Kadmon Shares Jump 13% Pre-Bell as FDA Grants Orphan Designation For Graft-vs-Host Disease Treatmen

Kadmon Holdings (KDMN) shares advanced 13% pre-market trade after the company said the U.S. Food and Drug Administration has granted orphan drug designation to its KD025 for the treatment of chronic graft-versus-host disease (cGVHD), a serious complication following allogeneic bone marrow or stem cell transplantation.

KD025 is being studied in an ongoing phase 2 clinical trial in adults with steroid-dependent or steroid-refractory cGVHD and active disease.

The designation qualifies a company for certain financial benefits, including seven years of market exclusivity following marketing approval, tax credits for clinical research costs, eligibility for orphan product grants and the waiver of certain administrative fees.

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