# MoonLake Immunotherapeutics Announces Positive Outcome from Type B Meeting with U.S. FDA and Announces Investor Day
Canonical URL: https://biopharmsignal.com/news/MLTX/moonlake-immunotherapeutics-announces-positive-outcome-from-type-b-meeting-with-u-s-fda-and-announces-investor-day
Ticker: MLTX
Company: MoonLake Immunotherapeutics
Source: MoonLake Immunotherapeutics
Published: 2026-01-08 13:00 EST
Original Source URL: https://ir.moonlaketx.com
## Summary

MoonLake requested a Type B meeting with the U.S. Food and Drug Administration (FDA) to obtain regulatory clarity and discuss the clinical evidence strategy for submission of a Biologic License Application (BLA) for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS) FDA feedback confirms that the

## Article Body
MoonLake requested a Type B meeting with the U.S. Food and Drug Administration (FDA) to obtain regulatory clarity and discuss the clinical evidence strategy for submission of a Biologic License Application (BLA) for Sonelokimab (SLK) in Hidradenitis Suppurativa (HS) FDA feedback confirms that the
## Recent Company News
- 2026-05-10 13:00 EST — [MoonLake Immunotherapeutics Announces Positive Outcome from its Final Pre-BLA Meeting with the U.S. FDA and Reports First Quarter 2026 Financial Results](https://biopharmsignal.com/news/MLTX/moonlake-immunotherapeutics-announces-positive-outcome-from-its-final-pre-bla-meeting-with-the-u-s-fda-and-reports-first-quarter-2026-financial-results) — Source: MoonLake Immunotherapeutics
- 2026-03-28 19:00 EST — [MoonLake announces Week 40 Results from its Phase 3 Clinical Trials of Sonelokimab in Hidradenitis Suppurativa at the 2026 AAD Annual Meeting](https://biopharmsignal.com/news/MLTX/moonlake-announces-week-40-results-from-its-phase-3-clinical-trials-of-sonelokimab-in-hidradenitis-suppurativa-at-the-2026-aad-annual-meeting) — Source: MoonLake Immunotherapeutics
- 2026-02-22 16:00 EST — [MoonLake Announces Positive Topline Results from its Phase 2 Clinical Trial of Sonelokimab in Axial Spondyloarthritis and Reports 2025 Financial Results](https://biopharmsignal.com/news/MLTX/moonlake-announces-positive-topline-results-from-its-phase-2-clinical-trial-of-sonelokimab-in-axial-spondyloarthritis-and-reports-2025-financial-results) — Source: MoonLake Immunotherapeutics
- 2026-02-02 13:00 EST — [MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on Upcoming Investor Day](https://biopharmsignal.com/news/MLTX/moonlake-announces-fda-fast-track-designation-for-sonelokimab-palmoplantar-pustulosis-ppp-and-provides-details-on-upcoming-investor-day) — Source: MoonLake Immunotherapeutics
- 2026-01-08 13:00 EST — [MoonLake Immunotherapeutics Announces Positive Outcome from Type B Meeting with U.S. FDA and Announces Investor Day](https://biopharmsignal.com/news/MLTX/moonlake-immunotherapeutics-announces-positive-outcome-from-type-b-meeting-with-u-s-fda-and-announces-investor-day) — Source: MoonLake Immunotherapeutics
## Related News
- 2026-07-29 13:00 EST — ENLV — [Enlivex Management to Host Webinar to Discuss Capital Strategy, Rain Protocol Treasury Strategy, and Recent Clinical Milestones](https://biopharmsignal.com/news/ENLV/enlivex-management-to-host-webinar-to-discuss-capital-strategy-rain-protocol-tre-5921a627)
- 2026-07-29 12:30 EST — PRGO — [Perrigo to Present at the Canaccord 46th Annual Growth Conference](https://biopharmsignal.com/news/PRGO/perrigo-to-present-at-the-canaccord-46th-annual-growth-conference-40431922)
- 2026-07-29 12:30 EST — LIXT — [NOMAD Announces Operational Deployment of Two Mobile Battery Systems by DSO Electric Cooperative](https://biopharmsignal.com/news/LIXT/nomad-announces-operational-deployment-of-two-mobile-battery-systems-by-dso-elec-7fc12a2c)
- 2026-07-29 12:30 EST — RNXT — [RenovoRx to Host Second Quarter 2026 Financial Results and Business Highlights Conference Call on August 12th at 4:30 p.m. ET](https://biopharmsignal.com/news/RNXT/renovorx-to-host-second-quarter-2026-financial-results-and-business-highlights-c-8bed10ec)
- 2026-07-29 12:25 EST — ICCM — [IceCure: SIO Petitions NCCN to Include Cryoablation in Breast Cancer Treatment Guidelines, Citing IceCure's FDA Clearance  of ProSense®](https://biopharmsignal.com/news/ICCM/icecure-sio-petitions-nccn-to-include-cryoablation-in-breast-cancer-treatment-gu-bec46cd3)
