Shares of Hims & Hers tumble 26% after FDA says semaglutide is no longer in shortage
In this article
Shares of Hims & Hers Health
closed down around 26% on Friday after the U.S. Food and Drug Administration announced that the shortage of semaglutide injection products has been resolved.
Semaglutide is the active ingredient in Novo Nordisk’s blockbuster weight loss drug Wegovy and diabetes treatment Ozempic. Those medications are part of a class of drugs called GLP-1s, and demand for the treatments has exploded in recent years. As a result, digital health companies such as Hims & Hers have been prescribing compounded semaglutide as an alternative for patients who are navigating volatile supply hurdles and insurance obstacles.
Compounded drugs are custom-made alternatives to brand-name drugs designed to meet a specific patient’s needs, and compounders are allowed to produce them when brand-name treatments are in shortage. The FDA doesn’t review the safety and efficacy of compounded products.
Hims & Hers began offering compounded semaglutide to patients in May, and it owns compounding pharmacies that produce the medications.
Compounded medications are typically much cheaper than their branded counterparts. Hims & Hers sells compounded semaglutide for less than $200 per month, while Ozempic and Wegovy both cost around $1,000 per month without insurance.
The FDA said Friday that it will start taking action against compounders for violations in the next 60 to 90 days, depending on the type of facility, in order to “avoid unnecessary disruption to patient treatment.”
“Now that the FDA has determined the drug shortage for semaglutide has been resolved, we will continue to offer access to personalized treatments as allowed by law to meet patient needs,” Hims & Hers CEO Andrew Dudum posted Friday on X. “We’re also closely monitoring potential future shortages, as Novo Nordisk stated two weeks ago that it would continue to have ‘capacity limitations’ and ‘expected continued periodic supply constraints and related drug shortage notifications.’”
Him & Hers’ weight loss offerings have been a massive hit with investors. Shares of the company climbed more than 200% last year, and the stock is already up more than 100% this year despite Friday’s move.
Even before it added compounded GLP-1s to its portfolio, the company said in its 2023 fourth-quarter earnings call that it expects its weight loss program to bring in more than $100 million in revenue by the end of 2025.
Despite the turbulent regulatory landscape, Hims & Hers has showed no signs of slowing down.
On Friday, the company announced it has acquired a U.S.-based peptide facility that will “further verticalize the company’s long-term ability to deliver personalized medications.” Hims & Hers will explore advances across metabolic optimization, recovery science, biological resistances, cognitive performance and preventative health through the acquisition, the company said.
That move comes just days after Hims & Hers also bought Trybe Labs, the New Jersey-based at-home lab testing facility. Trybe Labs will allow Hims & Hers to perform at-home blood draws and more comprehensive pretreatment testing.
Hims & Hers did not disclose the terms of either deal.
WATCH: Hims & Hers Super Bowl ad sparks controversy
Got a confidential news tip? We want to hear from you.
Sign up for free newsletters and get more CNBC delivered to your inbox
Get this delivered to your inbox, and more info about our products and services.
© 2025 CNBC LLC. All Rights Reserved.
A Division of NBCUniversal
Data is a real-time snapshot *Data is delayed at least 15 minutes. Global Business and Financial News, Stock Quotes, and Market Data and Analysis.
Data also provided by
Read more CNBC tech news
News Tips
CNBC Newsletters
Advertise With Us
Treating Obesity
The FDA has removed semaglutide from its drug shortage list after the agency determined the current supply of the drug can meet present and future demand, Novo Nordisk and the FDA announced.
On Feb. 21, the FDA updated its drug shortage list and labeled the shortage of all doses of injectable semaglutide (Ozempic/Wegovy) as being resolved. The update was confirmed in a press release by Novo Nordisk, which stated the company continues to ship all doses of semaglutide regularly to wholesalers following investments to increase its manufacturing capacity.
“We are pleased the FDA has declared that supply of the only real, FDA-approved semaglutide medicines is resolved, affirming that Novo Nordisk is meeting or exceeding current and projected nationwide demand,” Dave Moore, executive vice president of U.S. operations and global business development and president of Novo Nordisk, said in the release. “No one should have to compromise their health due to misinformation and reach for fake or illegitimate knock-off drugs that pose significant safety risks to patients. Patient safety remains our top priority and, in line with our purpose to improve lives and health, we continue to partner, educate, and advocate for expanded, affordable access to our medicines for those who need and rely on them.”
As Healio previously reported, semaglutide was added to the FDA shortage list in early 2022. Its placement on the drug shortage list allowed compounding pharmacies to manufacture semaglutide, as the FDA did not consider the drug to be “commercially available” in the U.S.
The FDA announced it will allow companies to continue dispensing compounded semaglutide for up to 90 more days. State-licensed pharmacies and physicians compounded under section 503A of the Federal Food, Drug and Cosmetic Act can continue compounded and distributing semaglutide until April 22, and outsourcing facilities under section 503B of the law are permitted to dispense compounded semaglutide until May 22. The agency stated the deadlines were set “to avoid unnecessary disruption to patient treatment.”
Semaglutide’s removal from the drug shortage list comes about 2 months after the FDA also confirmed that the shortage of tirzepatide (Mounjaro/Zepbound, Eli Lilly), another incretin-based drug for treating type 2 diabetes and obesity, was resolved. As part of that announcement, the FDA stated it would continue to allow compounded forms of the drug to be manufactured or distributed by state-licensed pharmacies through Feb. 18 and by outsourcing facilities through March 19.
During the shortage, the FDA has issued multiple warnings about using off-brand semaglutide. In December 2023, the FDA announced counterfeit forms of semaglutide were circulating through the U.S. drug supply chain and asked consumers to check lot numbers to make sure they were using an authentic form of the drug. In February 2024, the agency sent warning letters to two companies for offering unapproved and misbranded forms of semaglutide and tirzepatide on their websites. In July 2024, the FDA warned patients about potential adverse events linked to some compounded forms of semaglutide due to dosing errors.
The removal of semaglutide from the drug shortage list comes as public officials raise concerns about counterfeit and illegal forms of diabetes and obesity medications entering the U.S. On Feb. 19, the National Association of Attorneys General sent a letter to acting FDA commissioner Sara Brenner, MD, MPH, asking the agency to take steps to stop “bad actors” from profiting off the sale of counterfeit incretin-based drugs. The letter cited reports of counterfeit GLP-1s entering the U.S. from foreign countries, active ingredients of the drugs being sold illegally to consumers and compounding pharmacies that may be participating illegally in the market. The letter was signed attorneys general from 38 states and U.S. territories.
“Demand for the medications Mounjaro, Zepbound, Ozempic and Wegovy has skyrocketed, but supply shortages and high costs have created opportunities for wrongdoers to cash in and endanger consumers,” the organization stated in its letter. “The FDA has the expertise and the resources to stop this conduct and better protect consumers.”
Collapse
Press Release
Read more about
Play on Healio
Follow Healio
About
Account Information
Contact Us
Legal
Sign Up for Email
Get the latest news and education delivered to your inbox
