GRCL - Gracell Bio stock jumps 31% on FDA Orphan Drug tag for GC012F

Gracell Biotechnologies (NASDAQ:GRCL) soars 31.5% premarket after the FDA granted Orphan Drug Designation for GC012F, a FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy for the treatment of multiple myeloma. Among the benefits of Orphan Drug status in the U.S. is a seven-year period of market exclusivity for the indication, if approved. "GC012F has demonstrated fast, deep and durable responses in patients with Relapsed/Refractory Multiple Myeloma in an ongoing IIT study in China with most patients on study being high risk according to mSMART 3.0 criteria, a difficult-to-treat patient population," commented Dr. Martina Sersch, Chief Medical Officer of Gracell.

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Gracell Bio stock jumps 31% on FDA Orphan Drug tag for GC012F