Sagimet Biosciences

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.

Ascletis Pharma Inc. completes enrollment of 480 patients for Phase III trial of ASC40 (denifanstat) for moderate to severe acne, with topline results expected in Q2 2025.

Ascletis Pharma completes enrollment of 480 patients for Phase III trial of ASC40 oral tablet for moderate to severe acne, with topline results expected in Q2 2025.

Sagimet Biosciences plans two Phase 3 trials, FASCINATE-3 and FASCINIT, to evaluate denifanstat's safety and efficacy in MASH and MASLD patients, with initiation expected by end of 2024.

UAVS up 70% pre-market on $6.5M public offering, SLXN up 50% on SIL-204 preclinical breakthroughs, SGMT up 11% on FDA Breakthrough Therapy Designation for Denifanstat in MASH.