Novo Nordisk Stock Rises 8% After FDA Vows Action, Legal Threat Over $49 Semaglutide
Novo Nordisk shares jumped 8% Friday after FDA pledged crackdown on unapproved copycat drugs and following its threat of legal action against Hims & Hers' $49 compounded semaglutide launch. The company forecasts fiscal 2026 adjusted sales growth of -5% to -13% at constant exchange rates, excluding revenue reversals from 340B provisions.
1. Stock Surges on Regulatory Backing
Novo Nordisk shares climbed 8% Friday as the U.S. Food and Drug Administration announced it will take swift action against companies marketing unapproved semaglutide knockoffs, reinforcing investor confidence in the company’s product integrity.
2. FDA’s Crackdown on Copycats
FDA Commissioner Marty Makary warned that non-approved drugs cannot be verified for quality, safety or effectiveness, signaling potential enforcement actions that could shut down competing compounded semaglutide offerings.
3. Fiscal 2026 Sales Outlook
The company projects adjusted sales growth for fiscal 2026 to decline between 5% and 13% at constant exchange rates, a forecast that excludes revenue reversals tied to 340B program provisions.
4. Legal Dispute with Hims & Hers
Novo Nordisk has accused Hims & Hers of illegally mass-marketing an unapproved $49 compounded semaglutide pill, vowing to initiate legal and regulatory measures to protect patient safety and its branded products.