BRISTOL MYERS SQUIBB

Despite numerous challenges, 2seventy bio, formerly part of bluebird bio, remains focused on achieving profitability with its CAR T therapy Abecma. The company has undergone layoffs, pipeline reorganizations, and faced competition and FDA safety warnings. CEO Chip Baird predicts profitability next year, with potential growth strategies including acquisitions or licensing deals. The company's culture and resilience among its employees have been key to its survival.

Cassava Sciences misled investors with falsified Alzheimer’s drug data; FDA action needed. Major biotech events this quarter include Amgen, Novo Nordisk, and AbbVie drug readouts. Triveni Bio raises $115 million for immunology treatments. Eli Lilly considers obesity drug testing for prevention, similar to Novo Nordisk. Lilly invests $4.5 billion in a research and manufacturing hub.

Bristol Myers Squibb's Cobenfy approved as first novel schizophrenia treatment in 35 years; Pfizer withdraws sickle cell drug Oxbryta; Roche's Pharma Day highlights $850M CDK inhibitor acquisition and $3.6B in projected sales; BioSpace examines potential impact of new abortion and IVF laws on women's health research.

The FDA approved Cobenfy, a new schizophrenia treatment targeting the cholinergic system, developed by Karuna Therapeutics and acquired by Bristol Myers Squibb. Cobenfy, combining xanomeline with an overactive bladder drug, significantly reduces schizophrenia symptoms without severe side effects, potentially transforming treatment options.

De-escalation strategies for HPV-positive oropharyngeal cancer failed to show noninferiority compared to standard care, resetting the bar for future trials. Standard treatment with 70 Gy RT plus cisplatin achieved 98.1% 2-year PFS, while de-escalated strategies with 60 Gy RT plus cisplatin or nivolumab yielded 88.6% and 90.3% PFS, respectively. Future de-intensification studies must be more selective and effective.

Exscientia presented at ELRIG Drug Discovery 2024 on using AI and robotics for drug discovery, noting an 80% Phase I success rate for AI-designed molecules. The company's system focuses on flexibility rather than high-throughput screening, aiming to increase productivity without replacing human roles.

WuXi AppTec’s Dr Dave Madge predicts peptide-based radiotherapeutics could surpass antibody-based counterparts due to advantages like tissue penetration and low toxicity. Despite only two antibody-based radiopharmaceuticals being FDA-approved, the radiopharmaceutical space has seen significant deals, with theranostic radiopharmaceuticals combining diagnostics and therapy gaining traction. WuXi’s expansion in peptide manufacturing aims to meet global demand, but potential restrictions from the US BIOSECURE Act pose a challenge.

Volastra Therapeutics announced FDA Fast Track designation for VLS-1488, a KIF18A inhibitor for platinum-resistant high-grade serous ovarian cancer, reflecting its potential to address unmet medical needs.

FDA approves Bristol Myers Squibb's COBENFY (xanomeline and trospium chloride), a first-in-class muscarinic agonist for schizophrenia, targeting M1 and M4 receptors without blocking D2 receptors, offering a new treatment option.

Pharma companies like Novo Nordisk, Viking Therapeutics, Amgen, CRISPR Therapeutics, and Moderna are set to announce clinical trial results for next-gen weight loss drugs, cancer and autoimmune therapies, and potential new products beyond COVID-19 vaccines by year-end.