Eli Lilly (LLY) Says FDA Requests Additional Data on Obesity Pill

Eli Lilly and Company (NYSE:LLY) is one of the 10 Best Stocks to Buy for the Next Decade.

On April 15, 2026, Eli Lilly and Company (NYSE:LLY) disclosed that the U.S. FDA had requested additional data related to potential liver injury associated with its newly approved obesity pill, along with post-marketing studies on cardiovascular risks and gastric emptying, according to a Reuters report. The agency also required a lactation study as part of its ongoing safety monitoring under the drug’s priority review approval. A Lilly spokesperson said there were no indications of liver damage in late-stage trials, adding that “The FDA approved Foundayo based on its review of data from the ATTAIN clinical program,” with post-approval requirements consistent with standard safety evaluation practices.

On April 12, 2026, Lilly reported topline results from the Phase 3 BRUIN CLL-322 trial evaluating Jaypirca, a non-covalent Bruton tyrosine kinase inhibitor, in combination with venetoclax and rituximab in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in progression-free survival versus venetoclax and rituximab alone, with results consistent across key subgroups, including patients previously treated with a covalent BTK inhibitor. Overall survival data were not yet mature but trended in favor of the combination regimen, while the safety profile remained consistent with known profiles, and discontinuation rates were low across both arms. Lilly plans to present detailed data at a medical conference and submit findings to regulators for potential label expansion later this year.

Eli Lilly (LLY) Says FDA Requests Additional Data on Obesity Pill

On April 9, 2026, Morgan Stanley raised its price target on Eli Lilly to $1,327 from $1,313 and maintained an Overweight rating, reflecting model updates across its biopharma coverage ahead of Q1 earnings.

Eli Lilly and Company (NYSE:LLY) develops and markets pharmaceutical products globally.

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