ABBV - Harpoon wins FDA's Fast Track designation for multiple myeloma therapy
Clinical-stage biotech, Harpoon Therapeutics (NASDAQ:HARP) announced on Wednesday that the U.S. Food and Drug Administration (FDA) granted the Fast Track designation for HPN217, a potential treatment for multiple myeloma. The FDA has issued the Fast Track designation for HPN217 in the treatment of patients with relapsed, refractory multiple myeloma (RRMM) who have received at least four lines of therapy. The company is advancing the experimental therapy in a Phase 1/2 clinical trial involving RRMM patients. “We are focused on selecting an initial dose to study in the expansion phase of the ongoing Phase 1/2 clinical trial in the first half of this year…” Harpoon Chief Executive Julie Eastland noted. The Fast Track designation is offered by the FDA to accelerate the development and review of drugs targeted at serious conditions with an unmet medical need. It facilitates developers to conduct frequent communications with the regulator on plans for clinical studies. Under
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Harpoon wins FDA’s Fast Track designation for multiple myeloma therapy