Sagimet Biosciences Inc. Stock Price, News & Analysis

Sagimet Biosciences (NASDAQ: SGMT) reported positive Phase 1 pharmacokinetic (PK) results for a once-daily combination of denifanstat and resmetirom on Dec 18, 2025. The open-label, 2-cohort PK study (NCT07216313) enrolled 40 healthy adults to evaluate multiple- and single-dose PK, drug-drug interactions, safety, and tolerability. The combination was generally well-tolerated with no serious adverse events, no treatment discontinuations, and no clinically significant lab abnormalities. Sagimet plans to use these data to pursue a Phase 2 proof-of-concept efficacy trial in MASH with F4 fibrosis, aiming to initiate the study in 2H 2026, subject to regulatory consultation, and noted a global license agreement for resmetirom API forms to support a fixed-dose combination development.

Sagimet Biosciences (Nasdaq: SGMT) entered a global, exclusive license with TAPI for innovative forms of the resmetirom API to support Sagimet’s fixed‑dose combination (FDC) program combining resmetirom with denifanstat.

The company has an ongoing Phase 1 pharmacokinetic trial of the denifanstat‑resmetirom combination (first participants dosed in September 2025) with topline data anticipated by end of 2025. Sagimet expects to select one licensed resmetirom form for manufacture of a once‑daily FDC tablet and plans to use that FDC in a Phase 3 study; a Phase 2 in F4 MASH is estimated to start in H2 2026, subject to regulatory consultation.

Sagimet (Nasdaq: SGMT) announced that Ascletis’ parent company said China’s National Medical Products Administration accepted a New Drug Application (NDA) for denifanstat (ASC40) for the treatment of moderate to severe acne on Dec 10, 2025. Sagimet granted Ascletis an exclusive license for denifanstat in China while Sagimet retains development rights for MASH in the rest of world. The NDA filing reflects Ascletis’ Phase 3 trial in acne, in which denifanstat met all primary and secondary endpoints and was generally well tolerated.

Ascletis (HKEX:1672) announced on December 10, 2025 that the China National Medical Products Administration (NMPA) accepted its New Drug Application for denifanstat (ASC40), a once-daily oral FASN inhibitor for moderate-to-severe acne vulgaris.

The company said denifanstat completed Phase II (NCT05104125) and Phase III (NCT06192264) studies, and in Phase III met all primary, key secondary and secondary efficacy endpoints (ITT analysis) versus placebo with a favorable safety profile and no related Grade 3/4 adverse events or related serious adverse events. The Phase III results were presented at EADV on September 17, 2025. Ascletis holds exclusive Greater China rights under a license from Sagimet Biosciences (Nasdaq: SGMT).

Sagimet Biosciences (Nasdaq: SGMT) announced inducement option grants on December 9, 2025 in connection with hiring three new employees. The Compensation Committee approved an aggregate of 42,800 stock options under the Nasdaq Rule 5635(c)(4) inducement exception, to be granted on December 9, 2025.

The options use a Black‑Scholes‑determined grant value and have an exercise price equal to the closing price on December 9, 2025 as reported by the Nasdaq Global Market. Each option has a 10‑year term and vests over four years: 25% at the one‑year anniversary and the remainder monthly over 36 months, subject to continued service.

Sagimet Biosciences (Nasdaq: SGMT) will participate in the 8th Annual Evercore ISI Healthcare Conference on Tuesday, December 2, 2025 in Coral Gables, Florida.

Management will take part in a fireside chat at 12:55pm ET. A live webcast will be available in the company’s Investors & Media section at www.sagimet.com, with an archived replay accessible for 90 days after the event.

Sagimet Biosciences (Nasdaq: SGMT) reported Q3 2025 corporate updates and financials on November 13, 2025. Key clinical milestones include an ongoing Phase 1 PK trial of a once-daily combination of denifanstat and resmetirom (≈40 healthy adults) with topline data expected in 1H 2026, and an ongoing first-in-human Phase 1 trial of FASN inhibitor TVB-3567 for acne. Partner Ascletis completed a pre-NDA consultation with China’s NMPA and plans an NDA submission for denifanstat for moderate-to-severe acne after a 480-patient Phase 3 trial that met all efficacy endpoints. Financials: $125.5M cash and marketable securities; nine-month net loss $41.5M.

Sagimet Biosciences (Nasdaq: SGMT) presented two posters at AASLD The Liver Meeting® 2025 on November 7-11, 2025 reporting secondary analyses of the Phase 2b FASCINATE-2 trial for denifanstat.

Key findings: in AI-defined qFibrosis stage 4 (qF4) patients, denifanstat showed ≥1 qFibrosis stage regression in 85% (11/13) vs 33% (1/3) for placebo; in CRN-scored F3 patients, ≥2-stage fibrosis improvement was 34% (16/47) vs 4% (1/23) placebo (p=0.0065). Multiple noninvasive biomarkers fell substantially vs placebo at week 52 (FibroScan -29% vs +26%, FAST -45% vs +9%, MRI-PDFF -34% vs +14%, ALT -43%, AST -37%).

Sagimet (Nasdaq: SGMT) reported that denifanstat, a once-daily oral 50 mg FASN inhibitor, met all primary and secondary endpoints versus placebo in a Phase 3 randomized, double-blind, placebo-controlled trial in China enrolling 480 patients with moderate-to-severe acne (IGA 3–4) treated for 12 weeks. At Week 12, treatment success rates were more than double placebo with marked reductions in inflammatory and non-inflammatory lesions. Denifanstat was generally well tolerated. Ascletis completed a pre-NDA consultation with China NMPA and plans to submit an NDA soon. Trial data will be presented at the 2025 Fall Clinical Dermatology Conference (Oct 24–26) in Las Vegas.