Novo Nordisk (NYSE: NVO) shares surged in pre-market and after-hours trading after the company secured U.S. regulatory approval for the world’s first GLP-1 weight-loss pill, a milestone that materially reshapes the obesity drug market.

By press time, the stock was trading around $48.10, up about 7% in pre-market trading and having risen as much as 10% after hours, despite remaining nearly 50% lower year-to-date.

The approval gives the Danish drugmaker a decisive first-mover advantage over rivals, particularly Eli Lilly (NYSE: LLY), which is still awaiting clearance for its own oral GLP-1 treatment.

An effective pill alternative addresses one of the biggest barriers to adoption of injectable therapies, broadening access and potentially accelerating patient uptake in the U.S., the world’s most lucrative pharmaceutical market.

Novo plans to begin U.S. distribution in early January 2026, offering a starting dose of 1.5 milligrams through pharmacies and select telehealth providers at a monthly price of $149 for cash-paying patients.

Increasing pressure on drugmakers 

The pricing strategy aligns with intensifying political and regulatory pressure to rein in drug costs and could support wider penetration beyond insured patients, strengthening volume growth even at lower per-patient revenue.

Meanwhile, the regulatory win follows a volatile year for Novo Nordisk, marked by governance tensions, supply constraints, and scrutiny of its U.S. execution, all of which weighed on the stock.

Notably, approval of an oral GLP-1 reframes that narrative, signaling renewed momentum in Novo’s obesity franchise as it expands beyond injections.

With additional regulatory submissions underway in Europe and other regions, investors are increasingly focused on the pill’s global rollout potential and its ability to reaccelerate growth after a sharp share-price correction.

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