Shares of Hims & Hers Health (NYSE:HIMS) dropped 10% on Friday after the U.S. Food and Drug Administration warned it would move against companies promoting unapproved versions of prescription drugs, a development that rattled investors just a day after the telehealth group launched a cheaper alternative to a Novo Nordisk (NYSE:NVO) weight-loss treatment.
The decline followed comments from FDA Commissioner Dr. Marty Makary, who wrote on social media platform X that the agency “will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.” Although Hims & Hers was not named directly, the statement came shortly after the company announced it would offer a compounded version of semaglutide priced at $49 for the first month and $99 thereafter under a five-month plan.
In contrast, Novo Nordisk shares jumped 7% on Friday, rebounding from losses the previous session that were triggered when Hims & Hers revealed its lower-cost alternative to Novo’s Wegovy.
Novo Nordisk pushed back strongly against the move, describing it as “illegal mass compounding that poses a significant risk to patient safety” and saying it would “take legal and regulatory action” against the company. The Danish drugmaker also stressed that only its FDA-approved Wegovy pill incorporates the proprietary SNAC technology required for oral absorption of semaglutide.
Reinforcing those concerns, the FDA commissioner cautioned that the agency “cannot verify the quality, safety, or effectiveness of non-approved drugs,” casting doubt over Hims & Hers’ efforts to broaden access to weight-loss medications at prices comparable to a monthly streaming subscription.