Earnings summaries and quarterly performance for Sagimet Biosciences.
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Sagimet Biosciences Inc. Announces Global License Agreement with TAPI for Resmetirom API
SGMT
New Projects/Investments
- Sagimet Biosciences Inc. entered into a global, exclusive license agreement with TAPI for innovative forms of resmetirom active pharmaceutical ingredient (API) to support its fixed-dose combination (FDC) program.
- A Phase 1 pharmacokinetic (PK) trial of Sagimet's denifanstat and resmetirom combination is underway, with topline data anticipated by the end of 2025.
- Sagimet made a $2.5 million non-refundable up-front payment to TAPI, with potential for low single-digit royalties and up to $5.5 million in additional manufacturing-related milestones.
- The company plans to select one of the licensed resmetirom forms to manufacture a single FDC tablet for use in Phase 3 for MASH patients with cirrhosis.
Dec 17, 2025, 12:05 PM
Sagimet Biosciences Discusses Pipeline Progress and Funding Needs
SGMT
New Projects/Investments
Guidance Update
- Sagimet Biosciences is advancing its MASH program, focusing on a combination of Denifenstat with resmetirom for cirrhotic (F4) patients, with a Phase I study concluding and Phase II planned for next year. New intellectual property (IP) for this combination, filed in 2024, is expected to extend protection until 2044.
- The Denifenstat monotherapy program for F2/F3 MASH is Phase III ready and has Breakthrough Designation, but requires $400 million in funding to proceed, with $125 million currently available.
- In acne, Sagimet's partner Ascletis is seeking regulatory approval in China for Denifenstat, with expected approval in the first half of next year. Sagimet is also developing a next-gen molecule, TVB-3567, for acne, currently in Phase I and moving to Phase II by the end of next year.
- Sagimet anticipates receiving approximately $120 million in regulatory and commercial performance milestones from its acne partnership with Ascletis.
Dec 2, 2025, 5:55 PM
Sagimet Biosciences Provides Update on MASH and Acne Programs, Funding Needs
SGMT
New Projects/Investments
Guidance Update
Product Launch
- Sagimet Biosciences' lead molecule, Denifenstat, a potent FASN inhibitor, has demonstrated significant efficacy in MASH, particularly in advanced stages, with 11 of 13 qF4 patients showing a one or two stage improvement of fibrosis.
- The company is progressing a combination program of Denifenstat with resmetirom for cirrhotic (F4) MASH patients, with a Phase I study concluding and a Phase II expected in 2026. New IP for this combination, filed in 2024, could extend protection until 2044.
- While Denifenstat is Phase III ready for F2/F3 MASH and has received breakthrough designation, Sagimet requires $400 million to fund this study, against its current $125 million in cash.
- In acne, Sagimet's partner Ascletis anticipates regulatory approval in China in H1 2026 for Denifenstat, which could generate up to $120 million in milestones and royalties for Sagimet. Sagimet is also developing a next-gen molecule, TVB-3567, for the US market, with a Phase I study concluding next year and a Phase II planned by the end of 2026.
Dec 2, 2025, 5:55 PM
Sagimet Biosciences Reports Q3 2025 Financials and Clinical Program Updates
SGMT
Earnings
New Projects/Investments
- Sagimet Biosciences Inc. reported $125.5 million in cash, cash equivalents, and marketable securities as of September 30, 2025, which is expected to fund current operations for 2 years. The company also reported a net loss of $12.9 million for the quarter ended September 30, 2025.
- Ascletis, Sagimet's license partner for China, completed pre-New Drug Application (NDA) consultation with the China National Medical Products Administration (NMPA) for denifanstat for moderate-to-severe acne vulgaris and plans to submit an NDA soon.
- A Phase 1 pharmacokinetic (PK) trial evaluating a combination of denifanstat and resmetirom for MASH was initiated in September 2025, with topline data anticipated in the first half of 2026.
- A Phase 1 clinical trial for TVB-3567 for an acne indication was initiated in June 2025, with a Phase 2 trial in moderate to severe acne patients anticipated in 2026.
