Cobenfy, the first new schizophrenia medication in decades, targeting cholinergic receptors to reduce symptoms without typical side effects like weight gain and sluggishness.