MLTX Stock Climbs On Optimism Ahead Of FDA Acceptance Deadline For Lead Drug Filing

• The company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration on September 30. 
• Acceptance of the filing is expected before the end of November, along with a decision on whether it will receive Priority Review. 
• If approved, the company eyes commercializing the drug in HS in the second half of 2027 while also studying it in other indications.

Shares of MoonLake Immunotherapeutics (MLTX) climbed roughly 8% on Wednesday, continuing this week's positive sentiment as investors focused on a near-term regulatory milestone for its lead drug, sonelokimab.

MoonLake is developing Sonelokimab primarily for hidradenitis suppurativa (HS), a chronic inflammatory skin condition with limited effective treatments, as well as for psoriatic arthritis and other inflammatory diseases. In the late-stage VELA program in moderate-to-severe HS, pooled 52-week results from multiple trials showed 67.2% of patients achieving a 75% reduction in inflammatory lesions and 33.1% reaching full reduction, with additional improvements in pain and quality of life and no new safety signals.

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The company submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration on September 30, seeking approval of sonelokimab for moderate-to-severe HS in adults and adolescents aged 12 and older. Acceptance of the filing is expected before the end of November, along with a decision on whether it will receive Priority Review. MLTX has gained 17% so far this week after two weeks of consecutive losses.

MLTX Continues To Advance Sonelokimab

The BLA submission followed a successful final pre-BLA meeting earlier in the year in which the company and the FDA aligned on the overall strategy, label approach, and inclusion of adolescent data from the VELA-TEEN study. If approved, the company eyes commercializing the drug in HS in the second half of 2027 while also studying it in other indications.

Earlier this month, MoonLake reiterated the BLA timeline and noted that enrollment is complete in the second late-stage psoriatic arthritis trial called IZAR-2, with initial results expected in the first quarter of 2027. A late-stage study in palmoplantar pustulosis is also on track to begin enrollment. The company ended the quarter with $498.5 million in cash and marketable securities, providing a runway into mid-2028, with additional non-dilutive capital available under its debt facility.

How Did MLTX Retail Traders React?

On Stocktwits, retail sentiment around MLTX stock stayed within the 'extremely bullish' territory over the past 24 hours, while message volume stayed at 'high' levels.

A Stocktwits user expressed optimism for a doubling in share price once the FDA accepts the application.

Another voiced optimism for an acceptance and also a priority review for the application. An FDA Priority Review sets a goal for the agency to take action on a marketing application within 6 months from the filing date, compared to 10 months for a standard review.

MLTX has gained about 3% year-to-date. 

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