Novo Nordisk rises as Hims & Hers backs down on oral GLP-1

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Pedro Farto

Novo Nordisk's battered stock enjoyed a moment of reprieve after Hims & Hers abandoned plans to launch a compounded version of the just-launched Wegovy pill.

Shares in the Danish pharma group were up more than 8% at the time of writing this morning as Hims & Hers retreated from the launch of an oral semaglutide product at the knockdown starting price of $49 per month.

The climbdown by telehealth company Hims & Hers seems to have been catalysed by some combative rhetoric coming out of the FDA, which pledged "decisive steps" to restrict compounding of GLP-1 agonist medicines that are being "mass-marketed by companies."

Under US regulations, compounders can only provide in-patent medicines that are in short supply – which no longer applies to semaglutide – or in niche applications to provide personalised formulations not available from the original manufacturer.

With the shortages route now closed off, some compounders have attempted to get around regulations by launching 'microdose' or 'bespoke' formulations of GLP-1 drugs, although, until now that applied only to injectable formulations.

Novo Nordisk only launched oral Wegovy in January and is banking on the new formulation making strong sales as it faces pressure on its current injectable formulation of Wegovy, which saw sales figures in the US go into reverse for the first time in the fourth quarter of 2025.

Wegovy is the first GLP-1 to be available in the US for weight loss in an oral formulation, and Novo Nordisk has already reported strong take-up, with 170,000 people taking the drug as of last week, many of whom appear to be new to GLP-1 agonist therapy for weight loss as they are using the starting dose.

In its statement, the FDA said that it will take steps to "combat misleading Direct-To-Consumer advertising and marketing" of compounded medicines, emphasising that compounders "cannot claim that non-FDA-approved compounded products are generic versions or the same as drugs approved by FDA."

It also threatened to restrict access to sources of active ingredients used to make compounded medicines, and to refer the company for investigation by the Department of Justice.

Shares in Hims & Hers fell nearly 14% in after-hours trading. In a terse statement on social media, the company said that after "constructive conversations with stakeholders across the industry," it had "decided to stop offering access to this treatment."

The FDA's toughened stance on compounding will be good news for other drug developers, including Eli Lilly, which is hoping to bring its own oral GLP-1 product, orforglipron, to the US market following an FDA approval decision expected in the second quarter.

Photo by Pedro Farto on Unsplash