FDA Proposes Exclusion of Weight Loss Drug Ingredients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 30 2026
0mins
Should l Buy LLY?
Source: stocktwits
- FDA Proposal: The U.S. Food and Drug Administration (FDA) has proposed to exclude Semaglutide and Tirzepatide from the 503B bulk list, limiting the compounding capabilities of outsourcing facilities, which may impact the market supply and accessibility of these drugs.
- Insufficient Clinical Need: The FDA stated that after reviewing available data, it found no clear clinical need to allow compounding of these drugs from raw ingredients, emphasizing patient safety and medical necessity, which could lead to restrictions on the use of related medications.
- Quality and Safety Concerns: The FDA has expressed concerns regarding the quality and safety of compounded weight-loss drugs, noting that these drugs are not reviewed by the FDA, which may pose risks such as improper storage, dosing errors, and counterfeit products, thereby affecting patient health.
- Market Reaction: Following the FDA proposal, shares of Eli Lilly and Novo Nordisk rose by 9% and 5%, respectively, indicating increased market confidence in the FDA-approved drugs from these companies, while Hims & Hers and Teladoc Health saw slight declines, reflecting market concerns over compounded medications.
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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: 974.960
Low
950.00
Averages
1192
High
1500
Current: 974.960
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.
Eli Lilly's Foundayo Prescription Growth Amidst Market Competition
- Prescription Growth: Eli Lilly's new obesity pill Foundayo reached 7,335 prescriptions in its fourth week, indicating a slight increase from the previous week, reflecting a gradual acceptance in the market despite trailing behind competitor Novo Nordisk's Wegovy.
- Market Competition Analysis: In its third week, Foundayo had 5,612 prescriptions, while Wegovy surpassed 28,000 prescriptions in the same period, highlighting the intense competition Eli Lilly faces in the oral obesity drug market, necessitating enhanced marketing efforts.
- Investor Confidence Rebound: Despite initial lower prescription data, RBC Capital Markets analyst Trung Huynh noted that investors are beginning to focus on Foundayo's long-term potential, suggesting that short-term prescription metrics may not fully capture its future performance.
- Market Outlook: Eli Lilly raised its market outlook in its Q1 2026 earnings report, with CEO Dave Ricks stating that the rollout of Foundayo will be “just fine,” revealing that over 20,000 patients have initiated therapy in the early weeks, indicating strong market acceptance.
See More
Novo Nordisk and Eli Lilly Compete Intensely as Oral Weight Loss Drug Market Emerges
- Market Share Shift: Eli Lilly has captured a 60% share of the U.S. GLP-1 drug market, surpassing Novo Nordisk, indicating strong performance that is expected to continue driving revenue growth for the company.
- New Drug Approvals: Novo Nordisk's oral Wegovy garnered 1.3 million prescriptions in its first quarter, achieving a 65% market share, while Lilly's Foundayo has treated over 20,000 patients since its April 9 launch, reflecting strong demand for oral medications.
- Sales Growth Potential: Novo's oral Wegovy benefits from familiarity as a pill version of its injectable drug, while Lilly's Foundayo may attract more patients due to its convenience of no dietary restrictions, indicating significant future sales potential.
- Optimistic Industry Outlook: Although Novo Nordisk leads in the oral drug market, both companies are poised to benefit from the growing demand for weight loss medications, suggesting strong interest in oral formulations that could drive growth for both players.
See More
Eli Lilly and Novo Nordisk Compete in Weight Loss Drug Market
- Market Share Shift: Eli Lilly has captured a 60% share of the U.S. market, surpassing Novo Nordisk, indicating strong performance in the weight loss drug sector, particularly as its Zepbound product outperformed Novo's Wegovy in head-to-head studies.
- New Drug Approvals: Novo Nordisk's oral Wegovy received approval in December, generating 1.3 million prescriptions in its first quarter, capturing 65% of new prescriptions, while Eli Lilly's Foundayo launched on April 9 and has treated over 20,000 patients, reflecting strong demand for oral formulations.
- Revenue Growth: Eli Lilly's Zepbound saw an 80% revenue increase to $4 billion in the recent quarter, contributing to nearly $20 billion in total revenue, showcasing the product's popularity and profitability in the market.
- Competitive Advantage: Although Novo Nordisk's oral Wegovy currently leads, Eli Lilly's Foundayo offers no dietary restrictions, potentially attracting more patients and indicating a competitive edge in convenience, suggesting that future market competition will intensify.
See More
Lilly Launches Foundayo with Soft Market Reception Compared to Wegovy
- Market Performance Comparison: Lilly's oral obesity drug Foundayo generated 7,335 prescriptions in its fourth week in the U.S. market, significantly lower than Novo Nordisk's Wegovy, which recorded 28,515 prescriptions in the same period, indicating a weaker market reception that could impact Lilly's sales expectations.
