Sagimet Advances Denifanstat Toward Phase 3 Acne Trial Enrollment

Sagimet Biosciences (SGMT) said it received an FDA “Study May Proceed” letter and IND clearance to start a pivotal Phase 3 trial of oral drug Denifanstat for moderate to severe acne in adolescents and adults. The randomized, double-blind, placebo-controlled study (about 800 patients) is expected to begin in 2H 2026, with 12-week treatment plus 40-week extension.

Sagimet Biosciences (Nasdaq: SGMT) said the FDA cleared its IND and issued a “Study May Proceed” letter for denifanstat, a Phase 3 FASN inhibitor for moderate to severe acne. The trial is planned to start in 2H 2026, enrolling about 800 U.S. patients (450 adolescents). Dosing is 50 mg once daily vs placebo for 12 weeks, with a 40-week open-label extension.

Sagimet Biosciences (SGMT) shares rose 3.4% pre-open to $9.84 after Q2 2026 results. The company reported a net loss of $14.0 million for the quarter ended June 30, slightly better than consensus, and reaffirmed its denifanstat pipeline. It cited Phase 3 data from Ascletis in China showing about a 20-point improvement vs placebo, with no serious adverse events, and plans a U.S. Phase 3 trial enrolling 800 patients starting H2 2026. Analysts rate it Strong Buy with a $28.50 average 12-month targe

Sagimet Biosciences (Nasdaq: SGMT) reported Q2 2026 results and updates. It plans to initiate a U.S. registrational Phase 3 for denifanstat in moderate to severe acne in 2H 2026. First-in-human Phase 1 for FASN inhibitor TVB-3567 is ongoing. In April 2026 it raised $175.0M gross. Cash and marketable securities were $257.6M at June 30, 2026, funding operations through 2028.

Sagimet Biosciences Inc. (SGMT) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Sagimet Biosciences Reports Second Quarter 2026 Financial Results and Provides Corporate Updates Phase 3 clinical trial of denifanstat in moderate to severe acne patients for the U.S. on track to initiate in second half of 2026 First-in-human Phase 1 clinical trial o

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