MoonLake revives FDA push; biotech trio to debut in Hong Kong
MoonLake Immunotherapeutics received positive FDA feedback following a Type B meeting on its HS program for Sonelokimab (SLK). The FDA indicated MoonLake may establish substantial evidence of effectiveness for HS without conducting additional clinical trials.134
The FDA agreed that data from the MIRA, VELA‑1, and VELA‑2 trials together can support the Biologics License Application (BLA) for Sonelokimab in Hidradenitis Suppurativa.134
MoonLake plans to submit a BLA for Sonelokimab in HS in the second half of 2026, continuing preparations on the original timeline.123
The FDA specifically advised including MIRA results in the BLA to help establish effectiveness and using VELA‑2 results to inform the safety profile of Sonelokimab.13
Across MIRA and VELA, more than 1,000 patients with moderate‑to‑severe HS were enrolled, providing a substantial late‑stage data package for the planned HS submission.134
MoonLake’s MIRA trial was the first placebo‑controlled randomized clinical trial in HS using HiSCR75 as the primary endpoint, showing a 43% response with 120 mg Sonelokimab and a 29‑percentage‑point difference versus placebo at week 12.1
MoonLake will hold an Investor Day on February 23, 2026 to discuss the FDA feedback, the HS BLA strategy, and new clinical data across indications.123
Additional key 2026 milestones for Sonelokimab include Phase 3 readouts in axial spondyloarthritis (Q1 2026) and psoriatic arthritis (mid‑2026), alongside other late‑stage trials.12
MoonLake recently announced a $75 million share offering on Nasdaq, selling over 7.1 million Class A shares at $10.50 each, to support its development and commercialization plans.1
Separate from MoonLake, financial press has reported that a trio of biotech companies is preparing to list in Hong Kong, signaling renewed activity in the city’s biotech IPO market; detailed names and deal terms were not included in the cited MoonLake‑focused sources and would require additional capital‑markets reporting beyond these documents.
Sources:
1. https://www.investing.com/news/company-news/fda-confirms-moonlakes-path-to-hs-drug-approval-without-additional-trials-93CH-4437082
2. https://marketchameleon.com/articles/b/2026/1/8/fda-feedback-clears-path-for-moonlake-sonelokimab-no-extra-hs-trials
3. https://www.globenewswire.com/news-release/2026/01/08/3215344/0/en/MoonLake-Immunotherapeutics-Announces-Positive-Outcome-from-Type-B-Meeting-with-U-S-FDA-and-Announces-Investor-Day.html
4. https://www.dermatologytimes.com/view/fda-feedback-supports-bla-pathway-for-sonelokimab-in-hs