MoonLake says FDA backs sonelokimab HS BLA plan, filing set for September 2026

MoonLake Immunotherapeutics Class A

MoonLake Immunotherapeutics Class A

MLTX

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  • MoonLake Immunotherapeutics reported a positive final pre-BLA meeting with FDA for sonelokimab in hidradenitis suppurativa, clearing remaining issues for a planned BLA filing at end-September 2026.
  • Regulator alignment supports a proposed label covering adults plus adolescents, with adolescent data set to be included from VELA-TEEN.
  • Key long-term updates will be presented in future readouts, including 52-week data from Phase 3 VELA-1 and VELA-2 in Q2 2026, with VELA-TEEN primary results expected mid-2026.
  • MoonLake expects BLA acceptance decision, including potential Priority Review, by end-November 2026, with first US launch targeted for second half of 2027 if approved.


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