Novo Nordisk is seeking FDA approval for a 7.2 mg dose of Wegovy, nearly three times the current maximum dose.
The application is under expedited FDA review, with a decision expected within one to two months.
Shares of Novo Nordisk (NYSE: NVO) are gaining on Monday, up 3.5% as of 2:40 p.m. ET. The jump comes as the S&P 500 and the Nasdaq Composite gained 0.8% and 0.9%, respectively.
The Danish drugmaker submitted an application today seeking regulatory approval for a higher dose of its blockbuster weight-loss drug, Wegovy.
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Just days after a failed Alzheimer's trial sent Novo shares lower, today's regulatory filing revealed the company is seeking the Food and Drug Administration's (FDA) approval for a larger dose of Wegovy. The increased dose -- nearly three times the current maximum dose -- has shown promising results in trials lasting more than a year; participants lost an average of 20.7% of their body weight, compared to 15% in its current form.
Image source: Getty Images.
The application is part of an expedited review process at the FDA, and a decision is expected within one to two months.
The company's stock has been beaten down with a string of bad news and growing competition in the obesity and weight loss markets. I think it's been oversold. And while the road ahead will be bumpy, I think Novo Nordisk is a great long-term hold.
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Johnny Rice has no position in any of the stocks mentioned. The Motley Fool recommends Novo Nordisk. The Motley Fool has a disclosure policy.