Eli Lilly and Co

Schizophrenia symptoms are linked to dopamine dysregulation, with current antipsychotics targeting D2 receptors. Clozapine, binding to different receptors, showed promise but faced side effects. Research on muscarinic receptors (M1 and M4) revealed their importance in cognitive functions and perception. Xanomeline, initially for Alzheimer’s, was tested for schizophrenia but caused unacceptable side effects. Karuna Therapeutics combined xanomeline with trospium, creating Cobenfy, which addresses positive, negative symptoms, and cognitive issues without severe side effects. Cobenfy’s approval highlights the value of basic research despite long timelines.

Kailera Therapeutics, backed by Atlas Venture, Bain Capital, RTW Investments, and Lyra Capital, emerges with a $400M Series A to develop GLP-1 drugs for obesity and metabolic conditions. Acquired from Jiangsu Hengrui Pharmaceuticals, KAI-9531, targeting GLP-1 and GIP receptors, is in clinical trials for obesity and Type 2 diabetes. Led by CEO Ron Renaud and board chair John Milligan, Kailera aims to advance next-generation treatments for chronic weight management.

The UC market saw significant advancements with FDA approvals for AbbVie's Skyrizi and Johnson & Johnson's Tremfya. A Spherix survey revealed Skyrizi's rapid adoption and positive efficacy perceptions, capturing double the market share of Omvoh. Skyrizi's on-body injector received moderate to high satisfaction. With three IL-23 inhibitors now available, Spherix will monitor market dynamics to identify the preferred treatment.

The FDA approved Cobenfy, a new schizophrenia treatment combining xanomeline and trospium, representing a 30-year collaborative effort involving Monash University researchers. This marks the first major advancement in schizophrenia treatment in decades, offering a more targeted approach than traditional dopamine-focused drugs.

Major money fuels efforts to expedite the next significant obesity company to market, with Metsera launching in April.

S.B., A.D., T.J.F., I.M.G., L.G., R.K.J., G.K., J.M.L., G.V.L., K.P.-J., H.I.S., J.T., R.R.W., M.W., Y.L.W. have disclosed various financial interests, including funding, advisory roles, patents, and equity. C.M.B., E.B., M.W.B., and K.P. declare no competing interests.

Eli Lilly considers lowering BMI threshold for weight-loss drug trials, potentially expanding use to individuals at risk of weight gain or health issues like diabetes, despite market challenges and competition.

Tonix Pharmaceuticals aims to lead in non-addictive pain management with TNX-102 SL, a non-opioid drug targeting fibromyalgia. The FDA's Fast Track designation highlights the need for new treatments. Tonix is nearing NDA submission for TNX-102 SL, which could offer a new pharmacotherapy for fibromyalgia after 15 years. The push for non-addictive painkillers is driven by the opioid crisis and government initiatives like the HEAL Initiative. Vertex's VX-458, also under Priority Review, addresses acute pain. Both drugs represent crucial steps in reducing opioid reliance.

Demand for weight-loss drugs drives Eli Lilly and Novo Nordisk's stock prices. Structure Therapeutics, a biopharmaceutical company, develops GSBR-1290, an oral GLP-1R agonist for diabetes and obesity. Morgan Stanley initiated coverage with an 'overweight' rating, projecting GSBR-1290 to reach $6.3 billion in global sales by 2040. Analysts have a 'strong buy' rating for GPCR stock, with an average 12-month price target of $87.40.

Roche plans to introduce 20 new drugs to address major diseases, aiming to double patient usage by 2029. The company seeks to improve late-stage trial success rates and enters the weight-loss drug market. Focus areas include cardiovascular, ophthalmology, immunology, neurology, cancer, and hematology.