Today: 30 June 2026
Merck stock price slips as FDA fast-track doubts surface before MRK earnings

Merck stock price slips as FDA fast-track doubts surface before MRK earnings

NEW YORK, Jan 16, 2026, 21:08 EST — Market closed.

Shares of Merck & Co (MRK.N) dipped 1.9% Friday, closing at $108.83 following a range of $108.49 to $111.19. The stock kicked off the session at $110.63 with roughly 14.9 million shares traded.

The drop came as investors digested a Reuters report revealing some drugmakers’ unease over the FDA Commissioner’s National Priority Voucher Program — a fast-track approval process launched in June that cuts review times to one or two months for select drugs. At the J.P. Morgan Healthcare Conference, executives and advisers warned the accelerated timeline might compromise safety checks and spur legal battles if patients suffer serious side effects. One executive said their company wouldn’t pursue a voucher, doubting the program’s longevity. Eli Lilly’s research head Dan Skovronsky, whose weight-loss drug is among those eligible along with offerings from Merck and others, said, “We welcome anything that gets medicines to patients faster.” Meanwhile, McKinsey’s Greg Graves noted, “If standards hold, it’ll be hard to unmake history.” Reuters

Merck investors know uncertainty hits launch timelines and peak-sales forecasts hard. A quicker green light can boost near-term revenue, while delays at the agency can just as easily push earnings further down the road.

Internal documents reviewed by Reuters reveal FDA reviewers have delayed some drug evaluations within the program following concerns over safety and effectiveness. This includes adverse event reports and a patient death linked to Sanofi’s Tzield, though Sanofi stated no causal link has been proven. Holly Fernandez Lynch, a health policy professor at the University of Pennsylvania, called the delays “reassuring,” highlighting the agency’s caution with “Hold on, we’re not actually sure.” The papers set a decision deadline for Eli Lilly’s weight-loss pill at April 10, 2026, and note that two Merck drugs are among the 18 products chosen so far, with only one drug approved under the program to date. Reuters

The broader market offered little support. The Dow dropped 0.17%, the S&P 500 slipped 0.06%, and the Nasdaq edged down 0.06% during a volatile session ahead of the long weekend. The S&P 500 healthcare sector led the losses, falling 0.8%, according to a Reuters market wrap, with Wall Street set to be closed Monday for the Martin Luther King Jr. holiday.

The extra day off extends the spotlight on FDA headlines longer than normal. Traders are hunting for clues about voucher distribution and whether the agency adopts a tougher stance on drug labels, which detail critical risks for doctors and patients.

Merck, aiming to expand its lineup beyond Keytruda, told investors this week it forecasts $70 billion in revenue from new growth areas by the mid-2030s.

Yet the fast-track debate isn’t one-sided: if the voucher program sparks legal challenges or drags out delays, the pipeline’s “pull-forward” appeal dims. On the flip side, if rapid approval leads to serious side effects, drugmakers might get hit with tougher lawsuits and extra warnings.

Merck is set to report its latest quarterly results on Feb. 3, with an earnings call scheduled for 9 a.m. ET. Investors will be watching closely for updated guidance and details on launch timing, which could shape MRK’s next trading moves when the market opens next week.

Khadija Saeed is a financial markets reporter at TS2.tech, specializing in stocks, technology and emerging industries. She studied economics and finance at the London School of Economics and previously worked in market research before moving into financial journalism. Her coverage focuses on the companies, innovations and economic trends influencing global investors.

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