Novo shares bounce back as FDA signals tougher stance on weight-loss drug knockoffs

Shares of Danish pharmaceutical group Novo Nordisk (NYSE:NVO) rallied on Friday, recovering some of the steep losses suffered earlier in the week after the U.S. Food and Drug Administration indicated it would step up action against the widespread promotion of unapproved copycat medicines.

Novo’s American depositary receipts surged more than 7% in premarket trading, while the stock gained over 5% in Copenhagen.

The rebound followed two bruising sessions, including an almost 8% slide on Thursday triggered by telehealth company Hims and Hers Health launching a low-cost $49 compounded alternative to Novo’s FDA-approved Wegovy weight-loss drug.

“FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products,” FDA Commissioner Marty Makary said on X, without naming specific firms.
“The FDA cannot verify the quality, safety or effectiveness of non-approved drugs,” he added.

The FDA’s comments came after Novo’s shares had plunged 17% in Copenhagen on Wednesday, when the company issued an early and downbeat outlook for 2026.

Novo warned that both sales and operating profit next year are expected to decline by between 5% and 13%, a far weaker projection than the market had been expecting.

“In 2026, Novo Nordisk will face pricing headwinds in an increasingly competitive market,” CEO Mike Doustdar said in a statement.
“However, we are very encouraged by the promising early uptake from the U.S. launch of Wegovy pill, and we remain confident in our ability to drive volume growth over the coming years,” he added.

The guidance marked a notable shift for a company that has delivered several years of double-digit revenue and profit growth since Wegovy was launched in 2021, sparking a boom in demand for obesity treatments and helping Novo become Europe’s most valuable listed company in 2024.

Novo said the weaker outlook reflects pressure from lower realized prices—especially in the U.S.—intensifying competition, and upcoming patent expiries for semaglutide, the active ingredient in Wegovy and Ozempic, in certain markets outside the United States.

Novo Nordisk stock price


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