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Sagimet Biosciences AURORA Trial to Start Enrollment in Q4
Sagimet Biosciences announced that its AURORA Phase 3 clinical trial of FASN inhibitor denifanstat in moderate to severe acne is on track to initiate enrollment in Q4.
Sagimet CEO Announces Denifanstat to Enter Phase 3 Clinical Trial in 2026
"The second quarter saw Sagimet building on our strategic decision to focus on dermatology. Denifanstat, if approved, could offer a convenient oral once-daily treatment option for patients aged 12 years and older living with moderate to severe acne, and would be the first innovative oral treatment approved for acne in more than forty years," said David Happel, Chief Executive Officer of Sagimet. "We plan to advance denifanstat into a registrational Phase 3 clinical trial in moderate to severe acne in the United States in the second half of 2026. With our recent equity financing, we are well positioned to fund our programs through 2028, including through data readout of the Phase 3 denifanstat trial and NDA submission."
Sagimet Plans to Initiate Phase 3 Acne Trial in H2 2026
"Our recent strategic decision to focus on dermatology marks a turning point for Sagimet, and we are excited about the path ahead. In the near term, we are targeting the second half of 2026 to initiate a Phase 3 clinical trial of denifanstat in moderate to severe acne in the U.S. We believe that denifanstat, with its differentiated mode of action, could potentially offer a convenient oral once-daily treatment option for those living with moderate to severe acne. The clinical community caring for patients with acne has waited more than 40 years for an innovative oral treatment," said David Happel, Chief Executive Officer of Sagimet. "We recently strengthened Sagimet's ability to move forward with its innovative dermatology programs with the completion of a $175 million equity financing. Combined with our existing cash balance, we are well capitalized to fund our programs through 2028 including data readout of our planned denifanstat Phase 3 clinical trial in moderate to severe acne."
Sagimet Biosciences Appoints Andreas Grauer as Chief Medical Officer
Sagimet Biosciences (SGMT) announced the appointment of Andreas Grauer, MD, as Chief Medical Officer, effective April 20, 2026. Sagimet's prior Chief Medical Officer, Eduardo Bruno Martins, MD, DPhil, who will continue to support the Company as an external scientific advisor, has retired effective April 20, 2026. Grauer most recently served as Chief Medical Officer at Omeros Corporation (OMER)
Sagimet CEO: Advancements in MASH and Acne Programs in 2025
"2025 saw important advances in both our MASH and acne programs," said David Happel, Chief Executive Officer of Sagimet. "We completed our Phase 1 PK clinical trial of denifanstat and resmetirom combination and anticipate advancing the combination into a proof-of-concept Phase 2 clinical trial in F4 MASH, for which there are currently no approved treatments, in the second half of the year. In acne, positive 52-week data from our license partner Ascletis' Phase 3 open-label acne trial with denifanstat will support Ascletis' NDA that was accepted by the Chinese NMPA. We anticipate further exploring the potential role of FASN inhibition in acne in clinical development in 2026."
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