Regulation

Novo Nordisk Rebounds as FDA Vows Crackdown on Wegovy Copycats

Novo Nordisk B shares surged 5.29% after Hims & Hers halted its $49 compounded version of Wegovy, with the FDA pledging action against unauthorized copycats. The stock remains down roughly 20% over five sessions amid pricing uncertainty.

StockTi Editorial · · 2 min read · 0 views
Novo Nordisk Rebounds as FDA Vows Crackdown on Wegovy Copycats
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HIMS $23.02 -1.96% LLY $1,058.18 +3.66% NVO

Novo Nordisk Class B shares recovered some lost ground on Friday, closing at 295.50 Danish crowns, a 5.29% gain, following a steep two-day decline. The rebound came after digital health provider Hims & Hers announced it would stop selling a $49 compounded version of Novo's blockbuster weight-loss drug Wegovy.

Regulatory Pressure Mounts

The U.S. Food and Drug Administration has pledged to take swift action against the mass marketing of unauthorized copycat drugs. FDA Commissioner Marty Makary stated the agency plans to clamp down on firms pushing illegal compounded versions, particularly those containing GLP-1 ingredients used in unapproved products. The case has been referred to the Department of Justice for potential federal law violations.

Novo's stock had previously tumbled 7.88% on Thursday and plunged 17.17% on Wednesday, resulting in a five-session decline of approximately 20%. The pharmaceutical giant, along with Eli Lilly, has been investing heavily in Super Bowl advertising to capture cash-paying U.S. customers for their weight-loss medications.

Patent and Pricing Concerns

Analysts remain divided on what the incident reveals about Novo's patent protection for its pill technology. Morningstar's Karen Andersen highlighted Novo's SNAC absorption technology as crucial to Wegovy's effectiveness, suggesting compounded versions without it would be ineffective. However, Union Investment's Markus Manns called the situation "another level of uncertainty," raising questions about patent value for consumer-targeted drugs.

The pricing landscape continues to evolve rapidly. The Trump administration's TrumpRx.gov site now highlights discounted GLP-1 weight-loss drugs, with Reuters reporting prices as low as $149 monthly in some cases, down sharply from over $1,000. Despite these reductions, analysts note that even $200 monthly remains prohibitive for many potential patients.

As trading resumes in Copenhagen, investors will monitor for concrete FDA action on compounding ingredients, Justice Department movements, and whether weekend Super Bowl advertising stimulates demand or attracts more competitors to the cash-pay market.

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