Gracell Biotech Gets Orphan Drug Nod For Myeloma Cell Therapy
By Sam Boughedda
Investing.com — Shares of Gracell Biotechnologies Inc. (NASDAQ:GRCL) jumped 14% Friday after the company got the orphan drug designation for the company's multiple myeloma CAR-T cell therapy.
Orphan drug designation offers incentives for drug makers to develop drugs and biologics to treat rare diseases and conditions that affect fewer than 200,000 people in the U.S. Multiple myeloma is a type of blood cancer.
Incentives can include up to seven years of market exclusivity, tax credits for clinical testing, and the reduction or exemption from prescription drug user fees.
Gracell shares traded around $10.25 in the morning session. During premarket trading, they rose over 20%
The drug is currently being assessed in China in investigator-initiated trials. Meanwhile, the tech transfer to Lonza to establish manufacturing of it in the U.S. is continuing, with U.S. IND filing targeting the first half of next year.
Dr. Martina Sersch, Chief Medical Officer of Gracell, said "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."
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Gracell Biotech Gets Orphan Drug Nod For Myeloma Cell Therapy
