MRK · 10-Q · 2026Q2 · Full report

Regulatory Risk

Merck & Co., Inc. · 2026-08-07 · Importance 44 · Surprise 60

The FDA’s emergency-use framework for COVID-19 products is being terminated following the HHS Secretary’s June 29, 2026 determination that pandemic circumstances no longer justify emergency use. Lagevrio’s U.S. EUA is scheduled to terminate on June 29, 2027, and Merck does not anticipate FDA approval of its New Drug Application before that date. Merck is working with the FDA on a plan to dispose of U.S. Lagevrio inventory by June 29, 2027. The company also received a June 2026 inquiry from the U.S. House Select Committee on China regarding clinical trials and related activities in China.

Key facts

• The Company has sued the U.S. government regarding the IRA’s Drug Price Negotiation Program. source