Sagimet Biosciences

At the Cantor conference Sagimet presented data from China showing placebo‑adjusted improvements of about 20% on the Investigator Global Assessment and a 20% reduction in lesion count. The FDA has accepted a single phase‑III study (AURORA) of around 800 patients, including 450 adolescents; screening is planned to begin in October 2024, with primary data expected in 2025. Management sees a large U.S. market opportunity (10–15 million patients with moderate to severe acne) and plans premium pricing and direct marketing strategies, but warns of risks in replicating the China data, reimbursement, and commercialization. Sagimet expects patent protection and potential market exclusivity through November 2037 and raised funds in April 2024 to finance its dermatology programs. » More on de.investing.com

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