MRK · News · 20260826N

Regulatory Risk

Merck & Co., Inc. · 2026-08-26 · Importance 18 · Surprise 24

The U.S. FDA extended its review of Capricor Therapeutics’ Duchenne muscular dystrophy cell therapy, indicating continued review-timing uncertainty for advanced therapies. The report also said President Trump nominated Heidi Overton as the next FDA commissioner on August 26, 2026. The prospective leadership change could affect U.S. vaccine policy, psychedelics, and new pain-medication approvals, although no specific Merck compliance cost or financial exposure was disclosed.

Key facts

• Keytruda's patent expiration is in 2028, which the company expects will impact the business. source