Shares of Eli Lilly (LLY) jumped on Thursday morning after the company announced topline Phase 3 results from ACHIEVE-1, evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Commenting on the news, Leerink said that the once-daily oral GLP-1 pill showed similar efficacy and safety relative to weekly injectable semaglutide, made by Novo Nordisk (NVO).

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PRIMARY ENDPOINT MET: Eli Lilly announced topline Phase 3 results from ACHIEVE-1, evaluating the safety and efficacy of orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone. Orforglipron is the first oral small molecule glucagon-like peptide-1 receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial. If approved, the company is confident in its ability to launch orforglipron worldwide without supply constraints. This would further Lilly’s mission to reduce chronic diseases like type 2 diabetes, which is expected to impact an estimated 760 million adults by 2050.

In the first Phase 3 trial of the ACHIEVE program, orforglipron met the primary endpoint of superior A1C reduction compared to placebo at 40 weeks, lowering A1C by an average of 1.3% to 1.6% from a baseline of 8%, using the efficacy estimand. In a key secondary endpoint, more than 65% of participants taking the highest dose of orforglipron achieved an A1C less than or equal to 6.5%, which is below the American Diabetes Association’s defined threshold for diabetes. In an additional key secondary endpoint, participants taking orforglipron lost an average of 16.0 lbs at the highest dose. Given that participants had not yet reached a weight plateau at the time the study ended, it appears that full weight reduction was not yet attained.

The overall safety profile of orforglipron in ACHIEVE-1 was consistent with the established GLP-1 class. Overall treatment discontinuation rates due to adverse events were 6%, 4% and 8% for orforglipron vs. 1% with placebo. No hepatic safety signal was observed. Lilly expects to submit orforglipron for weight management to global regulatory agencies by the end of this year, with the submission for the treatment of type 2 diabetes anticipated in 2026.

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PICTURE-PERFECT: Calling the results “picture-perfect,” Leerink notes Eli once-daily oral GLP-1 pill showed similar efficacy and safety relative to weekly injectable semaglutide, made by Novo Nordisk. Importantly, the press release stated that “no hepatic safety signal was observed.” The firm expects the next orforglipron Phase 3 topline result in Q3 2025, and it expects orforglipron to be approved in 2026. Leerink reiterates an Outperform rating on Eli Lilly’s shares.

HIGHLY COMPETITIVE: JPMorgan says Eli Lilly released Phase 3 data for orforglipron in type 2 diabetes today, and overall the results suggest a “highly competitive profile” for the drug. Orforglipron was highly efficacious on HbA1c, but weight loss was the primary focus for investors and here orforglipron showed a 6.3% placebo adjusted reduction from baseline at its highest dose, which is largely comparable to Wegovy and in line with Street expectations for 5%-6% weight loss, the firm tells investors in a research note. JPMorgan adds that tolerability looks manageable with only an 8% discontinuation rate on the high dose. JPMorgan has an Overweight rating on Eli Lilly shares.

HIGHLY FAVORABLE FOR STRUCTURE: In a separate note, JPMorgan says Eli Lilly’s Phase 3 data for orforglipron in type 2 diabetes suggest a “highly competitive profile” for the drug. The firm views the data as its base case scenario, whereby Structure Therapeutics (GPCR) shares could be up double-digit percent in this scenario on a “highly favorable read-through” and Viking Therapeutics (VKTX) could move mid-single-digit in either direction. JPMorgan’s focus was primarily on orfoglipron’s tolerability profile with the extended titration, and here the data is highlighted by an 8% discontinuation rate on the highest dose versus low-teens expectations.

The firm sees the data as “helping derisk the category,” giving more confidence that Structure can also bring tolerability of aleniglipron to reasonable levels. For Viking, the read-through is not as direct, and today’s data “clearly helps derisk a strong” first in class oral competitor from Lilly, which could limit the potential of late entrant injectable assets, says JPMorgan. However, the firm believes the data “still leaves a clear role” for Viking’s “highly tolerable” oral VK-2735.

PRICE ACTION: In morning trading, shares of Eli Lilly have climbed over 13% to $832.05, while Structure Therapeutics moved 10% higher to $20.37. Trading lower following the news, Viking Therapeutics has dropped more than 3% to $22.81.

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JPMorgan says Lilly data ‘highly favorable’ for Structure Therapeutics Eli Lilly rises 16.3% Early notable gainers among liquid option names on April 17th Eli Lilly rises 13.0% Unusually active option classes on open April 17th

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