Pacira BioSciences Receives RMAT Designation For Gene Therapy Product Candidate In Osteoarthritis

(RTTNews) - Pacira BioSciences, Inc. (PCRX) said the FDA has granted Regenerative Medicine Advanced Therapy designation to PCRX-201, the company's intra-articular helper-dependent adenovirus gene therapy product candidate that codes for interleukin-1 receptor antagonist, for the treatment of osteoarthritis of the knee. The company noted that PCRX-201 is the first gene therapy product candidate to receive RMAT designation for osteoarthritis.

The company said RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, potential priority review of the Biologics License Application, and other opportunities to expedite development and review.

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