- 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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