Hims weight-loss pill push triggers FDA backlash

Hims & Hers Health’s attempt to launch a low-cost oral weight-loss pill has drawn swift regulatory and legal pushback, threatening the telehealth company’s next major growth strategy and intensifying scrutiny of drug compounders.

The company had been seeking new revenue drivers as its original sexual-health business matured, News.Az reports, citing Reuters.

But its plan to offer a compounded oral semaglutide pill, priced at $49, quickly triggered warnings from regulators and a lawsuit from Danish drugmaker Novo Nordisk.

U.S. FDA Commissioner Marty Makary described the proposed pill and similar offerings as “illegal copycats,” prompting Hims to retreat from the plan just two days after announcing it.

Novo Nordisk subsequently sued the company, alleging patent infringement related to its blockbuster GLP-1 weight-loss medicines.

Analysts said the oral GLP-1 product could have opened a significant new market for Hims, particularly among patients who prefer pills over injections. With that path now uncertain, investors are questioning where the company will find its next major growth engine.

“They probably looked at this as their next big driver of growth,” said Needham analyst Ryan McDonald, noting that other newer services such as testosterone therapy or cancer screenings are unlikely on their own to drive major subscription gains.

Hims declined to comment on the developments.

The company, led by CEO Andrew Dudum, has positioned itself as a lower-cost healthcare platform and recently boosted its public profile with a high-profile Super Bowl advertisement. It also donated $1 million to President Donald Trump’s inauguration — matching contributions from much larger pharmaceutical firms.

Much of Hims’ recent expansion has come from entering the injectable weight-loss market. The company reported less than $900 million in sales in 2023 but is expected by Wall Street to surpass $2.3 billion in 2025 revenue when results are released.

Even so, analysts expect growth to slow. After annual sales growth rates between 59% and 94% over the past four years, forecasts suggest expansion could cool to roughly 17% over the next two years.

Investor sentiment has already weakened: Hims shares are trading at less than a quarter of their mid-2025 peak and have fallen more than 45% since the weight-loss pill announcement.

Beyond regulatory risks, experts say the company faced significant technical challenges.

GLP-1 drugs are delicate peptide compounds that require specialized absorption technology to work effectively in pill form. Novo Nordisk’s oral semaglutide relies on patented delivery technology that Hims cannot use.

Hims had planned to rely on a complex liposomal delivery approach, but experts warned the method could be difficult to manufacture reliably at personalized doses and might raise safety concerns without prior FDA approval.

“It’s a tricky technology,” said INSEAD professor Prashant Yadav, noting that liposomal particles must be precisely sized to deliver medication properly.

Analysts expect pressure on compounded GLP-1 products to increase further as branded drug prices fall, insurance coverage improves and regulators tighten oversight.

“The problem with a platform based on gray-market products is that large drugmakers will ultimately win on scale and efficiency,” said BMO Capital Markets analyst Evan Seigerman.

With the obesity drug market projected to approach $100 billion annually by 2030, the setback underscores the high stakes, and growing regulatory risks, facing companies trying to compete in the booming GLP-1 space.

News.Az 

By Aysel Mammadzada