Nov 13, 2025, 12:36 PM
Sagimet Provides Update on Denifanstat Programs for MASH and Acne
SGMT
New Projects/Investments
Product Launch
- Sagimet (SGMT) is a clinical-stage biopharmaceutical company focused on developing denifanstat, a fatty acid synthase (FASN) inhibitor, for MASH and acne.
- In MASH, denifanstat demonstrated statistically significant reductions in fibrosis in a Phase IIb biopsy study, particularly in F3 stage patients, and is currently in a Phase I combination study with resmetirom for F4 stage patients, with results expected in H1 2026.
- For moderate to severe acne, Sagimet's partner Ascletis reported 20% reductions in lesion count and 18%-20% improvement in IGA score in Phase II and Phase III studies in China and is preparing to submit data for approval. Sagimet is also advancing a next-gen FASN inhibitor in a US Phase I study, with Phase II expected to start in H2 2026.
- The company highlights the favorable safety profile of denifanstat, having been evaluated in over 1,000 patients across multiple disease states, with gastrointestinal effects comparable to placebo.
- Sagimet anticipates the MASH market to triple or quadruple over the next decade or two and expects significant growth in the acne market with novel treatments.
Nov 10, 2025, 4:30 PM
Sagimet Biosciences Reports Positive Clinical Trial Results for Denifanstat in MASH and Acne
SGMT
New Projects/Investments
Product Launch
- Sagimet Biosciences' FASCINATE-2 Phase 2b clinical trial for denifanstat in MASH met primary and secondary endpoints, demonstrating statistically significant one and two-stage improvements in fibrosis, particularly in F3 MASH patients. Data also showed significant fibrosis improvement in 11 of 13 F4 MASH patients.
- A Phase 1 PK study combining denifanstat with resmetirom was initiated, with top-line results expected in the first half of next year (2026).
- Sagimet's partner, Kintor, reported statistically significant Phase 3 results for denifanstat in moderate to severe acne in China, meeting all primary and secondary endpoints, and plans to submit for approval. Sagimet also initiated a Phase 1 trial for its next-generation FASN inhibitor for acne in June.
Oct 21, 2025, 11:00 AM
Sedgemet Biosciences Provides Updates on Denifenstat Clinical Programs in NASH and Acne
SGMT
New Projects/Investments
Product Launch
- Sedgemet Biosciences' Denifenstat, a novel fatty acid synthase (FASN) inhibitor, demonstrated statistically significant improvements in fibrosis in the Phase 2b FAST-8 two study for NASH, particularly in F3 and F4 patients.
- The company initiated a Phase 1 PK study for a combination of Denifenstat and resmeteron for NASH, with top-line results anticipated in the first half of next year.
- In dermatology, Sedgemet's partner in China reported impressive statistically significant Phase 3 results for Denifenstat in moderate to severe acne, meeting all primary and secondary endpoints, and has received a green light for NMPA submission.
- Sedgemet also initiated a Phase 1 trial of its next-generation FASN inhibitor for acne in June.
Oct 21, 2025, 11:00 AM
Sagimet Bio Provides Clinical Development and Financial Update
SGMT
New Projects/Investments
Guidance Update
- Sagimet Bio, a clinical-stage biopharmaceutical company, is advancing its fatty acid synthase (FASN) inhibition programs for NASH and acne.
- In NASH, a Phase I PK study of its lead molecule, denifanstat, combined with resmetirom in F4 cirrhotic patients is starting, with data anticipated by the end of 2025 or early 2026. The company holds IP on this combination until 2044.
- For acne, Sagimet's partner Ascletis reported positive Phase III results for denifanstat in China, showing statistically significant results across all primary and secondary endpoints and a good safety profile. Sagimet is progressing its next-generation molecule, 3,567, into a Phase I study, with completion expected by early 2026 and a Phase II program planned for the first half of 2026. The IP for 3,567 extends to 2046.
- Sagimet has approximately $135 million in cash, providing a financial runway until 2028, which is expected to cover the Phase IIb biopsy study for NASH and the continued development of 3,567 in acne.
Sep 3, 2025, 6:48 PM
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