New York, Jan 15, 2026, 12:06 (EST) — Regular session
- Lilly shares dropped following a Reuters report that the FDA pushed back its decision on the company’s experimental weight-loss pill to April 10
- A compounding pharmacy has filed a lawsuit against Lilly and Novo Nordisk, accusing them of anticompetitive behavior related to GLP-1 drugs
- Investors are eyeing the Feb. 4 results for any news on the pill’s timeline, demand, and potential legal risks
Eli Lilly and Company shares dropped 4.7% to $1,022.50 on Thursday after Reuters reported that internal documents revealed U.S. regulators delayed a decision on the drugmaker’s weight-loss pill until April 10. A Lilly spokesperson said approval could still come in the second quarter, aligning with current FDA guidance. Holly Fernandez Lynch, a health-policy professor at the University of Pennsylvania, commented on the FDA’s cautious stance, saying, “Hold on, we’re not actually sure this product should be allowed on the market,” highlighting the agency’s readiness to slow fast-tracked reviews. (Reuters)
The timing is crucial since Lilly’s obesity franchise drives the stock’s momentum, with traders betting on a pill as the next chapter. Just a few weeks can flip the race against competitors and alter forecasts on how fast payers and doctors switch from injections to tablets.
GLP-1, or glucagon-like peptide-1, refers to a group of diabetes and weight-loss drugs that replicate a gut hormone to suppress appetite. While Lilly’s injectable GLP-1 therapies have boosted demand, introducing a pill could expand the market by eliminating needles and the need for cold-chain storage.
J.P. Morgan Healthcare Conference: CEO David Ricks described the FDA review of Lilly’s obesity drug orforglipron as a “rapid review” that’s “moving at pace,” with a decision anticipated in Q2. This swift timetable has already tightened expectations into the stock, explaining why investors react sharply when timelines shift. (BioPharma Dive)
Shares slid broadly in the sector. Novo Nordisk’s U.S.-listed stock dropped 3.6%, while the Health Care Select Sector SPDR ETF slipped roughly 0.9% by midday.
Strive Specialties, a compounding pharmacy, has filed a lawsuit against Lilly and Novo in a federal Texas court. The complaint alleges the two companies use exclusive deals with telehealth providers to block doctors from prescribing compounded versions of their GLP-1 drugs. These compounding pharmacies create customized or mixed medicines and have supplied cheaper alternatives during drug shortages. Lilly responded by calling Strive’s claims “wrong, on both the facts and law,” suggesting the lawsuit is a distraction from Strive’s own practices. (Reuters)
Competition is heating up beyond the usual top two. On Wednesday, AbbVie announced plans to expand its obesity portfolio with an amylin-based drug licensed from Denmark’s Gubra. This candidate targets a hormone pathway distinct from GLP-1s, with AbbVie projecting the weight-loss market could hit around $150 billion annually within ten years. (Reuters)
Lilly investors are now watching to see if the April 10 target date sticks and what that might reveal about the FDA’s fast-track voucher program limits. A brief delay is still workable, but anything longer could hurt.
Drug reviews can stall, and slipping past spring risks squeezing the launch window, letting competitors secure prescribers and payers first. The legal battle with compounders clouds pricing and distribution even further, a hot button issue as patients increasingly seek cheaper alternatives.
Lilly’s quarterly earnings come up on Feb. 4, setting the stage for questions on the pill timeline, demand and supply for Zepbound and Mounjaro, and the company’s legal stance on copycat sales. (Lilly)
