Eli Lilly stock slides premarket after FDA sets April 10 target for weight-loss pill decision, GLP-1 lawsuit filed

Eli Lilly stock slides premarket after FDA sets April 10 target for weight-loss pill decision, GLP-1 lawsuit filed

New York, January 16, 2026, 05:24 EST — Premarket

  • Shares of Eli Lilly slipped roughly 3.8% in premarket action, hitting $1,033.
  • FDA documents obtained by Reuters pointed to an April 10 target date for a decision on Lilly’s weight-loss pill, accelerated under a fast-track voucher program.
  • A compounding pharmacy has filed a lawsuit against Lilly and Novo Nordisk in Texas, accusing them of imposing restrictions on more affordable compounded GLP-1 medications.

Eli Lilly and Co shares slipped 3.8% in premarket trading Friday, following a wave of regulatory and legal news around its obesity drugs late last week. The stock last traded at $1,032.97.

These shifts are crucial since Lilly’s valuation now hinges on the outlook for its upcoming obesity drugs and how long demand lasts for its existing blockbusters. Delays or new legal battles over access could quickly alter investor growth forecasts.

Traders are recalibrating after a week packed with healthcare news, shifting focus to the next moves from regulators and upcoming management comments for investors.

Late Thursday, Reuters revealed internal U.S. Food and Drug Administration documents indicating Lilly’s weight-loss pill now faces a decision date of April 10, 2026, under the FDA’s Commissioner’s National Priority Voucher Program. This fast-track system was designed to cut review times to one or two months. A Lilly spokesperson said approval could come in the second quarter, per current FDA guidance. Health policy professor Holly Fernandez Lynch at the University of Pennsylvania called the delays “a very good sign,” suggesting regulators are willing to halt progress when doubts about a product’s safety or efficacy arise. (Reuters)

Strive Specialties, a compounding pharmacy, separately filed suit against Lilly and Novo Nordisk in Texas federal court. The complaint alleges the companies abused their stronghold on the GLP-1 market by blocking cheaper, compounded alternatives. Lilly pushed back, calling Strive’s claims “wrong, on both the facts and law.” Novo Nordisk dismissed the allegations as baseless and vowed to defend itself. (Reuters)

GLP-1 drugs treat diabetes and aid weight loss. Compounding pharmacies sometimes create tailored versions of these medicines. As demand for branded GLP-1 injections soared, so did the controversy over compounded alternatives.

Shares of Novo Nordisk, listed in the U.S., slipped roughly 3.0% in premarket action.

Still, this market move might not last when regular trading kicks off. FDA deadlines can shift, and lawsuits over drug access often drag on for months before it’s clear if they’ll alter business strategies or just rack up legal expenses.

Traders are now turning their attention to potential new FDA guidance on the voucher program and the agency’s stance on the April 10 deadline. Investors will also be keenly awaiting Lilly’s earnings call on Feb. 4 for updates on demand, supply, and pricing trends in its diabetes and obesity divisions. (Lilly)

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