Eli Lilly’s Promising Trial Data and Accelerated FDA Review Boosts Stock

Eli Lilly & Co (LLY) is experiencing positive market sentiment following the release of encouraging topline results from its ATTAIN-MAINTAIN trial, coupled with news of the FDA potentially expediting the review process for orforglipron.

The investigational oral GLP-1 receptor agonist shows promise in maintaining weight loss after initial treatment with injectable therapies, bolstering the company's position in the competitive obesity treatment market.

LLY stock is currently trading relatively comfortably above $1,000 at $1,041.98 in the pre-market after a relative month of calm in public markets.  This movement follows a significant rally that has seen LLY add more than 65% in a little over four months. The year-to-date gain of 33.89% marks Lilly out as one of the outperformers on the year, pushing market cap within touching distance of $1trillion this morning ($984.89billion).

Trial Results Breakdown

The ATTAIN-MAINTAIN trial evaluated orforglipron's efficacy in maintaining weight loss over 52 weeks in individuals who previously underwent 72 weeks of treatment with Wegovy or Zepbound. Notably, participants transitioning to orforglipron from Wegovy maintained nearly all their prior weight loss, with an average difference of 0.9 kg. Those switching from Zepbound maintained an average difference of 5 kg. The safety profile remained consistent with earlier studies, primarily featuring mild-to-moderate gastrointestinal side effects. These findings suggest orforglipron could offer a convenient oral alternative for long-term weight management.

Further fueling market optimism, the FDA is reportedly considering accelerating the review timeline for orforglipron, potentially leading to a decision as early as March 28, 2026, ahead of the initial May 20 deadline. This expedited review is supported by a Commissioner's National Priority Voucher obtained by Lilly as part of a pricing agreement, reflecting the urgency and importance placed on innovative obesity treatments.

Prior to these developments, Eli Lilly announced results from the ATTAIN-1 and ATTAIN-2 trials. The ATTAIN-1 trial, involving adults with obesity or overweight without diabetes, revealed that participants receiving the highest dose of orforglipron (36 mg) experienced an average weight loss of 12.4% (27.3 lbs) over 72 weeks, along with improvements in cardiovascular risk factors. The ATTAIN-2 trial, focusing on adults with obesity or overweight and type 2 diabetes, demonstrated an average weight loss of 10.5% (22.9 lbs) and a reduction in A1C levels by 1.8% over 72 weeks.

Orforglipron's positive trial results position it as a strong competitor in the obesity treatment market, offering an oral alternative to injectable GLP-1 therapies. While Novo Nordisk's oral semaglutide has demonstrated a slightly higher weight reduction of 16.6% in trials, orforglipron's favorable safety profile and convenient once-daily administration without food or water restrictions could provide a competitive advantage.

The potential for expedited FDA approval and the promising clinical trial outcomes have contributed to positive investor sentiment regarding Eli Lilly's stock. Bull Case:

While competition remains a factor and regulatory hurdles must be cleared, the convenience of an oral treatment and positive trial results present a compelling case. However, the stock's high valuation means that future performance will ultimately depend on flawless execution, successful commercialization, and widespread market adoption.