- Sales Expectation Challenges: RBC Capital Markets analyst Trung Huynh noted that Foundayo's weekly prescription volume needs to rise significantly to 22,000 to meet Wall Street's consensus expectation of $160 million in second-quarter sales, making this target crucial for Lilly's market performance.
- Clinical Trial Results: In a late-stage trial, patients taking Foundayo lost an average of 27.3 pounds (12.4%), compared to just 2.2 pounds (0.9%) in the placebo group, demonstrating the drug's potential in weight loss and cardiovascular risk reduction, which may attract more patients.
- Market Sentiment Shift: With the rise of oral obesity medications, the FDA approved Foundayo in April, marking a significant innovation in this field; however, retail sentiment around Lilly shifted from 'bullish' to 'neutral' in the past 24 hours, reflecting investor concerns about its market performance.
See More
Eli Lilly's Foundayo Prescription Analysis
- Prescription Performance: Eli Lilly's Foundayo was prescribed 7,335 times in the U.S. during its fourth week, indicating modest uptake compared to rival Novo Nordisk's Wegovy, yet still reflecting initial market acceptance.
- Market Potential Outlook: Analyst Trung Huynh noted that despite weaker prescription numbers, investors are beginning to focus on Foundayo's future potential, believing that the next generation of weight-loss pills could attract millions of patients and alleviate pricing pressures.
- Prescription Demand Forecast: To meet the consensus expectation of $160 million in second-quarter sales, Foundayo needs approximately 22,000 prescriptions per week, highlighting the urgency for increased market acceptance.
- Broad Availability: Foundayo was approved in the U.S. on April 1, with shipping starting on April 6 and broad availability through retail pharmacies and telehealth providers beginning on April 9, demonstrating the company's commitment to market penetration.
See More
Can Eli Lilly Reclaim a $1 Trillion Market Cap?
- Market Leadership: Eli Lilly's leadership in the weight loss market positions it to potentially achieve an 11.7% compound annual growth rate over the next seven years; despite facing intense competition, its robust pipeline of candidates could support significant clinical progress, which may drive a rebound in its stock price.
- Diversification Strategy: Eli Lilly has significantly expanded its drug pipeline through acquisitions, particularly with breakthroughs in Alzheimer's disease, such as the approval of Kisunla, which has positively impacted its stock; further successes in other therapeutic areas could enhance the company's stock performance.
- AI Technology Investment: Eli Lilly has built the most powerful AI supercomputer in the pharmaceutical industry in partnership with Nvidia, and while AI may not transform the business overnight, even modest productivity gains could have a meaningful impact on the company's operations in the coming years.
- Long-Term Growth Potential: Even if Eli Lilly does not meet every growth criterion, its dominance in the weight loss market and extensive drug pipeline suggest strong financial performance ahead, and its impressive dividend growth over the past five years adds to its attractiveness for investors.
See More
Eli Lilly's Foundayo Prescription Growth Amidst Market Competition
- Prescription Growth: Eli Lilly's new obesity pill Foundayo reached 7,335 prescriptions in its fourth week, indicating a slight increase from the previous week, reflecting a gradual acceptance in the market despite trailing behind competitor Novo Nordisk's Wegovy.
- Market Competition Analysis: In its third week, Foundayo had 5,612 prescriptions, while Wegovy surpassed 28,000 prescriptions in the same period, highlighting the intense competition Eli Lilly faces in the oral obesity drug market, necessitating enhanced marketing efforts.
- Investor Confidence Rebound: Despite initial lower prescription data, RBC Capital Markets analyst Trung Huynh noted that investors are beginning to focus on Foundayo's long-term potential, suggesting that short-term prescription metrics may not fully capture its future performance.
- Market Outlook: Eli Lilly raised its market outlook in its Q1 2026 earnings report, with CEO Dave Ricks stating that the rollout of Foundayo will be “just fine,” revealing that over 20,000 patients have initiated therapy in the early weeks, indicating strong market acceptance.
See More
Novo Nordisk and Eli Lilly Compete Intensely as Oral Weight Loss Drug Market Emerges
- Market Share Shift: Eli Lilly has captured a 60% share of the U.S. GLP-1 drug market, surpassing Novo Nordisk, indicating strong performance that is expected to continue driving revenue growth for the company.
- New Drug Approvals: Novo Nordisk's oral Wegovy garnered 1.3 million prescriptions in its first quarter, achieving a 65% market share, while Lilly's Foundayo has treated over 20,000 patients since its April 9 launch, reflecting strong demand for oral medications.
