MoonLake aligns with FDA on BLA for sonelokimab in HS; Q1 cash $357.9M

MoonLake Immunotherapeutics

FDA pre-BLA meeting positive; alignment on submission plans, adolescent data inclusion, and safety strategy.
BLA submission planned for end of Sep 2026; Priority Review decision expected within 60 days.
Proposed label includes ~43% HiSCR75 response and ~29pp delta-to-placebo from MIRA trial, highest in HS.
Cash $357.9M as of Mar 31, 2026; runway to end of 2027; up to $400M non-dilutive debt facility available.
R&D expenses $54.5M (stable); G&A $15.5M with $4.8M accelerated stock option cancellation.

item 2.02 item 7.01 item 9.01

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Earnings Releases SEC 8-K Item 2.02 confidence 0.9

MoonLake Immunotherapeutics reported financial results for first quarter of 2026.

Period: first quarter of 2026
Result: reported results

Exact text from the filing

Today, MoonLake also reported its financial results for the first quarter of 2026.

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Source: SEC EDGAR

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