We are a clinical-stage biopharmaceutical company

advancing a portfolio of novel fatty acid synthase (FASN) inhibitors. FASN is a key regulator of the de novo lipogenesis pathway, which is overactive in acne and can cause elevated sebum and inflammation. FASN is also implicated in other diseases, including MASH and certain FASN-dependent tumor types.

Denifanstat

Our lead product candidate, denifanstat, is an oral, once-daily FASN inhibitor with a differentiated method of action with the potential to target multiple underserved diseases. Denifanstat is currently being evaluated in a U.S. Phase 3 registrational clinical trial for moderate to severe acne.

Development Pipeline: Indications and Clinical Milestones

Stage of Development

Therapeutic area

Indication

Preclinical

Phase 1

Phase 2

Phase 3

Dermatology

Denifanstat - First patient dosed in AURORA Phase 3 clinical trial in Oct 2026
TVB-3567
FASNi Topical*

Denifanstat (ASC40)

Metabolic
disease

Denifanstat Phase 3 ready (F2/F3MASH)
Denifanstat Ph1 hepatic impairment study complete
Denifanstat/resmetirom Ph 1 PK trial complete

Oncology

TVB-3567
Denifanstat

*FASN inhibitor Topical Formulation

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Denifanstat Update:

52-Week Data from Phase 3 Open-Label Extension in China and Planned AURORA Phase 3 Clinical Trial in US

Wednesday, September 30, 2026 | 1:00PM ET