Hims & Hers stock falls 14% after FDA changes semaglutide supply status (update)

seekingalpha
2024-10-31

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Shares of Hims & Hers (NYSE:HIMS) fell 14% Wednesday following news that Novo Nordisk’s (NVO) weight-loss drug Wegovy is no longer considered to be in short supply in the U.S.

Certain doses of the drug, along with its sibling drug Ozempic, have been on the FDA’s drug shortage list for months. Both drugs are based on the compound semaglutide. Hims & Hers (HIMS) has been marketing a compounded version of semaglutide during the shortage.

According to the FDA’s website on Wednesday, all doses of Wegovy and Ozempic are now available.

Earlier this month, the FDA removed rival drugs Mounjaro and Zepbound off its shortage list. The drugs, which are made by Eli Lilly (LLY), are based on the compound tirzepatide.

Meanwhile, makers and marketers of compounded versions of the drugs have come under pressure. In general, compounders are allowed by the FDA to make copies of certain drugs if they are considered to be in short supply, but not if they become more available.

On Oct. 7, The Outsourcing Facilities Association, a trade group representing compounding pharmacies and outsourcing facilities, filed a lawsuit against the FDA alleging that the agency had taken tizepatide off the list too soon and that the drug was still in short supply. The FDA has since said it is reviewing its decision.

Last week, Novo Nordisk (NVO) asked the FDA to have semaglutide placed on the Demonstrable Difficulties for Compounding List, arguing that compounded versions pose safety risks.

(Adds that compounding pharmacy trade group has sued FDA, updates stock move.)

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