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BRISBANE, Calif. - Pacira BioSciences, Inc. (NASDAQ:PCRX) has completed patient enrollment in Part A of its Phase 2 ASCEND study for PCRX-201, a gene therapy treatment for knee osteoarthritis, the company announced Wednesday. The $1.01 billion market cap company appears undervalued according to InvestingPro analysis, with a strong free cash flow yield of 12% over the last twelve months.
The two-part clinical trial is evaluating the safety and efficacy of PCRX-201, a locally administered gene therapy designed to increase production of interleukin-1 receptor antagonist (IL-1Ra) in the knee joint to reduce inflammation, pain, and improve function.
Part A of the study has enrolled approximately 45 patients who were randomized to receive one of two doses of PCRX-201 or saline. The therapy features an inducible promoter that activates IL-1Ra expression when inflammation is present and deactivates when inflammation subsides.
"This accomplishment underscores the strategic execution of our clinical team," said Jonathan Slonin, Chief Medical Officer at Pacira BioSciences, according to the company's press release.
The primary endpoint of the study measures treatment-emergent adverse events through 52 weeks, while secondary endpoints include changes in pain and physical function. Pacira expects to report topline results from Part A near the end of 2026.
Part B of the ASCEND study will enroll approximately 90 additional patients using drug product manufactured with the company's proprietary commercial scale process.
PCRX-201 utilizes Pacira's high-capacity adenovirus vector platform, which the company states can deliver genes more efficiently than traditional AAV vectors and at smaller doses. The therapy has received Regenerative Medicine Advanced Therapy designation from the FDA and Advanced Therapy Medicinal Products designation from the European Medicines Agency.
In June, Pacira reported that PCRX-201 demonstrated improvements in knee pain, stiffness, and function through three years following administration in its ongoing clinical program. The stock has gained nearly 30% over the past year, with management actively buying back shares according to InvestingPro analysis.
In other recent news, Pacira BioSciences has entered into an exclusive worldwide license and collaboration agreement with AmacaThera for AMT-143, a long-acting formulation of ropivacaine for postsurgical pain control. The agreement includes an upfront payment of $5 million from Pacira, with potential milestone payments and tiered royalties on future sales. Additionally, Pacira will fund clinical development through to the commercial launch, with Phase 2 trials expected to begin in 2026. Meanwhile, Pacira is facing challenges regarding its flagship non-opioid pain management drug, EXPAREL. The company received Paragraph IV Certification Notices from Qilu Pharmaceutical and The WhiteOak Group, both of which have filed for FDA approval of generic versions of EXPAREL. These notices allege that claims in multiple EXPAREL patents are invalid or unenforceable. In another development, Pacira will present new data from its Phase 1 trial of PCRX-201, a gene therapy candidate for knee osteoarthritis, at an upcoming conference. This presentation will be delivered by Dr. Stanley Cohen and will highlight results from ongoing Phase 2 studies.
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