Structure Therapeutics Inc. ADR (NASDAQ:GPCR) soared 28.8% in Monday’s premarket trading after releasing strong topline results from its ACCESS clinical program evaluating aleniglipron, an oral GLP-1 receptor agonist being developed for obesity.
In the Phase 2b ACCESS trial, the 120 mg dose produced a placebo-adjusted mean weight reduction of 11.3% (27.3 lbs) at 36 weeks. The exploratory ACCESS II study yielded even more striking data, with the 240 mg dose reaching placebo-adjusted mean weight loss of 15.3% (35.5 lbs) over the same period.
Notably, investigators found no sign of a weight-loss plateau at week 36, hinting that efficacy may continue to build with extended treatment. In the Phase 2b cohort, 86% of participants on 120 mg lost at least 5% of their body weight, and 70% achieved losses of 10% or more.
The company also highlighted improved tolerability when titration began at a 2.5 mg starting dose. In the ACCESS Open Label Extension and Body Composition Study, no treatment discontinuations due to adverse events were reported at this lower starting dose—compared with a 10.4% discontinuation rate in the Phase 2b study that initiated therapy at 5 mg.
Aleniglipron, a once-daily, orally administered small-molecule GLP-1 receptor agonist, could offer a convenient alternative to the injectable therapies currently leading the obesity market.
Structure Therapeutics said it plans to request a Type B End-of-Phase 2 meeting with the FDA in the first half of 2026 and expects to start Phase 3 development by mid-2026.