Gracell Biotech Stock Jumps On Orphan Drug Tag For Multiple Myeloma CAR-T Cell Therapy

by Vandana Singh, Benzinga Editor

November 19, 2021 8:54 AM | 1 min read | Make a Comment

The FDA granted Orphan Drug Designation for Gracell Biotechnologies Inc's GRCL GC012F, FasTCAR-enabled BCMA/CD19 dual-targeting CAR-T cell therapy for multiple myeloma.
The long-term follow-up data for GC012F was presented in June at the ASCO 2021 Annual Meeting and the EHA 2021 Congress.
GC012F is currently being evaluated in investigator-initiated trials in China, including in newly diagnosed Multiple Myeloma patients.
The tech transfer to Lonza to support manufacturing of GC012F in the U.S. is ongoing, with U.S. IND filing targeting 1H of 2022.
Price Action: GRCL shares are up 28.6% at $11.55 during the premarket session on the last check Friday.

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