What is the expected timeline for FDA submission or approval based on these data?

Expected FDA timeline

The Lancet‑published Phase 2b HARMONY data are the first “late‑stage” read‑out for efruxifermin (EFX) in pre‑cirrhotic (F2‑F3) MASH, showing a clear antifibrotic signal after 96 weeks of treatment. In the drug‑development cycle, a positive Phase 2b read‑out typically paves the way for a pivotal Phase 3 program that is launched within the next 12‑18 months. Assuming Akero initiates a multicenter Phase 3 trial in the second half of 2025, the company would need to generate the primary efficacy read‑out (often 12‑18 months after the first patient is dosed) and compile the full data package by mid‑2026.

Given this schedule, the earliest FDA submission (e.g., a Type 2 NDA) would be expected in the second half of 2026, with a standard 12‑month review window. If the agency grants priority review—plausible given the unmet need in MASH and the strong fibrosis‑reduction signal—the review could be compressed to six months, pushing a potential approval date to early‑mid 2027.

Trading implication

The market will likely price in a “mid‑2026” filing window now; any news that accelerates the Phase 3 start (e.g., a fast‑track designation or a partnership with a big‑pharma partner) could push the submission timeline forward, creating upside pressure on AKRO shares. Conversely, delays in trial initiation or a lack of a priority‑review designation would keep the timeline anchored at the 2026‑2027 horizon and could cap upside until the filing window materialises. Positioning around the 2025‑2026 catalyst (Phase 3 start) with a view to capture the 2026‑2027 approval rally is therefore the most actionable approach.