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NVO Stock Plunges as Obesity Drug CagriSema Misses Target in Phase III
NVONovo Nordisk(NVO) ZACKS·2024-12-23 16:00

Merck's Entry into Obesity Market - Merck announced plans to in-license global rights to an investigational oral GLP-1 receptor agonist, HS-10535, from Hansoh Pharma, marking its entry into the obesity market [1] - Merck will pay 112millionupfrontandupto112 million upfront and up to 1.9 billion in milestone payments and royalties for exclusive global rights, with Hansoh retaining co-promotion or sole commercialization rights in China [1] - Oral GLP-1 receptor agonists like HS-10535 could improve patient convenience and potentially reduce costs if approved as weight loss drugs [1] Novo Nordisk's CagriSema Performance - CagriSema, a combination of cagrilintide 2.4 mg and Wegovy, achieved 22.7% weight loss in the phase III REDEFINE 1 study, outperforming cagrilintide 2.4 mg (11.8%), Wegovy (16.1%), and placebo (2.3%) [2] - 40.4% of CagriSema patients achieved ≥25% weight loss, compared to 6% with cagrilintide 2.4 mg, 16.2% with Wegovy, and 0.9% with placebo [2] - CagriSema demonstrated a 20.4% weight loss regardless of treatment adherence, with mild to moderate gastrointestinal adverse events [3] Competitive Landscape in Obesity Market - Eli Lilly's Zepbound (tirzepatide) showed 25% weight loss in a late-stage study, outperforming CagriSema's 22.7%, raising skepticism about CagriSema's superiority in the REDEFINE 4 study [4] - Amgen's MariTide achieved 20% weight loss in 52 weeks, with potential for greater efficacy in longer studies and a once-monthly dosing advantage [9] - Lilly's tirzepatide injection products were removed from the FDA drug shortage list, giving Lilly a competitive edge over Novo Nordisk, whose semaglutide medicines remain on the list [14] Novo Nordisk's Market Performance and Studies - Novo Nordisk's shares lost 32.2% in the past three months, underperforming the industry's 17.4% decline [7] - Despite achieving the primary endpoint in the REDEFINE 1 study, Novo Nordisk's shares plunged 17.8% as CagriSema's 22.7% weight loss fell short of the company's 25% guidance [12] - Novo Nordisk is evaluating CagriSema in four phase III studies under the REDEFINE Program, with top-line data from the REDEFINE 2 study expected in the first half of 2025 [13] Mechanism of CagriSema - CagriSema combines cagrilintide 2.4 mg and Wegovy, promoting weight loss by suppressing hunger, enhancing fullness, and reducing calorie intake [6]