Shares in Gracell Biotechnologies Inc. (NASDAQ:GRCL) made their way higher Friday morning, after the Food and Drug Administration granted Orphan Drug Designation for Gracell’s, 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.
Orphan Drug Designation incentivizes the development of innovative drugs and biologics for the safe and effective treatment of rare diseases and conditions that affect fewer than 200,000 people in the U.S.
Orphan Drug Designation qualifies the sponsor of the therapy for certain development incentives, including up to seven years of market exclusivity upon regulatory approval, as well as tax credits for clinical testing and reduction of or exemption from prescription drug user fees.
Chief Medical Officer Dr. Martina Sersch says, "We are very excited about being granted Orphan Drug Designation for the treatment of Multiple Myeloma by the U.S. FDA, another key milestone in advancing our program globally. Multiple Myeloma patients are in need of more efficacious and tolerable therapies providing deep and durable responses and ultimately extending progression free and overall survival."
GRCL shares are up $1.32, or 14.7% at $10.30 in the first hour of trading on Friday.
Related Stories
