NasdaqCM:MLTXBiotechs
Why MoonLake Immunotherapeutics (MLTX) Is Up 54.7% After FDA Opens Path to HS BLA Filing
MoonLake Immunotherapeutics recently reported that the U.S. FDA, following a Type B meeting, indicated its existing MIRA, VELA-1 and VELA-2 trial data for sonelokimab in hidradenitis suppurativa may be sufficient to support a Biologics License Application, which the company plans to submit in the second half of 2026.
An interesting aspect of the FDA feedback is that MoonLake may establish substantial evidence of effectiveness without running additional HS trials, potentially simplifying and...