Eli Lilly and Co

Sagimet Biosciences' SGMT stock rose 12.6% after FDA granted breakthrough therapy designation to denifanstat for treating MASH, a severe liver disease. Denifanstat, an oral pill, showed significant fibrosis reduction and delay in cirrhosis progression in phase IIb study. Sagimet plans to initiate phase III program by end of 2024. Currently, Madrigal Pharmaceuticals' Rezdiffra is the only approved MASH treatment.

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Eli Lilly invests USD 4.5 billion in a new Indiana plant to produce drugs for future clinical trials, aiming to strengthen its supply chain.

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.

Eli Lilly plans to invest $4.5 billion in a new facility, the Lilly Medicine Foundry, in Lebanon, Indiana, to advance research and manufacturing technologies. The facility aims to innovate manufacturing processes, reduce costs, and minimize environmental impact, with production capabilities ranging from small-molecule drugs to biologics and nucleic acid therapies. This investment brings Lilly's total commitment to the LEAP district to over $13 billion and its U.S. capital commitment since 2020 to more than $23 billion.

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.

Eli Lilly to invest $4.5 billion in Lilly Medicine Foundry, a new advanced manufacturing and drug development center in Indiana, set to open in late 2027, boosting Lilly's total U.S. investment to over $23 billion since 2020.

Kailera Therapeutics, backed by $400 million, aims to develop next-gen obesity drugs targeting GLP-1 and GIP, similar to Eli Lilly's Zepbound. Kailera's lead drug, KAI-9531, showed promising Phase 2 results in China, with 53.1% of patients losing 15%+ body weight at the highest dose. The company's pipeline includes oral therapies and a triple-target injectable drug, positioning it competitively in the metabolic disorder treatment field.