Hims & Hers Collapses After FDA Vows to Restrict Copycat GLP-1 Pill. Is the Stock Toast?

Source The Motley Fool

Key Points

  • On Friday, the U.S. Food and Drug Administration said it would take "decisive steps" to restrict GLP-1 ingredients in compounded drugs not approved by the agency.

  • Last week, Hims & Hers announced plans to offer a copycat GLP-1 pill at a lower price point than Novo Nordisk, which is also suing Hims & Hers.

  • Recent growth at Hims & Hers has been driven by demand for GLP-1 drugs.

  • 10 stocks we like better than Hims & Hers Health ›

The telehealth company Hims & Hers (NYSE: HIMS), which provides consultations and prescriptions, saw its stock crater by nearly 16% on Feb. 9 after deciding not to move forward with plans to offer a copycat GLP-1 pill.

This decision was made after U.S. Food and Drug Administration last Friday announced its "intent to take decisive steps to restrict GLP-1 active pharmaceutical ingredients (APIs) intended for use in non-FDA-approved compounded drugs that are being mass-marketed by companies -- including Hims & Hers and other compounding pharmacies -- as similar alternatives to FDA-approved drugs."

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Hims & Hers has previously sold an injectable weight-loss treatment that used compounded semaglutide, the active ingredient in Novo Nordisk's Ozempic and Wegovy, which are used to help suppress appetite and aid weight loss. Novo Nordisk then created a version of Wegovy in pill form that would cost $149 per month.

Hims & Hers last week announced a copycat version of the Wegovy pill that would cost $49 for the first month and $99 per month after on a five-month plan. That sent the stock surging last week, but shortly after the announcement, Novo Nordisk announced plans to sue Hims & Hers for patent infringement, which led the stock to give up those gains.

Hims & Hers' stock is now down over 58% in the past year. Is the company toast?

GLP-1 is a big part of Hims & Hers' business

Through the first nine months of 2025, Hims & Hers grew revenue by 74% year over year, driven largely by demand for the company's alternative weight-loss treatments.

The stock shot higher on several occasions in 2025 but has since pulled back, likely due to concerns about the sustainability of the company's revenue from GLP-1 drugs.

Hims & Hers has called Novo Nordisk's lawsuit a "blatant attack" on "millions of Americans who rely on compounded medications for access to ‌personalized care... Once again, big pharma is weaponizing the U.S. judicial system to ​limit consumer choice."

However, the FDA seems serious about cracking down on copycat drugs, and the agency's specific naming of Hims & Hers is not a good sign.

Given the intense demand for GLP-1 drugs and increasing competition, prices for these drugs are likely to come down over time, which would make the business tougher, even if Hims & Hers manages to escape current regulatory and legal issues. Furthermore, the telehealth market, which was a darling during the pandemic, has lost some of its appeal and faces significant competition.

I don't necessarily know if Hims & Hers is toast, but I would avoid the stock right now to let the legal and regulatory concerns play out.

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Bram Berkowitz has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Hims & Hers Health. The Motley Fool recommends Novo Nordisk. The Motley Fool has a disclosure policy.

Disclaimer: For information purposes only. Past performance is not indicative of future results.
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