Denifanstat

Sagimet Biosciences Inc. announced an oral presentation on FASN inhibitors, focusing on denifanstat's mechanism and anti-fibrotic effects in Phase 2b FASCINATE-2 study, at MASH-TAG 2025. Denifanstat, targeting MASH, has FDA Breakthrough Therapy designation and is advancing to Phase 3.

MASH, a complex liver disease, lacks adequate diagnostics, complicating clinical trials. Rezdiffra, the first approved therapy not requiring liver biopsy, marks progress. Experts advocate for combination therapies and non-invasive diagnostic advancements to overcome trial design challenges and improve patient outcomes.

Sagimet Biosciences' stock surged 30% due to clinical successes, regulatory endorsements, and positive analyst sentiment. Their lead candidate, Denifanstat, received FDA Breakthrough Therapy designation for MASH, showing potential to improve liver health metrics and fibrosis. The company faces challenges like funding for Phase 3 trials and limited market capitalization.

Sagimet's denifanstat shows promise in treating F2/F3 MASH, with Phase 3 trials planned. Also explored for acne and glioblastoma, with positive Phase 2 results. Analysts see strong potential, rating SGMT a Strong Buy. Y-mAbs focuses on oncology, with DANYELZA approved and SADA platform advancing, also rated Strong Buy.

TD Cowen analyst Ritu Baral initiates Buy rating on Sagimet Biosciences, Inc. (SGMT) due to strategic advancements, including two Phase 3 trials (FASCINATE-3 and FASCINIT) for non-cirrhotic MASH treatment, and strong financial position with $170 million in cash. UBS also initiates Buy rating with $12.00 price target.

Sagimet Biosciences reports financial results for Q3 2024, highlighting the FDA's Breakthrough Therapy designation for denifanstat in MASH and the successful completion of end-of-Phase 2 interactions, paving the way for a Phase 3 program expected by end of 2024. The company anticipates a cash runway through 2025 with $170.0 million in cash, cash equivalents, and marketable securities as of September 30, 2024.

Sagimet Biosciences Inc. reports no license revenue, a $(16.9) million loss from operations, and a $(14.6) million net loss in its latest Form 10-Q. The company is advancing denifanstat, a FASN inhibitor, into Phase 3 trials for MASH, with FDA Breakthrough Therapy designation. Sagimet plans to initiate two Phase 3 trials by end of 2024 and expand its pipeline into acne and cancer. The company faces operational, liquidity, and regulatory risks, relying on external funding and third-party vendors.