BRISTOL MYERS SQUIBB

KarXT, a new antipsychotic targeting muscarinic receptors, received US approval, offering potential for more effective and better-tolerated schizophrenia treatment. It modulates dopamine release and improves cognitive function without severe side effects, marking a shift in psychosis treatment. Future drugs may further refine this approach, tailoring treatment to individual needs.

FDA approves Bristol Myers Squibb's Cobenfy, the first novel schizophrenia treatment in over 70 years, expected to be available in late October. The twice-daily pill, acquired from Karuna Therapeutics for $14 billion, offers a new mechanism of action without direct dopamine blocking, aiming to reduce side effects. Cobenfy's annual cost is $22,500, with a program to aid affordability. The drug may also be tested for Alzheimer's psychosis, bipolar mania, and autism-related irritability.

FDA approves KarXT, a new schizophrenia treatment by Bristol Myers Squibb, offering improved symptoms and fewer side effects. KarXT, a combination of Xanomeline and trospium, targets muscarinic receptors and reduces digestive issues. The drug is expected to be cost-effective if priced between $16,000 and $20,000 per year, with 75% of patients seeing symptom improvement by 30% or more after one year.

FDA approves Cobenfy, first new schizophrenia drug in over 30 years, combining xanomeline and trospium chloride to manage symptoms via a different mechanism targeting acetylcholine, potentially reducing common side effects like weight gain and drowsiness.

The FDA approved Cobenfy, a new schizophrenia treatment targeting muscarinic receptors, developed by Karuna Therapeutics and sold by Bristol Myers Squibb.

BMS and 2seventy bio halt Phase III KarMMa-9 trial for Abecma in NDMM due to reduced eligible patient population as induction therapies improve, affecting trial viability.

The FDA’s ODAC voted 11 to 1 against the risk:benefit profile of anti–PD-1 antibodies in first-line treatment of metastatic or unresectable esophageal squamous cell carcinoma (ESCC) with PD-L1 expression < 1. Data from KEYNOTE-590, CheckMate 648, and RATIONALE-306 trials showed marginal or no benefit in patients with PD-L1 < 1 tumors, with efficacy questioned in PD-L1–low populations.

The FDA’s Oncologic Drug Advisory Committee (ODAC) voted 11 to 1 against the use of checkpoint inhibitors (CPIs) in patients with metastatic or unresectable esophageal squamous cell carcinoma with PD-L1 expression less than 1, citing unfavorable risk-benefit assessment. The discussion focused on data from trials supporting the approvals of nivolumab, pembrolizumab, and tislelizumab, which showed marginal or unfavorable outcomes in patients with PD-L1 expression under 1, with higher benefits observed in those with expression over 1. The notable risks of CPIs, including immune-mediated adverse effects, were also highlighted.

The FDA's ODAC voted 10-2 against PD-1 inhibitors in first-line HER2-negative, MSS gastric/GEJ adenocarcinoma with PD-L1 < 1, citing unfavorable risk:benefit. Data from CheckMate 649, KEYNOTE-859, and RATIONALE-305 trials showed OS benefits in higher PD-L1 subgroups, but not in those with PD-L1 < 1, raising concerns over toxicity and cost.

Tulisokibart, an anti-TL1A monoclonal antibody, outperformed placebo in inducing clinical remission at week 12 in moderate to severe ulcerative colitis, according to the ARTEMIS-UC trial. The study incorporated a predictive biomarker for response, showing significant clinical remission, endoscopic improvement, and clinical response in patients on tulisokibart compared to placebo. A phase 3 program is planned to confirm these results.