Sagimet Biosciences Inc. SGMT
Sagimet Biosciences Inc. (Nasdaq: SGMT) is a GI/hepatology drug developer. Its lead program, denifanstat (TVB-2640), is in Phase 2 for MASH (also acne and select cancers). Its next catalyst on record is TVB-3567: Sagimet plans to initiate TVB-3567 Phase 2 clinical trial in moderate to severe acne patients before the end of 2026. (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: TVB-3567 — Sagimet plans to initiate TVB-3567 Phase 2 clinical trial in moderate to severe acne patients before the end of 2026. (2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| denifanstat | MASH (Phase 2b FASCINATE-2 complete; further MASH development paused pending non-dilutive financing) | small molecule | Phase 2 |
| denifanstat + resmetirom | cirrhotic MASH (F4) | small molecule | Phase 1 |
| TVB-3567 | acne | small molecule | Phase 1 |
Recent results and decisions
- Oct 22, 2026positive Dosing for SAD/MAD and food effect parts complete for TVB-3567; drug was generally well tolerated and Phase 2 doses identified.
Dosing for SAD/MAD and food effect parts complete, TVB-3567 was generally well tolerated Phase 2 doses have been identified
Filing - started First patient dosed in AURORA Phase 3 clinical trial of denifanstat in the US for patients with moderate to severe acne in October 2026.
First patient dosed in AURORA Phase 3 clinical trial in the US for patients with moderate to severe acne in Oct 2026
Filing - Feb 2, 2026positive Licensee Ascletis' 240-patient open-label Phase 3 China trial showed denifanstat 50 mg generally well tolerated up to 52 weeks (dry eye 5.5%, dry skin 5.2%, no related Grade 3/4 AEs or SAEs) with efficacy improving beyond week 12.
Subjects treated with denifanstat showed improvements in all efficacy endpoints (secondary endpoints of the trial) beyond those observed at 12 weeks.
Filing
4 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 GI/hepatology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.