Eli Lilly (LLY) Faces Delay for Orforglipron Approval Now Set for April 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 15 2026
0mins
Source: seekingalpha
- FDA Approval Delay: Eli Lilly's weight loss pill orforglipron now faces an FDA approval delay until April 2026, which is a setback from initial expectations and has led to a ~5% drop in stock price, marking its largest intraday loss in five months.
- Priority Review Program: The FDA's National Priority Review voucher program aims to expedite the review of experimental therapies from 10-12 months to just 1-2 months; however, delays faced by two recipients are impacting Lilly's drug approval timeline.
- Increased Market Competition: As Lilly's approval timeline extends, rival Novo Nordisk has launched its weight loss drug Wegovy in the U.S. at $149 per month, intensifying competition and potentially affecting Lilly's market share in the obesity drug sector.
- Executive Expectations Adjustment: While CEO David Ricks previously indicated that orforglipron could be approved as early as Q1 2026, CFO Lucas Montarce has tempered those expectations, now projecting a Q2 2026 approval, reflecting a cautious outlook on the drug's market entry prospects.
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Analyst Views on LLY
Wall Street analysts forecast LLY stock price to rise
20 Analyst Rating
18 Buy
2 Hold
0 Sell
Strong Buy
Current: 934.600
Low
950.00
Averages
1192
High
1500
Current: 934.600
Low
950.00
Averages
1192
High
1500
About LLY
Eli Lilly and Company is a medicine company, which discovers, develops, manufactures, and market products in a single business segment called human pharmaceutical products. The Company manufacture and distribute its products through facilities in the United States, including Puerto Rico, and in Europe and Asia. The Company’s products are sold in approximately 90 countries. Its Cardiometabolic Health products Basaglar; Humalog, Humalog Mix 75/25, Humalog U-100, Humalog U-200, Humalog Mix 50/50, insulin lispro, and others; Humulin, Humulin 70/30, and others; Jardiance; Mounjaro; Trulicity; Zepbound, and others. Its oncology products include Cyramza, Erbitux, Tyvyt, Verzenio, Retevmo, Jaypirca, and others. Its immunology products include Ebglyss, Olumiant, Omvoh, and Taltz. Its neuroscience products include Emgality and Kisunla. Its LillyDirect, a direct-to-patient digital health care platform, provides delivery of select Lilly medicines dispensed by third-party pharmacies to patients.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Net Income Spike: Adjusted net income skyrocketed 155% to $7.7 billion, translating to $8.55 per share, significantly surpassing Wall Street's estimate of $6.79, reflecting the company's strong performance in the weight loss drug sector.
- Sales Growth Drivers: Sales of GLP-1 drugs Mounjaro and Zepbound surged 125% and 80%, reaching $8.7 billion and $4.2 billion respectively, becoming key growth drivers that further solidify the company's market leadership.
- Optimistic Outlook: Eli Lilly raised its 2023 revenue and adjusted EPS guidance to $82 billion to $85 billion and $35.50 to $37, indicating confidence in future growth, particularly with the newly launched GLP-1 pill Foundayo expected to expand market share.
See More
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- Patent Cliff Risks: The company is facing a series of upcoming patent expirations that could lead to significant revenue declines for key drugs, presenting a major challenge for management to maintain revenue stability.
- Innovative Drug Development: Pfizer has quickly pivoted by acquiring a company developing a weight-loss drug and partnering with a Chinese firm to distribute a GLP-1 drug if approved, demonstrating its proactive approach in the innovative pharmaceutical space.
- High Dividend Appeal: With a dividend yield of 6.4%, Pfizer offers a more attractive option for dividend investors compared to Eli Lilly's mere 0.6%, making it appealing in a market characterized by uncertainty.
See More
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- Declining Vaccine Demand: Pfizer is facing challenges due to a drop in demand for COVID vaccines, resulting in its stock price plummeting over 50% from its 2021 peak, which has led investors to adopt a cautious outlook on its future performance.
- Patent Cliff Risks: The company is approaching a series of patent expirations that are expected to lead to significant revenue declines for some of its key drugs, posing a threat to its financial health and market position.
- New Drug Development Progress: Despite these challenges, Pfizer has quickly pivoted by acquiring a company developing a weight-loss drug and partnering with a Chinese firm to distribute a GLP-1 drug, demonstrating its ongoing commitment to innovation in the pharmaceutical sector.
- Dividend Appeal: With a dividend yield of 6.4%, Pfizer remains an attractive option for income-seeking investors, especially when compared to competitors like Eli Lilly, which offers a mere 0.6% yield, despite the near-term uncertainties surrounding its drug pipeline.
See More
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- Surge in Market Demand: According to Gallup, the use of GLP-1 drugs has more than doubled since early 2024, with nearly 13% of U.S. adults currently using them, leading to increased demand for hair treatment products as the user base expands.
- Increased Consumer Spending: Research firm Circana reports that GLP-1 households spend approximately 30% more on beauty products than non-GLP-1 households, indicating that hair loss solutions have become a significant growth segment in the beauty industry amid ongoing consumer stress post-pandemic.
- Brand Innovation Response: Redken has launched an entire Acidic Grow Full System specifically designed for GLP-1 users, addressing their unique hair care needs and showcasing the brand's responsiveness to emerging market opportunities.
- Long-term Customer Loyalty: As hair treatment products often take months to show results, GLP-1 users are expected to exhibit high brand loyalty, providing ongoing commercial opportunities for companies in the hair care sector as the market continues to grow.
See More
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- Market Acceptance Analysis: Eli Lilly's oral GLP-1 drug Foundayo recorded 5,612 prescriptions in its third week, indicating low market acceptance, especially compared to Novo Nordisk's oral Wegovy, which had over 134,000 prescriptions in the same period, highlighting Wegovy's first-mover advantage.
- Patient Treatment Status: As of April 30, Eli Lilly executives reported that over 20,000 patients have been treated with Foundayo; however, this figure appears weak compared to Wegovy's market performance, potentially leading to negative investor sentiment.
- Future Expectations: RBC Capital Markets analyst Trung Huynh expects Foundayo to exceed 90,000 prescriptions by week 12 to stay on track for its annual sales expectation of about $1.4 billion, and achieving this target will directly impact Eli Lilly's market performance and investor confidence.
- Financial Outlook: Eli Lilly projects revenues of $82 billion to $85 billion by 2026, with non-GAAP EPS expected between $35.50 and $37, positioning Foundayo's launch as a crucial component for achieving these targets, despite its current underwhelming market performance.
See More
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- Apple's Impressive Earnings: Apple's second-quarter revenue surged 17% to $111.2 billion, surpassing the $109.7 billion estimate, with strong guidance boosting investor confidence and suggesting further stock price increases ahead.
- Eli Lilly's Strong Performance: Eli Lilly's shares rose another 3% following a nearly 10% rally post-earnings, with a remarkable 56% year-over-year revenue increase to $19.8 billion, leading Jim Cramer to assert that selling the stock would be premature.
- Investor Strategy Advice: Jim Cramer advises investors to tune into Apple's earnings call, emphasizing a strategy of holding rather than trading, as he believes there is significant room for the stock to grow, reflecting optimism about its future prospects.
See More
