Eli Lilly's Orforglipron Approval Delayed to April
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 24 2026
0mins
Source: NASDAQ.COM
- Approval Delay: Eli Lilly's oral GLP-1 candidate, orforglipron, has seen its FDA review timeline extended from the end of February to April 10, resulting in a roughly 4% drop in the company's stock price in one day, indicating a negative market reaction to the news.
- Intensifying Competition: Novo Nordisk has already launched its oral Wegovy after receiving approval in December, positioning itself to capture market share from patients hesitant about injectable options, thereby increasing competitive pressure on Eli Lilly.
- Positive Market Outlook: Despite the delay in orforglipron's approval, Eli Lilly maintains a strong leadership position in the weight loss market, with an attractive mid- and late-stage pipeline in its core therapeutic area, indicating long-term potential in the rapidly growing sector.
- Strong Financial Performance: Eli Lilly's financial results remain robust, and the company offers a generous dividend program, suggesting that the market may have overreacted to the FDA's extended review, with the stock still viewed as a buying opportunity.
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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: 1041.650
Low
950.00
Averages
1192
High
1500
Current: 1041.650
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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- Intensifying Market Competition: Novo Nordisk's weight-loss pill Wegovy has received a recommendation for approval from the European Medicines Agency, becoming the first oral weight-loss drug in Europe, highlighting intensified competition with U.S. rival Eli Lilly as the obesity drug market is projected to reach $150 billion in the next decade.
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- Intensifying Market Competition: Novo Nordisk's weight-loss pill Wegovy has received a recommendation for approval from the European Medicines Agency, becoming the first oral weight-loss drug in Europe, highlighting intensified competition with U.S. rival Eli Lilly as the obesity drug market is projected to reach $150 billion in the next decade.
- Significant Clinical Trial Results: In a late-stage study, patients taking the 25-milligram Wegovy pill lost an average of 16.6% of their body weight compared to just 2.7% for the placebo group, demonstrating the drug's effectiveness in weight loss, which may attract more patients to oral treatments.
- Market Expansion Potential: Following its U.S. launch, Wegovy gained an early market advantage after FDA approval, while Lilly's weight-loss pill Zepbound was also launched in April, indicating that oral treatments could draw in new patients and drive market expansion rather than merely switching users from injections.
- Regulatory Review Process: The EMA's recommendation will be reviewed by the European Commission for marketing authorization, with expectations that the regulatory review of this new generation of weight-loss pills will conclude this summer, further advancing Novo Nordisk's market positioning.
See More
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- Clinical Trial Results: Eli Lilly's Phase 3 LIBRETTO-432 study demonstrates significant event-free survival outcomes for Retevmo (selpercatinib) in RET fusion-positive NSCLC patients, likely enhancing the drug's market acceptance and sales growth.
- New Drug Presentation: Verzenio (abemaciclib) has been selected for a Plenary Session presentation in the Phase 3 SARC041 study for patients with advanced dedifferentiated liposarcoma, indicating Lilly's ongoing innovation and exploration of new indications in cancer treatment.
- Acquisition Progress: Lilly has agreed to acquire Kelonia Therapeutics, which will present updated data on its BCMA-targeted CAR-T therapy for relapsed multiple myeloma at the conference, further strengthening Lilly's competitive position in cell therapy.
- Diverse Investments: Lilly will also showcase initial clinical results for an investigational ADC targeting Nectin-4, highlighting its potential in treating various cancers and reflecting the company's broad investment and commitment to oncology research and development.
See More
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- Strong Sector Performance: The healthcare sector has shown remarkable performance, with the State Street Health Care Select Sector SPDR ETF (XLV) rising 3.3% over the past week, significantly outperforming the S&P 500's 0.5% gain, indicating a robust rebound and renewed investor confidence in healthcare stocks.
- Drug Innovation Driving Prices: Merck (MRK) saw a substantial stock price increase after announcing a lung cancer drug that reduced tumor progression risk by 65% in a Phase 3 study, highlighting the positive impact of ongoing pharmaceutical innovation on stock valuations.
- Favorable Medicare Policies: The Centers for Medicare and Medicaid Services announced that starting in 2027, Eli Lilly's (LLY) GLP-1 drugs will be available to Medicare patients for $50 a month, resulting in a 25% stock price increase for Lilly over three weeks, demonstrating the direct support of policy changes for healthcare stocks.
- Aging Population Trend: The global aging population is driving increased demand for pharmaceuticals, medical devices, and health insurance, positioning the healthcare sector as a focal point for investors seeking growth opportunities in the face of demographic shifts.
See More
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- Pharmaceutical Innovation: Merck (MRK) saw its stock rise 5.63% this week after announcing a 65% reduction in tumor progression risk from a lung cancer drug developed with a Chinese partner in a Phase 3 study, highlighting the ongoing innovation within the pharmaceutical sector.
- Favorable Insurance Policies: The Centers for Medicare and Medicaid Services announced that Eli Lilly's (LLY) GLP-1 drugs will be available to Medicare patients for $50 a month starting January 2027, leading to a 25% stock price increase for Lilly over three weeks, showcasing the positive impact of policy changes on company performance.
- Aging Population Trend: The global aging population is driving increased demand for pharmaceuticals and medical services, positioning the healthcare sector for robust growth and attracting investors to healthcare ETFs as a safer investment choice amid economic uncertainties.
See More
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- New Chairman Sworn In: Kevin Warsh was sworn in as the 17th chairman of the Federal Reserve on Friday, succeeding Jerome Powell, who served for eight years, with President Trump officiating the ceremony, indicating strong trust and expectations for Warsh's leadership.
- Commitment to Independence and Integrity: Trump emphasized that Warsh should maintain “total independence” while leading the Fed and aims to restore the institution's integrity, reflecting urgent demands for reform in current monetary policy.
- Economic Growth Outlook: Warsh pledged to fulfill his role with “energy and purpose,” stating that pursuing maximum employment and price stability could lead to unprecedented prosperity for America, showcasing an optimistic view of future economic conditions.
- Market Reaction and Rate Expectations: As Warsh takes office, traders are increasing bets that the Federal Reserve will raise its benchmark rate by the end of the year, highlighting the market's keen interest and uncertainty regarding future monetary policy directions.
See More
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- Cancer Patient Benefits: Recent studies suggest that patients using GLP-1 drugs like Novo Nordisk's Ozempic and Eli Lilly's Mounjaro experience significantly reduced tumor progression, particularly among early-stage cancer patients, indicating improved survival rates and lower recurrence risks.
- Supporting Research Data: A study from the Cleveland Clinic tracked over 10,000 early-stage cancer patients, revealing that GLP-1 users had a cancer spread rate of only 10%, compared to 22% in the control group, demonstrating the drugs' significant advantages in controlling cancer progression.
- Breast Cancer Survival Rates: An analysis from the University of Texas MD Anderson Cancer Center found that over 95% of GLP-1 users were alive five years post-diagnosis, while non-users had a survival rate of only 89.5%, further emphasizing the potential long-term benefits of GLP-1 drugs.
- Significant Market Impact: The health benefits of GLP-1 drugs extend beyond blood sugar reduction and weight loss to include lower risks of heart attacks and strokes, positioning Novo Nordisk and Eli Lilly as two of the world's most valuable pharmaceutical companies, likely attracting further investment.
See More
