MoonLake’s sonelokimab faces regulatory, commercial tests, RBC says

MoonLake Immunotherapeutics (MLTX) presented a reasonably convincing case for the potential approval of sonelokimab for hidradenitis suppurativa, according to a Friday note from RBC Capital Markets. Management believes the FDA is highly likely to accept its biologics license application, although filing acceptance would not establish that the drug will ultimately receive approval.

For investors, acceptance could provide a near-term catalyst for MoonLake (MLTX) shares, but RBC sees sustained gains depending on greater confidence in the regulatory outcome and the drug’s competitive position. The analysts maintained a sector perform rating, a speculative-risk designation and a $17 price target.

Management estimates only about a 20% chance of receiving priority review, citing FDA resource constraints, according to RBC. That outlook suggests investors should temper expectations for an accelerated review.

MoonLake (MLTX) also outlined potential advantages over bimekizumab, an IL-17A/F inhibitor already marketed for the condition. These include a simpler, less expensive initial treatment regimen, less dermatitis, less severe candidiasis and better patient access. Those proposed benefits underpin its commercial case, but RBC indicated that clearer evidence of market fit would be needed to support a more durable stock recovery.

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