Lanifibranor's Potential - Lanifibranor is presented as a potential best-in-disease oral therapy for MASH (Metabolic dysfunction-Associated SteatoHepatitis), targeting progressive fibrosis in F2/F3 MASH patients[1,5] - The company anticipates regulatory filings in 2027 and a potential commercial launch in 2028, pending approval[8] - Phase 2b trial data showed a 24% effect size on the dual endpoint of fibrosis improvement and MASH resolution in just 24 weeks[70] - The Phase 3 NATiV3 clinical trial is fully recruited with 1,009 patients in the main cohort and 410 in the exploratory cohort[56] - Topline data from the Phase 3 trial is expected in the second half of 2026[8,64] MASH Market and Medical Understanding - The MASH market is expected to exceed $15 billion by 2035[15] - Approximately 19 million were diagnosed with MASH in the U S in 2025, representing ~10% of the patients with MASH[13] - Approximately 910,000 patients have clinically actionable F2/F3 disease, with about 374,000 (~40%) under treated care[14] Financial Position - The company raised $172 million from investors in November 2025[8] - The company's cash runway extends until the middle of Q3 2027, assuming full exercise of the 3rd tranche[8,67]