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Shares of Novo Nordisk (NVO) jumped 10% after-hours on Monday after the U.S. Food and Drug Administration approved its Wegovy pill to reduce body weight and maintain weight reduction for a longer term.
The Wegovy pill is now the first FDA-approved oral GLP-1 class drug for weight management and marks a crucial step forward for the company in its ongoing efforts to protect market share from rival Eli Lilly whose injectable GLP-1 drug Zepbound is fast eroding injectable Wegovy’s market dominance.
The Danish drugmaker expects to launch the pill in the U.S. in January. Novo already sells oral semaglutide as Rybelsus for Type 2 diabetes. Semaglutide is the active ingredient of Wegovy as well.
Novo’s rival Lilly, meanwhile, is looking forward to getting its oral obesity drug Orforglipron approved by early 2026. The drug helped people lose an average of 12.4% of body weight at its highest dose at 72 weeks in a study.
Provided Lilly’s drug indeed gets approval by early 2026, Novo will get a few months head start against its rival. LLY's shares fell 1.5% after hours on Monday.
The FDA approval for Wegovy pill is based on results from a trial program where oral semaglutide 25 mg taken once daily demonstrated 16.6% mean weight loss, similar to that of injectable Wegovy 2.4 mg, at 64 weeks.
“As the first oral GLP-1 treatment for people living with overweight or obesity, the Wegovy pill provides patients with a new, convenient treatment option that can help patients start or continue their weight loss journey. No other current oral GLP-1 treatment can match the weight loss delivered by the Wegovy pill, and we are very excited for what this will mean for patients in the US,” said CEO Mike Doustdar. The company is also looking forward to approval of the drug from other regulatory authorities including the European Medicines Agency.
Novo named Mike Doustdar as CEO of the company in August after Lars Fruergaard Jørgensen stepped down in May. Jørgensen decided to step down as per a mutual agreement with the Novo Nordisk board. The board stated that the change is being made in light of Novo Nordisk's recent market challenges and the company’s declining share price since mid-2024.
Novo also recently attempted to boost its pipeline with the acquisition of obesity drug maker Metsera but lost out to Pfizer.
On Stocktwits, retail sentiment around NVO jumped from ‘bearish’ to ‘bullish’ territory over the past 24 hours, while message volume rose from ‘normal’ to ‘high’ levels.
A Stocktwits user sees the stock rising as much as 20% on the next trading day.
Another user sees the stock nearly doubling from current levels to touch $100 next year.
NVO stock has lost 44% this year and by 46% over the past 12 months.
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