In February , the U.S. Food and Drug Administration or FDA, granted Orphan Drug Designation for soquelitinib for the treatment of T cell lymphoma, providing potential benefits including assistance in the drug development process, tax credits for clinical costs, exemptions from certain FDA fees and seven years of post-approval marketing exclusivity. The Company has also obtained alignment with FDA on its protocol for a registrational Phase 3 clinical trial of soquelitinib in patients with relapsed PTCL and anticipate initiating the trial in the third quarter of 2024. There are currently no FDA fully approved agents for the treatment of relapsed PTCL. Corvus plans to initiate a randomized, placebo-controlled Phase 1 trial of soquelitinib in patients with moderate to severe atopic dermatitis in the second quarter of 2024, with the potential for initial data from the trial before year end 2024.
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