Novo Nordisk has formally threatened legal and regulatory action against Hims & Hers following the launch of a compounded semaglutide pill priced at an introductory $49 for the first month. In its statement, the Danish pharma giant labeled the Hims & Hers product an "unapproved, inauthentic, and untested knockoff," warning that it violates mass‐compounding regulations and poses significant patient safety risks. Novo Nordisk underscored that only its FDA-approved Wegovy oral formulation—protected by SNAC technology—meets established standards for consistent semaglutide absorption and purity.

Shares of Novo Nordisk have come under pressure, slipping nearly 6% following the legal threat and a softer fiscal 2026 outlook. Management now forecasts a 5% to 13% decline in sales and operating profit for the year, driven by pricing pressures in the U.S., patent expirations, and intensifying competition in the GLP-1 category. The company’s obesity franchise, which grew 31% in 2025, may see margins compressed due to the higher cost of manufacturing and lower list prices on oral semaglutide.

In response to competitive and regulatory headwinds, Novo Nordisk is doubling down on its R&D pipeline and expanding manufacturing capacity to safeguard market share. The company has maintained full supply across all Wegovy doses and plans leadership changes in U.S. operations to navigate pricing negotiations. For long-term investors, the current valuation—trading near a 13.8 forward P/E—may present an attractive entry point ahead of anticipated volume‐driven recovery post-2026, assuming the company successfully defends its intellectual property and regulatory standing.