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

Source 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."

Will AI create the world's first trillionaire? Our team just released a report on the one little-known company, called an "Indispensable Monopoly" providing the critical technology Nvidia and Intel both need. Continue »

Person looking intently at laptop.

Image source: Getty Images.

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.

Should you buy stock in Hims & Hers Health right now?

Before you buy stock in Hims & Hers Health, consider this:

The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Hims & Hers Health wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years.

Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $443,299!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,136,601!*

Now, it’s worth noting Stock Advisor’s total average return is 914% — a market-crushing outperformance compared to 195% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors.

See the 10 stocks »

*Stock Advisor returns as of February 9, 2026.

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.
placeholder
Bitcoin ETF Investors Face 8% Losses as $3 Billion Exits Market in Two WeeksUS spot Bitcoin ETF buyers are essentially the very investors expected to provide a stable, long-term bid for the pioneer crypto. However, data shows that these players are now sitting on mounting unr
Author  Beincrypto
Feb 03, Tue
US spot Bitcoin ETF buyers are essentially the very investors expected to provide a stable, long-term bid for the pioneer crypto. However, data shows that these players are now sitting on mounting unr
placeholder
Gold Prices Surge Amid Rising U.S.-Iran Tensions, Driving Safe-Haven Demand to New HeightsGold prices rebounded Wednesday, climbing 0.9% to $4,995.60 an ounce as geopolitical tensions between the U.S. and Iran heightened demand for safe-haven assets, despite recent market volatility.
Author  Mitrade
Feb 04, Wed
Gold prices rebounded Wednesday, climbing 0.9% to $4,995.60 an ounce as geopolitical tensions between the U.S. and Iran heightened demand for safe-haven assets, despite recent market volatility.
placeholder
Risks Rise for Bitcoin, Gold, and Silver as Goldman Sachs Warns $80 Billion in Stock SellingGlobal markets may be entering a new phase of volatility after Goldman Sachs warned that systematic funds could offload tens of billions of dollars in equities in the coming weeks.This wave of selling
Author  Beincrypto
21 hours ago
Global markets may be entering a new phase of volatility after Goldman Sachs warned that systematic funds could offload tens of billions of dollars in equities in the coming weeks.This wave of selling
placeholder
Arthur Hayes Attributes Bitcoin Crash to ETF-Linked Dealer HedgingArthur Hayes, the co-founder of BitMEX, suggested that institutional dealer hedging is exacerbating the recent downward pressure on Bitcoin prices.In a February 7 post on X, Hayes pointed to structure
Author  Beincrypto
21 hours ago
Arthur Hayes, the co-founder of BitMEX, suggested that institutional dealer hedging is exacerbating the recent downward pressure on Bitcoin prices.In a February 7 post on X, Hayes pointed to structure
placeholder
Fed to enter gradual money-printing phase, says Lyn AldenLyn Alden says the Federal Reserve is likely entering a gradual phase of money printing rather than aggressive stimulus.
Author  Cryptopolitan
21 hours ago
Lyn Alden says the Federal Reserve is likely entering a gradual phase of money printing rather than aggressive stimulus.
goTop
quote