Sagimet Biosciences

The FDA has approved the Investigational New Drug (IND) application for Sagimet Biosciences, enabling the company to start a planned phase-3 study of the fatty acid synthase inhibitor Denifanstat in moderate-to-severe acne. The company gave no details on timing, study design or participant numbers. At the same time, Sagimet was added to the Russell 2000 and Russell 3000 indices, while Citizens cut its price target from $35.00 to $12.00 but kept its rating at "Market Outperform." » More on de.investing.com

Sagimet Biosciences shares rose in pre-market trading after Q2 numbers and a clinical update. The company reported a net loss of $14.0 million for the quarter, slightly better than consensus, and reaffirmed its focus on Denifanstat. Partner Ascletis presented phase-3 data that showed roughly a 20 percentage-point higher success rate versus placebo in acne and reported no serious adverse events. Sagimet plans a U.S. registration-enabling phase-3 study with 800 patients (including 450 adolescents) starting in H2 2026; analysts on average give a “Strong Buy” rating and a 12-month price target of $28.50. » More on de.investing.com

Sagimet is refocusing its strategy on acne and will start a U.S. phase‑III trial for Denifanstat in the coming months, supported by strong phase‑III results from partner Ascletis in China that showed roughly a 20‑percentage‑point higher IGA success rate versus placebo and reported a favorable safety profile. The planned randomized study will include 800 patients (including 450 adolescents) with IGA, inflammatory and non‑inflammatory lesions as primary endpoints; first dosing is imminent and topline data are expected shortly after treatment completion next year. Sagimet sees a large, underserved market opportunity, anticipates a potential premium price floor of $1,200–1,500/month, and is advancing a second oral FASN program as well as a topical program in parallel. » More on de.investing.com