Eli Lilly and Co. (NYSE:LLY) shares climbed in Friday premarket trading after surging about 10% Thursday, fueled by stronger-than-expected first-quarter results and raised fiscal 2026 guidance.
The drugmaker reported adjusted earnings of $8.55 per share, topping analyst estimates of $6.66, while revenue rose to $19.79 billion versus expectations of $17.62 billion.
Eli Lilly also raised its full-year revenue outlook by $2 billion, driven by strong demand for blockbuster drugs Mounjaro and Zepbound.
FDA To Restrict Compounding Of Popular GLP-1 Drugs
On Thursday, the U.S. Food and Drug Administration (FDA) proposed excluding semaglutide, tirzepatide, and liraglutide from its 503B bulks list.
Semaglutide is the key ingredient in Novo Nordisk A/S‘ (NYSE:NVO) Ozempic and Wegovy. Liraglutide is available under the Victoza and Saxenda brand names.
Tirzepatide is available as Eli Lilly’s Mounjaro and Zepbound.
The agency concluded that there is no clinical need to outsource facilities to compound these drugs from bulk substances when approved versions are available.
The decision signals tighter regulatory oversight of compounded versions of widely used GLP-1 therapies.
What The 503B Bulks List Means
The 503B bulks list outlines which bulk drug substance outsourcing facilities can use for compounding under Section 503B of the Federal Food, Drug, and Cosmetic Act.
In most circumstances, outsourcing facilities are prohibited from compounding drugs using bulk substances unless those substances are explicitly included on the list or the drug is listed on the FDA's drug shortage database at the time of compounding, distribution, and dispensing.
By proposing to exclude these three substances, the FDA is effectively limiting outsourcing facilities’ ability to produce compounded versions outside of shortage scenarios.
FDA Cites Lack Of Clinical Need
After reviewing nominations for semaglutide, tirzepatide, and liraglutide, the agency determined there is insufficient evidence of a clinical need to justify compounding from bulk drug substances.
How Eli Lilly Ranks On Value, Growth And Quality
Below is the Benzinga Edge scorecard for Eli Lilly, highlighting its strengths and weaknesses compared to the broader market:
- Value: 6.13 — Indicates a relatively stable valuation.
- Growth: 99.11 — Suggests strong growth potential.
- Quality: 96.61 — Reflects high-quality metrics.
- Momentum: 44.25 — Indicates moderate momentum.
The Verdict: Eli Lilly’s Benzinga Edge signal reveals a growth-heavy profile, with strong quality metrics supporting its market position. The company is well-positioned to leverage its growth potential in the pharmaceutical sector.
Top ETFs Holding Eli Lilly Stock (LLY)
- iShares Global Healthcare ETF (NYSE:IXJ): 9.50% Weight
- Simplify Health Care ETF (NYSE:PINK): 6.63% Weight
- Polen Focus Growth ETF (NYSE:PCLG): 6.04% Weight
LLY Stock Price Activity: Eli Lilly shares were up 0.52% at $939.49 during premarket trading on Friday, according to Benzinga Pro data.
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