New York, January 16, 2026, 15:04 EST — Regular session
- Merck shares dropped roughly 1.2% in afternoon trading, lagging behind the broader market
- Investors are weighing fresh scrutiny over the FDA’s ultra-fast “voucher” review program, which features drugs from Merck
- Attention turns to Merck’s Feb. 3 earnings, with investors eyeing updated guidance and pipeline milestones
Merck & Co shares (MRK.N) dropped roughly 1.2% to $109.65 on Friday, erasing earlier gains and settling near the session lows. The stock swung between $108.49 and $111.19 during the day, with around 7.6 million shares changing hands by the afternoon.
The decline followed weakness in large-cap healthcare, despite the broader market staying flat. The Health Care Select Sector SPDR Fund slipped roughly 0.4%, with the SPDR S&P 500 ETF barely budging. Bristol Myers Squibb and Regeneron fell, while Eli Lilly edged up.
Investors are digesting regulatory risks after a Reuters report revealed that some drugmakers worry about legal exposure tied to the FDA commissioner’s National Priority Voucher Program, which aims for one- to two-month decisions on certain drugs. Richard Pazdur, a former FDA official, noted that some companies “are not going ahead with it.” McKinsey senior partner Greg Graves added that if the reviews remain strict, “it’ll be hard to unmake history.” Reuters
The debate intensified late Thursday after Reuters revealed the FDA had postponed reviews of two drugs in the program amid safety and efficacy worries, including a reported patient death, according to internal documents. Holly Fernandez Lynch, a professor at the University of Pennsylvania, described the delays as “a very good sign,” suggesting reviewers are ready to hit pause if a product’s market readiness is in doubt. Reuters
Merck is working on two experimental drugs linked to the voucher program: its cholesterol medication enlicitide decanoate and the cancer treatment sacituzumab tirumotecan, or sac‑TMT, Reuters has reported. The FDA anticipates Merck will file for approval in April and again in 2026. The company is pushing to expand its pipeline ahead of biosimilar competition expected later this decade for Keytruda, its bestselling cancer drug that generates nearly $30 billion annually. Reuters
All eyes now shift to earnings. Merck plans to release its fourth-quarter and full-year 2025 results on Feb. 3, followed by a conference call at 9 a.m. ET. Merck.com
Investors will be tuning in for clues on how management views the future beyond Keytruda. They’ll watch to see if faster regulatory routes are seen as a boost, a bureaucratic burden, or a trigger for increased scrutiny instead of easing the process.
The downside is clear. If the voucher program drags or triggers lawsuits forcing companies into more cautious labeling and disclosures, late-stage launch schedules might slip, undermining the “pipeline fixes everything” story.
Merck still faces the usual challenges of drug development: trial results might fall short, regulators could demand additional data, and rivals can snatch away opportunities that seemed promising just a quarter ago.
Traders are now focused on Feb. 3 — not only for the numbers but also for any solid details on filing plans for 2026, the speed of upcoming launches, and Merck’s outlook on how Washington’s fast-track experiment might affect its pipeline candidates.
