Pacira Biosciences, Inc. Presents New Data on the Effects of Clinical Immunogenicity on Locally Administered PCRX-201 in Patients with Moderate to Severe Osteoarthritis of the Knee

Published: 2025-05-15 08:00:00 ET PCRX

Published on 05/15/2025 at 08:00, updated on 05/15/2025 at 09:20

Pacira BioSciences, Inc. announced new preliminary data which suggests that clinical immunogenicity does not reduce sustained improvements in knee pain, stiffness and function provided by its gene therapy candidate, PCRX-201 (enekinragene inzadenovec), following local administration in patients with mild, moderate, as well as severe osteoarthritis of the knee. The research findings are being presented during a podium session at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting in New Orleans on May 15, 2025, at 2:15 CT. In March 2024, PCRX-201 became the first-ever gene therapy product candidate in osteoarthritis to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA).

RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with the FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of the Biologics License Application (BLA), and other opportunities to expedite development and review. PCRX-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.,S. Food and Drug Administration and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency. PCRX-201 is the first gene therapy to achieve these clinical results and earn these regulatory designations in osteoarthritis of thenee - a testament to its promise and potential.

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