MoonLake Immunotherapeutics Makes Case for Sonelokimab Approval, RBC Says

MT Newswires Live10-16

MoonLake Immunotherapeutics (MLTX) made a "reasonably solid" case for the approvability of sonelokimab as a treatment for hidradenitis suppurativa, RBC Capital Markets said in a Friday note.

The company believes its biologics license application for the drug is very likely to be accepted by the US Food and Drug Administration. However, management sees a low probability of about 20% of obtaining Priority Review, given the agency's resource constraints, the analysts said.

MoonLake highlighted several potential advantages of sonelokimab over bimekizumab, an IL-17A/F inhibitor currently marketed for HS. These include easier and cheaper induction, less dermatitis, less severe candidiasis and improved patient access, according to the note.

The company's stock could rebound upon FDA acceptance of the filing, but more sustained upside may require clearer regulatory de-risking and evidence of commercial fit, the analysts said.

RBC's rating on the company's stock is sector perform, speculative risk, with a price target of $17.

Shares of MoonLake were down 3.6% in Friday trading.

Price: 9.90, Change: -0.37, Percent Change: -3.56

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