Novo Nordisk (NVO) Up 3% as Haemophilia Drug Meets Study Goals

Core Insights - Novo Nordisk (NVO) achieved co-primary endpoints in a late-stage study for Mim8, demonstrating its efficacy and safety in reducing bleeding episodes in haemophilia A patients aged 12 years or older [1][5] - The phase IIIa FRONTIER 2 study showed a statistically significant reduction in treated bleeding episodes with both once-weekly and once-monthly Mim8 compared to no prophylaxis and prior coagulation factor prophylaxis treatments [1][4] Study Results - The study observed superior reductions of 97% and 99% in treated bleeds for once-weekly and once-monthly Mim8, respectively, compared to no prophylaxis [4] - Zero treated bleeds were reported in 86% of patients receiving once-weekly Mim8 and 95% of those on once-monthly dosing [4] - In patients with prior coagulation factor prophylaxis, reductions of 48% and 43% in treated bleeds were noted for once-weekly and once-monthly Mim8, respectively [4] Safety Profile - Mim8 was well tolerated in the FRONTIER 2 study, with no deaths or thromboembolic events reported [5] - The safety profile of Mim8 was consistent with previous studies, indicating its potential for safe use in the target patient population [5] Future Plans - Novo Nordisk plans to present detailed data from the phase III FRONTIER program at medical conferences in 2024 and 2025 [2] - The company is preparing to discuss the study results with regulatory authorities and aims to submit Mim8 for regulatory approval by the end of 2024 [5] Market Performance - Following the positive study results, Novo Nordisk's shares increased by 3.1% on May 14, with a year-to-date gain of 28%, outperforming the industry growth of 13.4% [2]