MoonLake makes positive progress in FDA meeting, stock price rises 4%

Switzerland Zug — On Monday, MoonLake Immunotherapeutics (Nasdaq: MLTX) reported first-quarter results. The company recorded a loss of $0.98 per share, worse than analysts’ expected loss of $0.89 per share.

After the news was released, the company’s stock surged 4.28% in pre-market trading.

The biotech company announced that it completed the final BLA pre-application meeting with the U.S. Food and Drug Administration (FDA) on April 1, during which the two sides agreed on the submission plan for sonelokimab for hidradenitis suppurativa.

The FDA confirmed acceptance of the MIRA trial data and agreed to include the VELA-TEEN adolescent trial data in the drug label, enabling MoonLake to apply for a label for patients aged 12 and older.

The proposed label is expected to include an approximately 43% HiSCR75 response rate from the MIRA trial, and a difference of about 29 percentage points versus placebo at Week 12. MoonLake plans to submit the BLA application by the end of September 2026, with expected acceptance by the end of November 2026.

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The company said: “All BLA pre-application processes for hidradenitis suppurativa have been completed without any outstanding issues.” If approved by the FDA, the company expects to achieve its first commercial launch in the United States in the second half of 2027.

As of the end of this quarter, MoonLake held a total of $357.9 million in cash, cash equivalents, and short-term tradable debt securities.

For the three months ended March 31, 2026, research and development expenses were $54.5 million, down from $56.0 million in the prior quarter.

General and administrative expenses increased from $9.2 million to $15.5 million, mainly due to $4.8 million in accelerated expense recognition resulting from the voluntary cancellation of unvested stock option awards.

The company expects its existing capital to support operations through the end of 2027, and it can also obtain up to $400 million in additional non-dilutive funding through a debt financing agreement with Hercules Capital.

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