New York, Jan 15, 2026, 13:56 EST — Regular session
- Merck shares slipped in afternoon trading, pulling back after a recent surge pushed the stock close to its highs
- A Reuters report revealed the FDA is delaying certain deadlines in its new “voucher” fast-track program
- Investors are eyeing Merck’s Feb. 3 earnings for updates on its pipeline and 2026 outlook
Shares of Merck & Co slipped 0.2% to $110.75 on Thursday, fluctuating within a range of $108.48 to $111.06 during the day.
The shift arrives as investors adjust their outlook on the U.S. Food and Drug Administration’s new fast-track review process. Initially marketed as a shortcut, the effort is already encountering signs of pushback.
The Commissioner’s National Priority Voucher program aims to slash review times to just one or two months for a select group of medicines. Merck has already landed vouchers for its experimental cholesterol drug enlicitide and a cancer treatment called sacituzumab tirumotecan, or sac-TMT. (Reuters)
Internal documents reviewed by Reuters reveal the FDA has postponed its evaluations of Sanofi’s Tzield and Disc Medicine’s bitopertin, following safety and efficacy concerns—including a reported patient death linked to one case. Two additional review deadlines have slipped as well, including the April 10 target for Eli Lilly’s weight-loss drug. “Hold on, we’re not actually sure this product should be allowed on the market,” said Holly Fernandez Lynch, a health policy professor at the University of Pennsylvania. Disc CEO John Quisel responded, “We feel very good about our data package and its potential.” (Reuters)
Healthcare stocks dragged the sector down, with the Health Care Select Sector SPDR Fund slipping roughly 0.5%. Eli Lilly dropped 3.6%. Johnson & Johnson and Pfizer edged up slightly, but AbbVie and Bristol Myers Squibb fell.
Merck jumped 2.5% Wednesday, closing at $111.01, edging out several major drugmakers as the broader market slipped. (MarketWatch)
The FDA program is still fresh, and even minor delays can hit drugmakers hard when investors expect faster approvals and quicker revenue. On top of that, Merck is grappling with a longer-term issue: diversifying beyond Keytruda. Its best-selling cancer drug’s intravenous patent runs out in 2028, cutting into exclusivity. (Nasdaq)
Traders are on alert for any new FDA updates on the voucher program’s timeline and whether the agency plans to tighten standards beyond what the initial announcements suggested. Merck’s next major event is its Q4 earnings report and call scheduled for Feb. 3. (Merck)
