Eli Lilly Receives Approval for GLP-1 Pill Foundayo
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
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Should l Buy LLY?
Source: Fool
- Drug Approval Impact: Eli Lilly received approval for its GLP-1 pill Foundayo on April 1, and while it is not the first to market, this approval presents a significant growth opportunity for the company, likely expanding its customer base.
- Revenue Growth Potential: Last year, Eli Lilly's total revenue rose by 45% to $65.2 billion, with injectable drug Zepbound contributing $13.5 billion and growing by 175%, and the launch of Foundayo is expected to further enhance this growth momentum.
- Market Reaction Analysis: Although the approval of Foundayo provided a short-term boost to Eli Lilly's stock, concerns over high valuation, with a P/E ratio exceeding 40, may be suppressing further price increases, as the current stock price stands at $937.18.
- Future Outlook: Eli Lilly has a bright future in the GLP-1 space, and in addition to Foundayo, the company boasts a rich pipeline with numerous late-stage trials, making it a worthwhile healthcare stock for long-term investment.
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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: 939.470
Low
950.00
Averages
1192
High
1500
Current: 939.470
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.
- Drug Approval Impact: Eli Lilly received approval for its GLP-1 pill Foundayo on April 1, and while it is not the first to market, this approval presents a significant growth opportunity for the company, likely expanding its customer base.
- Revenue Growth Potential: Last year, Eli Lilly's total revenue rose by 45% to $65.2 billion, with injectable drug Zepbound contributing $13.5 billion and growing by 175%, and the launch of Foundayo is expected to further enhance this growth momentum.
- Market Reaction Analysis: Although the approval of Foundayo provided a short-term boost to Eli Lilly's stock, concerns over high valuation, with a P/E ratio exceeding 40, may be suppressing further price increases, as the current stock price stands at $937.18.
- Future Outlook: Eli Lilly has a bright future in the GLP-1 space, and in addition to Foundayo, the company boasts a rich pipeline with numerous late-stage trials, making it a worthwhile healthcare stock for long-term investment.
See More
- Clinical Trial Results: Eli Lilly's non-covalent BTK inhibitor Jaypirca, when combined with Venclexta and rituximab, demonstrated improved progression-free survival in chronic lymphocytic leukemia patients compared to Venclexta and rituximab alone, indicating its potential therapeutic advantage.
- Treatment Duration: Patients in both arms received treatment for up to two years, providing a robust timeframe for assessing the drug's long-term effects, which could influence future treatment decisions.
- Survival Rate Trends: Although data on overall survival as a secondary endpoint is not yet mature, the trend favors the Jaypirca-treated cohort, highlighting the drug's potential in improving patient survival rates and attracting further interest.
- Regulatory Submission Plans: Eli Lilly intends to submit the data to the US FDA and other regulators later this year for label expansion, a move that could broaden Jaypirca's market applications and enhance the company's competitiveness in the hematologic cancer treatment space.
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- Clinical Trial Success: Eli Lilly's BRUIN CLL-322 Phase 3 study results indicate that the combination of Jaypirca with venetoclax and rituximab significantly improves progression-free survival in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), highlighting the combination therapy's substantial potential in treating this challenging condition.
- Primary Endpoint Achieved: The study met its primary endpoint, with independent review confirming that the addition of Jaypirca consistently demonstrated efficacy across key patient subgroups, particularly among those previously treated with a covalent BTK inhibitor, reinforcing its broad clinical applicability.
- Favorable Safety Profile: The safety profile of the combination therapy aligns with the known safety of the individual agents, indicating that Jaypirca can be safely combined with other treatments without introducing additional risks, thus providing confidence for its future clinical use.
- Label Expansion Plans: Eli Lilly intends to submit the data to regulators later this year to seek an expansion of Jaypirca's indication label, further advancing its application in chronic lymphocytic leukemia treatment and signaling the company's strategic focus in the oncology sector.
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- Trial Success: The BRUIN CLL-322 trial demonstrated that the combination of Jaypirca with venetoclax and rituximab significantly improved progression-free survival (PFS) in patients with chronic lymphocytic leukemia (CLL), marking a promising advancement in second-line treatment over a two-year therapy period.
- Relevant Patient Population: The trial predominantly enrolled patients previously treated with covalent BTK inhibitors, and results indicated significant PFS improvement regardless of prior treatment history, reinforcing Jaypirca's relevance in current clinical practice.
- Safety Profile: The trial results indicated that the safety profile of Jaypirca was consistent with known safety data, with similar rates of adverse events across treatment arms and low treatment discontinuation rates, highlighting its acceptability in clinical use.
- Future Prospects: Lilly intends to submit these results to regulators later this year for label expansion, aiming to enhance market access for Jaypirca, which is expected to provide more treatment options for patients with chronic lymphocytic leukemia.
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- Market Surge: According to Markets and Markets, the GLP-1 agonist market grew from $53.74 billion in 2024 to $64.42 billion in 2025, with projections reaching $170.75 billion by 2033, indicating a robust demand for obesity and diabetes treatments.
- New Drug Approval: In 2025, Novo Nordisk's Wegovy received FDA approval as the first oral GLP-1 weight-loss medication, marking a significant breakthrough in treatment options, particularly for those with trypanophobia, which is expected to further drive market demand.
- Top-Selling Drugs: In 2025, Mounjaro led the GLP-1 drug market with $22.97 billion in sales, followed by Ozempic and Zepbound with $20 billion and $13.54 billion, respectively, showcasing the strong appeal of GLP-1 therapies globally.
- Patent Protection and Competition: While Ozempic and Wegovy are protected by patents in the U.S. until around 2032, generics have already launched in India and are expected in China, intensifying market competition and potentially impacting the market share of original branded drugs.
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- Restaurant Sector Struggles: The rise of weight-loss drugs is suppressing consumer appetite, leading to challenges for the restaurant industry, as evidenced by Chipotle Mexican Grill's flat or negative same-store sales growth over the past four quarters, indicating a direct impact on dining expenditures.
- Market Transformation: Companies like Chipotle are launching new high-protein, low-calorie menu items to counter the impact of weight-loss drugs, and despite a 50% drop in stock price from its highs, a successful pivot could restore demand in the future.
- Fitness Industry Boom: The use of weight-loss drugs is encouraging exercise, with Planet Fitness experiencing a 171% revenue increase over the past five years and a 6.7% same-store sales growth in 2025, highlighting strong growth potential in the fitness sector.
- Future Outlook: Planet Fitness plans to open 180 to 190 new clubs in 2026, with same-store sales projected to grow by 4% to 5%, and while its stock has declined over the past five years, the overall increase in fitness spending presents a significant opportunity for market share expansion.
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