TLDR
- Eli Lilly stock dropped 5% after the FDA delayed approval of its weight-loss pill Orforglipron until April 10
- The FDA previously planned to decide on the obesity treatment by late March
- The delay gives competitor Novo Nordisk more time to build market share with its Wegovy pill, approved late last year
- Orforglipron was part of the Trump administration’s fast-track review program for critical medications
- Wall Street maintains a Strong Buy rating on LLY with analysts setting an average price target implying 16.91% upside
Eli Lilly stock fell 5% on Wednesday after federal regulators delayed their decision on the company’s weight-loss pill Orforglipron. The FDA pushed back its approval timeline to April 10.
The agency had previously planned to make a call by late March. The delay extends uncertainty around one of Eli Lilly’s most anticipated product launches.
Orforglipron was included in the Trump administration’s fast-track review program. This initiative promised decisions within one or two months for select medications deemed critical to public health or national security.
The pharmaceutical regulator did not provide specific reasons for the postponed decision date. Such delays typically allow more time for regulatory review and evaluation of clinical data.
Competitive Pressure Mounts
The timing creates a window for Novo Nordisk to expand its foothold in the oral weight-loss market. The FDA approved Novo’s Wegovy pill for U.S. sale in late 2025.
Novo Nordisk has been rolling out its weight-loss pill aggressively in recent weeks. The Danish pharmaceutical company now has several months to capture patients before Eli Lilly’s potential market entry.
Weight-loss pills represent a major shift from injectable medications. Pills are expected to appeal to a broader audience, particularly those uncomfortable with needles.
Industry analysts project the weight-loss pill market could reach over $150 billion in annual sales within the next decade. Both companies are racing to establish dominance in this emerging category.
Stock Performance and Analyst Views
Eli Lilly shares have declined 4.4% year-to-date. The stock currently trades at $1,032 per share, close to its 52-week high of $1,110 reached in November 2025.
Despite the recent drop, Wall Street remains bullish on LLY. Twenty analysts covering the stock maintain a consensus Strong Buy rating.
The rating reflects 18 Buy recommendations and two Hold ratings issued over the past three months. No analysts currently recommend selling the stock.
The average price target among Wall Street analysts stands at $1,192.17. This target suggests potential upside of 16.91% from current trading levels.
Earlier this month, Eli Lilly announced a partnership with Nimbus Therapeutics to develop oral obesity drugs. The deal included $55 million upfront and up to $1.3 billion in milestone payments.
The company was also reported to be in advanced talks to acquire Ventyx Biosciences for over $1 billion. These moves signal Eli Lilly’s commitment to expanding its obesity treatment pipeline beyond current offerings.
Investors who purchased $1,000 in Eli Lilly shares five years ago would see their investment worth $5,412 today. The FDA’s April 10 decision date will be a key catalyst for the stock in coming months.
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