Eli Lilly's Orforglipron Nears Approval as Weight Loss Trial Data Exceeds Expectations

Eli Lilly reported positive data for its oral GLP-1 drug candidate, orforglipron, in the Attain-2 study, achieving 8.3% placebo-adjusted weight loss at 72 weeks. The data supports Lilly's on-schedule regulatory filings for orforglipron, which is expected to be approved later this year. Lilly shares rose nearly 5%, while Novo Nordisk shares fell a similar amount. The company maintains its $650 fair value estimate and wide-moat rating for Lilly.

Eli Lilly (LLY) reported positive data for its oral GLP-1 drug candidate, orforglipron, in the Attain-2 study, achieving 8.3% placebo-adjusted weight loss at 72 weeks. This data supports Lilly's on-schedule regulatory filings for orforglipron, which is expected to be approved later this year. Lilly shares rose nearly 5% in intraday trading, while Novo Nordisk (NVO) shares fell a similar amount. Morningstar analysts maintain their $650 fair value estimate and wide-moat rating for Lilly, considering peak tirzepatide sales of over $60 billion and $20 billion for orforglipron.

The Attain-2 study, which involved 1,600 participants with obesity or overweight and Type 2 diabetes, demonstrated that orforglipron's 36 mg dose achieved an average weight loss of 22.9 pounds over 72 weeks. This result, while slightly below the 11.5% placebo-adjusted weight loss observed in the Attain-1 study, is promising compared to other trials. For instance, Wegovy's 68-week placebo-adjusted weight loss was 7.5%, and 25 mg oral semaglutide's total weight loss was 7% in the Pioneer Plus trial.

The company's shares reacted positively to the news, indicating investor confidence in Lilly's ability to secure regulatory approval for orforglipron. However, Morningstar analysts caution that Novo's oral semaglutide may still be a significant competitor in the US oral obesity market, with approval expected ahead of Lilly and slightly stronger data in its main obesity/overweight trial. Despite this, Lilly's easier manufacturing process for orforglipron could allow for a more rapid global launch.

In summary, Eli Lilly's orforglipron achieved promising results in the Attain-2 study, supporting its regulatory filings and maintaining investor confidence in the company's stock. The data also highlights Lilly's competitive position in the growing oral obesity market.

References:
[1] https://www.morningstar.com/stocks/eli-lilly-strong-orforglipron-data-second-obesity-trial-support-on-schedule-regulatory-filings
[2] https://seekingalpha.com/news/4489112-eli-lilly-posts-phase-3-trial-win-obesity-pill
[3] https://www.ainvest.com/news/eli-lilly-orforglipron-achieves-10-5-weight-loss-phase-3-trial-2508/