Novo Nordisk Sues Hims & Hers Over Compounded Wegovy, Calls For Permanent Sales Ban: HIMS Stock Tanks

• Novo also stated that Hims & Hers is duping consumers and healthcare professionals as to the clinical benefits and safety of these unapproved drugs.
• Last week, the U.S. Food and Drug Administration warned of a crackdown last week on GLP-1 active pharmaceutical ingredients intended for use in non-FDA-approved compounded drugs.
• Subsequently, Hims & Hers announced that it would stop offering the $49 compounded version of Novo’s Wegovy.

Novo Nordisk A/S (NVO) on Monday stated that it has filed a lawsuit against Hims & Hers Health Inc. (HIMS), calling for a permanent ban on the company’s sales of unapproved, compounded drugs that infringe its patents.

Novo stated that it has filed the lawsuit to protect its intellectual property and the American public.

Novo shares were up more than 5% in Monday’s pre-market trade, while Hims & Hers shares were down more than 19% at the time of writing. Retail sentiment around the NVO stock trended in the ‘bullish’ territory on the platform.

Novo Accuses HIMS Of Duping Consumers

Novo stated that Hims & Hers is duping consumers and healthcare professionals as to the clinical benefits and safety of these unapproved drugs.

“Hims & Hers is mass marketing unapproved knock-off versions of Wegovy and Ozempic that evade the FDA’s gold standard review process – that’s dangerous and deceptive to patients, and undermines the scientific innovation and regulatory rigor in place to ensure these treatments are safe and effective,” said Novo Nordisk’s senior vice president, Group General Counsel, Global Legal, IP and Security, John F. Kuckelman.

The company also announced a share repurchase program on Monday of up to DKK 15 billion ($2.4 billion to be executed during a 12-month period beginning Feb. 4, 2026.

FDA Warns Of Crackdown On Compounded GLP-1 Drugs 

Last week, the U.S. Food and Drug Administration (FDA) warned of a crackdown last week on GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs.

“These actions are aimed to safeguard consumers from drugs for which the FDA cannot verify quality, safety, or efficacy.  We take seriously any potential violations of the Federal Food, Drug, and Cosmetic Act,” the agency said.

Subsequently, Hims & Hers announced that it would stop offering the $49 compounded version of Novo’s Wegovy.

Analysts Warn Of Sales Hit

The FDA crackdown has resulted in sharp price target cuts from analysts, according to TheFly.

Analysts at Citi warned that Hims & Hers’ launch of the compounded pill version of Wegovy is “risky and aggressive,” and that it brings more legal risk to the company.

The firm trimmed its price target for Hims & Hers to $16.5 from $30, while maintaining a ‘Sell’ rating. Citi analysts stated that the new price target factors in a 25% bear case probability of Hims & Hers losing all weight loss drug sales, a 60% base case probability of the company losing half of the sales, and a 15% bull case probability of limited GLP-1 downside from the legal challenges.

Analysts at BofA also lowered their price target for the HIMS stock to $21 from $26, while keeping an ‘Underperform’ rating. The firm noted that the FDA did not make a distinction between oral and injectable products in its crackdown warning.

This leads BofA analysts to believe that the FDA’s crackdown could extend beyond APIs for oral GLP-1 treatment and include APIs for injectable semaglutide as well. The firm believes this adds a new risk to Hims' injectable GLP-1 franchise.

How Stocktwits Users Reacted

Retail sentiment around Hims & Hers trended in the ‘extremely bullish’ territory at the time of writing.

One user pointed out that the company’s legal battle with Novo hasn’t even started yet.

NVO stock is down 7% year-to-date, while HIMS stock is down 29%.

$1 = DKK 6.30

Also See: PGY Stock Pops Pre-Earnings: Wall Street Bets On Pagaya’s AI-Powered Lending Model

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