Hims & Hers falls as FDA to target “illegal copycat drugs”

Hims & Hers Health (HIMS) fell ~8% in the premarket on Friday after FDA Commissioner Marty Makary said that his agency will take swift action against “companies mass-marketing illegal copycat drugs.”

The telehealth platform is well known for marketing the compounded versions of Novo Nordisk’s (NV) weight-loss therapy semaglutide at a steep discount to the branded product.

Makary’s remarks came after Hims & Hers (HIMS) rolled out a low-cost version of the Danish drugmaker’s newly launched oral obesity therapy, the Wegovy pill, on Thursday, indicating a roughly $100 discount to the brand-name version.

Shares of Novo (NVO) and its weight loss rival Eli Lilly (LLY) fell in reaction to the announcement, while HIMS shares climbed.

However, HIMS closed ~4% lower after Novo (NVO) said it would take legal and regulatory measures against what it called “illegal mass compounding and deceptive advertising by Hims & Hers.”

“FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products,” Makary wrote in an X post on Thursday. “The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs,” he added.

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