- Sales Growth Potential: Novo's oral Wegovy benefits from familiarity as a pill version of its injectable drug, while Lilly's Foundayo may attract more patients due to its convenience of no dietary restrictions, indicating significant future sales potential.
- Optimistic Industry Outlook: Although Novo Nordisk leads in the oral drug market, both companies are poised to benefit from the growing demand for weight loss medications, suggesting strong interest in oral formulations that could drive growth for both players.
See More
Eli Lilly and Novo Nordisk Compete in Weight Loss Drug Market
- Market Share Shift: Eli Lilly has captured a 60% share of the U.S. market, surpassing Novo Nordisk, indicating strong performance in the weight loss drug sector, particularly as its Zepbound product outperformed Novo's Wegovy in head-to-head studies.
- New Drug Approvals: Novo Nordisk's oral Wegovy received approval in December, generating 1.3 million prescriptions in its first quarter, capturing 65% of new prescriptions, while Eli Lilly's Foundayo launched on April 9 and has treated over 20,000 patients, reflecting strong demand for oral formulations.
- Revenue Growth: Eli Lilly's Zepbound saw an 80% revenue increase to $4 billion in the recent quarter, contributing to nearly $20 billion in total revenue, showcasing the product's popularity and profitability in the market.
- Competitive Advantage: Although Novo Nordisk's oral Wegovy currently leads, Eli Lilly's Foundayo offers no dietary restrictions, potentially attracting more patients and indicating a competitive edge in convenience, suggesting that future market competition will intensify.
See More
Lilly Launches Foundayo with Soft Market Reception Compared to Wegovy
- Market Performance Comparison: Lilly's oral obesity drug Foundayo generated 7,335 prescriptions in its fourth week in the U.S. market, significantly lower than Novo Nordisk's Wegovy, which recorded 28,515 prescriptions in the same period, indicating a weaker market reception that could impact Lilly's sales expectations.
- Sales Expectation Challenges: RBC Capital Markets analyst Trung Huynh noted that Foundayo's weekly prescription volume needs to rise significantly to 22,000 to meet Wall Street's consensus expectation of $160 million in second-quarter sales, making this target crucial for Lilly's market performance.
- Clinical Trial Results: In a late-stage trial, patients taking Foundayo lost an average of 27.3 pounds (12.4%), compared to just 2.2 pounds (0.9%) in the placebo group, demonstrating the drug's potential in weight loss and cardiovascular risk reduction, which may attract more patients.
- Market Sentiment Shift: With the rise of oral obesity medications, the FDA approved Foundayo in April, marking a significant innovation in this field; however, retail sentiment around Lilly shifted from 'bullish' to 'neutral' in the past 24 hours, reflecting investor concerns about its market performance.
See More
Eli Lilly's Foundayo Prescription Analysis
- Prescription Performance: Eli Lilly's Foundayo was prescribed 7,335 times in the U.S. during its fourth week, indicating modest uptake compared to rival Novo Nordisk's Wegovy, yet still reflecting initial market acceptance.
- Market Potential Outlook: Analyst Trung Huynh noted that despite weaker prescription numbers, investors are beginning to focus on Foundayo's future potential, believing that the next generation of weight-loss pills could attract millions of patients and alleviate pricing pressures.
- Prescription Demand Forecast: To meet the consensus expectation of $160 million in second-quarter sales, Foundayo needs approximately 22,000 prescriptions per week, highlighting the urgency for increased market acceptance.
- Broad Availability: Foundayo was approved in the U.S. on April 1, with shipping starting on April 6 and broad availability through retail pharmacies and telehealth providers beginning on April 9, demonstrating the company's commitment to market penetration.
See More
Can Eli Lilly Reclaim a $1 Trillion Market Cap?
- Market Leadership: Eli Lilly's leadership in the weight loss market positions it to potentially achieve an 11.7% compound annual growth rate over the next seven years; despite facing intense competition, its robust pipeline of candidates could support significant clinical progress, which may drive a rebound in its stock price.
- Diversification Strategy: Eli Lilly has significantly expanded its drug pipeline through acquisitions, particularly with breakthroughs in Alzheimer's disease, such as the approval of Kisunla, which has positively impacted its stock; further successes in other therapeutic areas could enhance the company's stock performance.
- AI Technology Investment: Eli Lilly has built the most powerful AI supercomputer in the pharmaceutical industry in partnership with Nvidia, and while AI may not transform the business overnight, even modest productivity gains could have a meaningful impact on the company's operations in the coming years.
- Long-Term Growth Potential: Even if Eli Lilly does not meet every growth criterion, its dominance in the weight loss market and extensive drug pipeline suggest strong financial performance ahead, and its impressive dividend growth over the past five years adds to its attractiveness for investors.
See More
