Sagimet posts 52-week denifanstat acne data

What happened

Sagimet Biosciences Inc. (NASDAQ: SGMT) said denifanstat produced a 57.8% treatment success rate after up to 52 weeks in patients with moderate to severe acne. The company said the Phase 3 open-label extension, ASC40-304, followed patients from the 12-week ASC40-303 trial in China. It said 240 patients entered the extension, including 116 who had started on denifanstat and 124 who had started on placebo.

The readout also showed 73.0% fewer total lesions, 78.1% fewer inflammatory lesions and 68.3% fewer non-inflammatory lesions in the denifanstat-only group. Sagimet said denifanstat was generally well-tolerated through 52 weeks, with no adverse event-related permanent discontinuations and no drug-related serious adverse events. It also said patient screening for AURORA is expected to begin in October 2026. Ascletis said the denifanstat NDA for moderate to severe acne was accepted by the China NMPA in December 2025.

Key numbers

Metric	Latest	Change	Source
Treatment success rate	57.8%		SEC 8-K Exhibit 99.2
Total lesion reduction	-73.0%		SEC 8-K Exhibit 99.2
Inflammatory lesion reduction	-78.1%		SEC 8-K Exhibit 99.2
Non-inflammatory lesion reduction	-68.3%		SEC 8-K Exhibit 99.2
Patients in ASC40-304	240 patients		SEC 8-K Exhibit 99.2

Read more: Sagimet Biosciences (SGMT) stock analysis and investment case

Why it matters

OptimistFi's case is that denifanstat still has to prove it can turn FASN inhibition into a differentiated MASH therapy before cash and dilution risk matter more. The acne update does not answer that main question. But it adds longer human exposure and shows the drug kept working through a year of treatment. That gives the company another clinical checkpoint before the U.S. trial.

Treatment success rose by 24.6 percentage points, from 33.2% in the 12-week randomized phase to 57.8% after up to 52 weeks in the denifanstat-only group. The same presentation said total lesions fell 73.0% and inflammatory lesions fell 78.1% in that group. The main caveat is that the 52-week data came from an open-label study run by Ascletis in China, so they support durability more than a U.S. approval case.

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What's next

Sagimet said patient screening for AURORA is expected to begin in October 2026. The trial is planned to enroll about 800 U.S. patients, including 450 adolescents aged 12 to 17 years. Patients will be randomized 2:1 to denifanstat 50 mg or placebo once daily for 12 weeks. A 40-week open-label extension is planned for about 530 patients, and the week 12 readout will test treatment success plus inflammatory and non-inflammatory lesion counts.

A clean result would strengthen the clinical package. Weaker efficacy or a delay would cut against it.

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