MoonLake Immunotherapeutics (NASDAQ:MLTX) shares rose more than 4% in premarket trading on Monday after the biotechnology company announced positive progress in discussions with the U.S. Food and Drug Administration regarding its planned biologics license application for sonelokimab.
The company also reported a first-quarter loss of $0.98 per share, slightly wider than analyst expectations for a loss of $0.89 per share.
FDA Aligns With Company on Submission Strategy
MoonLake said it completed its final pre-BLA meeting with the FDA on April 1, reaching agreement on plans for the submission of sonelokimab for the treatment of hidradenitis suppurativa.
According to the company, the FDA confirmed the acceptability of data from the MIRA trial and also agreed to include results from the VELA-TEEN adolescent study in the proposed product label.
This would allow MoonLake to seek approval for patients aged 12 years and older.
The proposed label is expected to feature the MIRA trial’s approximately 43% HiSCR75 response rate as well as an approximately 29 percentage point improvement over placebo at week 12.
MoonLake said it plans to submit its biologics license application by the end of September 2026, with formal acceptance anticipated before the end of November.
“With no remaining gaps identified, the pre-BLA process for HS is complete,” the company stated.
Subject to regulatory approval, MoonLake expects a first commercial launch in the United States during the second half of 2027.
Cash Position Supports Development Plans
At the end of the quarter, MoonLake held $357.9 million in cash, cash equivalents and short-term marketable debt securities.
The company said its existing capital resources are expected to fund operations through the end of 2027.
MoonLake also noted that up to $400 million in additional non-dilutive financing remains available under its debt agreement with Hercules Capital.
Operating Expenses Reflect Commercial Preparation
Research and development expenses totaled $54.5 million for the three months ended March 31, 2026, compared with $56.0 million in the previous quarter.
General and administrative expenses increased to $15.5 million from $9.2 million, primarily due to $4.8 million in accelerated expense recognition related to the voluntary cancellation of unvested stock option awards.