This is acceptable, MoonLake (NASDAQ:MLTX) gets positive FDA meeting for drug approval

ZUG, Switzerland – On Monday, MoonLake Immunotherapeutics (NASDAQ: MLTX) reported a first-quarter loss of -$0.98 per share, missing analyst estimates of -$0.89.

The company’s shares surged 4.28% in pre-market trading after the results.

The biotechnology company announced it completed its final pre-BLA meeting with the FDA on April 1, with alignment reached on submission plans for sonelokimab in hidradenitis suppurativa.

The FDA confirmed acceptability of MIRA trial data and agreed to include VELA-TEEN adolescent trial data in the label, allowing MoonLake to propose a label for patients aged 12 years and above.

The proposed label is expected to include the MIRA trial’s approximately 43% HiSCR75 response rate and approximately 29 percentage point delta-to-placebo at week 12. MoonLake plans to submit its BLA at the end of September 2026, with acceptance expected by the end of November 2026.

“With no remaining gaps identified, the pre-BLA process for HS is complete,” the company stated. Subject to FDA approval, the first commercial launch in the United States is expected in the second half of 2027.