MoonLake Completes FDA Pre-BLA, BLA Sep 2026

MoonLake Immunotherapeutics held its final FDA pre‑BLA meeting on April 1, securing acceptance of MIRA trial data and inclusion of VELA‑TEEN data.
Label cites ~43% HiSCR75 response and ~29‑point placebo delta at week 12; BLA filing slated for end‑Sept 2026 with Priority Review intent.
MoonLake reported $357.9 million cash and a $400 million debt facility, expecting sufficient capital through 2027 despite $196 million negative levered free cash flow YTD.
Analysts upgraded MoonLake, with price targets ranging $24‑$40, reflecting optimism from regulatory clarity and positive 40‑week trial data.