Oruka Therapeutics (ORKA) said Monday the US Food and Drug Administration has cleared its investigational new drug application to start the phase 2a trial of ORKA-001 intended for moderate to severe psoriasis.

The company said it aims to enroll about 80 patients under the trial, with a primary endpoint of PASI 100 or completely clear skin.

Oruka Therapeutics said it expects to release efficacy and response duration data from the phase 2a trial in H2 2026.

Shares of Oruka Therapeutics were up more than 7% in recent premarket activity Monday.

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