Gracell Biotechnologies Inc (GRCL)

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Gracell Gets FDA Orphan Designation for GC012F in Multiple Myeloma >GRCL
6:11 am ET November 19, 2021 (Dow Jones) Print

By Colin Kellaher


Gracell Biotechnologies Inc. on Friday said the U.S. Food and Drug Administration granted orphan-drug designation to GC012F, its lead product candidate, for the treatment of the blood cancer multiple myeloma.

The Shanghai clinical-stage biopharmaceutical company said GC012F has shown fast, deep and durable responses in patients with relapsed/refractory multiple myeloma in an ongoing study in China.

The FDA's orphan-drug program gives special status to drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. and provides for an extended marketing-exclusivity period against competition.


Write to Colin Kellaher at [e-mail]


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