Price Target Changed • Aug 14
Price target increased by 9.2% to US$28.60 Up from US$26.20, the current price target is an average from 10 analysts. New target price is 171% above last closing price of US$10.55. Stock is up 38% over the past year. The company is forecast to post a net loss per share of US$1.17 next year compared to a net loss per share of US$1.58 last year. Announcement • Aug 13
Sagimet Biosciences Receives FDA IND Clearance And Study May Proceed Letter For Phase 3 Trial Of Denifanstat In Moderate To Severe Acne Sagimet Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application and issued a 'Study May Proceed' letter for the company’s Phase 3 clinical trial of fatty acid synthase (FASN) inhibitor denifanstat in moderate to severe acne. The Phase 3 clinical trial is on track to initiate in the second half of 2026. The Phase 3 clinical trial is intended to enroll approximately 800 US patients, with 450 expected to be adolescents, using well-accepted co-primary endpoints that will be assessed at the end of the 12-week randomized double-blind period, followed by a 40-week open-label extension to evaluate long-term safety. The multi-center, randomized, double-blind, placebo-controlled Phase 3 clinical trial of denifanstat in moderate to severe acne is intended to enroll approximately 800 U.S. patients aged 12 years and older, of which 450 are expected to be adolescents aged 12 to 17 years. Patients will be randomized 2:1 to receive denifanstat 50 mg or placebo once daily for 12 weeks. The trial has three co-primary endpoints assessed at week 12: the proportion of patients achieving treatment success in a global assessment score, defined as at least a 2-point reduction from baseline with a score of 0 (clear) or 1 (almost clear); absolute change in inflammatory skin lesion counts from baseline; and absolute change in non-inflammatory skin lesion counts from baseline. Patients completing the double-blind period will be eligible to enter a 40-week open-label extension evaluating the long-term safety of denifanstat. Denifanstat is an oral, once-daily FASN inhibitor in development for the treatment of moderate to severe acne. In trials conducted by license partner, Ascletis BioScience Co. Ltd. (Ascletis) in China, Denifanstat met all primary and secondary endpoints in a 12 week randomized, double-blind Phase 3 clinical trial in moderate to severe acne vulgaris and was generally well-tolerated and showed improvements in all efficacy endpoints measured at 52 weeks (secondary endpoints of the trial) in an open-label Phase 3 clinical trial evaluating its long-term safety in patients with moderate to severe acne. Denifanstat is being developed by Ascletis as ASC40 for acne in China and by Sagimet in the rest of world. Recent Insider Transactions Derivative • Aug 12
Non-Executive Chairman notifies of intention to sell stock George Kemble intends to sell 20k shares in the next 90 days after lodging an Intent To Sell Form on the 11th of August. If the sale is conducted around the recent share price of US$9.57, it would amount to US$193k. George currently holds less than 1% of total shares outstanding. Company insiders have collectively sold US$684k more than they bought, via options and on-market transactions in the last 12 months.