TLDR
- Novo Nordisk stock climbed 8% after Hims & Hers cancelled its $49 weight-loss pill under FDA and legal pressure
- FDA’s crackdown on compounded GLP-1 drugs reduces competitive threats to Novo’s Wegovy and Ozempic
- Hims & Hers stock tumbled 14.8% in premarket trading after pulling the semaglutide-based product
- Novo’s stock had fallen 50% over the past year due to pricing pressure and competition
- The FDA’s move benefits both Novo Nordisk and rival Eli Lilly in the obesity drug market
Novo Nordisk shares jumped more than 8% Monday after Hims & Hers Health cancelled the launch of its $49 weight-loss pill. The telehealth firm pulled the product following legal threats from the Danish pharmaceutical company and FDA intervention.
The rally lifted Novo’s stock above pre-announcement levels from last week. Market watchers believe the FDA’s actions signal a wider crackdown on compounded GLP-1 medications that compete with branded treatments.
Hims & Hers rolled out the compounded pill Thursday using semaglutide, the active ingredient in Novo’s blockbuster drugs Wegovy and Ozempic. The announcement triggered immediate pushback from Novo Nordisk and regulatory officials.
On Saturday, Hims said it would stop offering the treatment after conducting discussions with stakeholders. The company’s shares fell 14.8% in premarket trading Monday.
FDA Moves to Restrict Compounded Weight-Loss Drugs
The FDA announced Friday it plans to limit GLP-1 ingredients in non-approved compounded medications. Telehealth firms and compounding pharmacies have marketed these products as cheaper alternatives to authorized therapies.
FDA Commissioner Marty Makary signaled the agency would increase scrutiny of unauthorized compounded GLP-1 drugs. The FDA raised concerns about quality, safety, and possible federal law violations.
Analysts at Sydbank and Jyske Bank said investors reacted positively to the FDA’s broader targeting of the unregulated compounding sector. “The FDA is not only declaring war on Hims & Hers’ Wegovy pill, but compounded GLP-1s in general,” said Sydbank analyst Soren Lontoft Hansen.
The regulatory action helps both Novo Nordisk and Eli Lilly. An Eli Lilly representative said the company supported the FDA’s decision.
Hims’ quick reversal represents an unusual win for Novo in its fight against copycat versions of its GLP-1 medications. The telehealth company did not respond to questions about whether it would continue selling compounded semaglutide injections.
Competition Remains Intense Despite Regulatory Win
Novo’s shares had already bounced back 5% Friday when the FDA first indicated its enforcement plans. Still, the company faces strong competition in the fast-changing GLP-1 marketplace.
Novo Nordisk’s market value has crashed nearly two-thirds from its June 2024 high. The stock has lost almost 50% over the past twelve months.
Shares plunged 17% in one day last week after Novo reported “unprecedented price pressure” in its full-year results. The company stunned investors by forecasting potential declines of up to 13% in both revenue and earnings for 2026.
The projection breaks years of double-digit growth. President Trump’s push to lower prescription drug costs has heated up competition in the high-margin obesity treatment space.
Eli Lilly has moved ahead in U.S. prescription volume and announced 2026 profit projections exceeding Wall Street estimates. Lilly’s oral GLP-1 medication orforglipron is expected to debut in April.
Compounding pharmacies continue selling injectable semaglutide products. Drugmakers are focusing more on direct-to-consumer channels and telehealth platforms to access millions of American patients.
All three companies—Hims, Novo Nordisk, and Eli Lilly—ran Super Bowl advertisements Sunday promoting their weight-loss offerings. Novo Nordisk stock remains down about 2% for the year.
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