Eli Lilly Seeks FDA Approval for Oral Weight-Loss Drug Candidate

Eli Lilly US5324571083

Pharmaceutical giant Eli Lilly took a significant step on December 18, formally submitting an application to the U.S. Food and Drug Administration for its oral GLP-1 medication, orforglipron. This move could potentially reshape the competitive landscape of the obesity treatment market by offering a non-injectable alternative to a broader patient population.

Concurrent with its regulatory push, the company is adjusting its international commercial strategy. In Canada, the list prices for Mounjaro and Zepbound will be reduced by approximately 20 percent, effective December 29, 2025. This pricing shift appears focused on driving volume growth and securing market share ahead of potential future regulatory measures.

Notably, Eli Lilly was absent from a group of nine other drugmakers—including Amgen and Merck—that announced pricing agreements with the White House on December 19. The company had previously negotiated its own terms with the U.S. government in earlier months.

The Oral Contender in a Market Dominated by Injections

The obesity and weight-management sector is currently led by injectable therapies such as Zepbound and Wegovy. Orforglipron is designed as a once-daily oral tablet, specifically targeting patients who are reluctant or opposed to using injectable medications.

To expedite the review process, Eli Lilly utilized a Priority Review Voucher for its submission. The application is supported by data from the Phase 3 ATTAIN-MAINTAIN clinical trial. Results released this week indicated that patients who switched from injectable therapies to orforglipron were able to maintain their achieved weight loss compared to those on a placebo.

Institutional Investors Show Strong Confidence

Recent regulatory filings reveal substantial buying activity from major institutional investors following the company's strong third-quarter earnings report:

• Stillwater Capital Advisors increased its stake by a massive 2,684 percent in Q3, building a position of 34,271 shares valued at roughly $26.15 million.
• Dynamic Advisor Solutions boosted its holdings by nearly 55 percent, bringing the total value above $10 million.
• Sheets Smith Investment Management established a new position in the stock.

This influx of institutional capital came after Eli Lilly reported Q3 earnings per share of $7.02, soundly beating the consensus estimate of $6.42.

Market Valuation and Analyst Outlook

Eli Lilly shares are trading near their 52-week high of $1,111.99, commanding a price-to-earnings ratio of approximately 53. The company also recently raised its quarterly dividend to $1.73 per share.

Analysts at Daiwa Securities upgraded the stock to a "Buy" rating, assigning a price target of $1,230. The upgrade cites the significant pipeline potential of orforglipron and Eli Lilly's sustained dominance in the metabolic disease sector.

A regulatory decision from the FDA on orforglipron is anticipated in 2026. A successful approval would enable the company to capture a substantial segment of the patient market that has previously declined treatment due to the requirement for injections.