Pacira BioSciences, Inc. $(PCRX)$ has announced new long-term follow-up data from its Phase 1 clinical trial of PCRX-201, an investigational gene therapy for osteoarthritis of the knee. The results, presented on June 11, 2025, demonstrate that a single intra-articular injection of PCRX-201 was well tolerated and resulted in sustained improvements in pain, stiffness, and function for up to 156 weeks in patients with moderate-to-severe osteoarthritis of the knee. PCRX-201 uses a proprietary high-capacity adenovirus (HCAd) gene therapy vector platform to increase the production of interleukin-1 receptor antagonist, addressing chronic inflammation. The therapy has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Advanced Therapy Medicinal Products $(ATMP)$ designation from the European Medicines Agency. Following these promising Phase 1 results, Pacira BioSciences has initiated dosing in a Phase 2 study, known as the ASCEND study, for further evaluation of PCRX-201 in treating osteoarthritis of the knee.
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