BRISTOL MYERS SQUIBB

Bristol Myers Squibb won dismissal of a $6.4 billion lawsuit claiming it delayed FDA approval for Breyanzi and two other drugs, as Judge Jesse Furman ruled UMB Bank was not properly appointed trustee for Celgene shareholders' contingent value rights (CVR).

The KRAS Inhibitors market is poised for significant growth driven by increasing cancer incidence, treatment access, and a robust pipeline. The market size in the 7MM was $500 million in 2023, expected to rise by 2034. KRAZATI (adagrasib) is projected to outperform LUMAKRAS (sotorasib) in revenue. The US leads in KRAS mutation cases in NSCLC, with 46% of 7MM cases. Competition in G12C NSCLC is intensifying, with Chinese biotechs entering the KRAS space. Despite G12D being the most prevalent KRAS variant, G12C is the primary target in colorectal cancer. KRAZATI is the first KRAS inhibitor approved for KRAS G12C-mutant colorectal cancer. Pancreatic cancer, with 60-90% KRAS mutations, presents a significant market opportunity. Pan-KRAS drugs, targeting multiple mutations, offer broad market potential. Key companies include Novartis, Roche, Genentech, and Mirati Therapeutics. Emerging therapies like JDQ443, Divarasib, and Avutometinib are expected to reshape the market. The KRAS inhibitor market is evolving, driven by high unmet needs, competitive drug development, and regulatory approvals.

FDA approves Cobenfy, a new schizophrenia drug that targets cholinergic receptors, potentially reducing hallucinations without weight gain or sluggishness. Cobenfy, priced at $1,850/month, showed symptom reduction in 5-week trials, but long-term effects remain uncertain.

Bristol Myers Squibb's COBENFY, a new oral medication for schizophrenia, received FDA approval and targets M1 and M4 receptors without blocking D2 receptors, offering a new treatment approach with fewer side effects. Expected to be available in the U.S. in mid-October, COBENFY aims to improve patient outcomes and treatment tolerance.

Preclinical data show engineered B cell medicines (BCMs) can produce sustained active levels of alkaline phosphatase (ALP), potentially treating Hypophosphatasia (HPP). Presented at the ASBMR 2024 Annual Meeting, the study used CRISPR/Cas9 and AI to modify human B cells for ALP expression, demonstrating BCMs' potential for once-yearly administration without pre-conditioning.

US FDA approves new schizophrenia drug Cobenfy, a major advance targeting cholinergic neurotransmitter system, potentially transforming lives of millions.

September saw FDA approvals for two Niemann-Pick Disease Type C drugs, an OTC hearing aid software, and upcoming October decisions include Biofrontera's Ameluz dosage increase, Zealand Pharma's Dasiglucagon for hypoglycemia, Bristol Myers Squibb's Opdivo for lung cancer, Amgen's LUMAKRAS for colorectal cancer, Camurus' Oclaiz for acromegaly, Iterum Therapeutics' Oral Sulopenem for UTIs, PharmaTher's Ketamine for anesthesia, and Lexicon Pharma's Zynquista for diabetes.

PureTech Health's KarXT, now marketed as Cobenfy, receives FDA approval for treating schizophrenia in adults, triggering $29m in payments from Royalty Pharma and Karuna Therapeutics. Cobenfy, developed by combining xanomeline with trospium chloride, aims to address tolerability issues in neuropsychiatric treatments. PureTech anticipates 2% royalties on net annual sales exceeding $2bn, with Cobenfy's success generating $1.1bn for the company, enabling self-funding of its pipeline, including LYT-100 for idiopathic pulmonary fibrosis.