Company: PCRX
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001628280-25-050176
Chunk: 103

Company: Pacira BioSciences, Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 1
Chunk 103
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 of our products if some of our customers do not (or perceive that they will not) receive adequate reimbursement from third-party payors or CMS. We will continue to evaluate the impacts of the government shutdown on our business and results of operations. The duration of the current U.S. government shutdown is unknown, nor is the extent of potential agency backlogs once the shutdown concludes, and therefore we are unable to predict the potential impact of a prolonged government shutdown on our business or operations.

Recent Highlights

•In August 2025, the U.S. Patent and Trademark Office, or USPTO, issued U.S. Patent No. 12,370,142 (the ‘142 patent), claiming composition of EXPAREL manufactured by an enhanced process from our large-scale batch process in San Diego, California, which demonstrated a more consistent stability profile as measured by an in-vitro release assay (IVRA). We now have 21 EXPAREL patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”). The ‘142 patent expires in July 2044.

•In October 2025, we presented new data from our Phase 1 clinical trial evaluating PCRX-201 (enekinragene inzadenovec), our novel gene therapy candidate for OA of the knee, at the American College of Rheumatology’s Convergence 2025 meeting. These data demonstrated sustained efficacy from a single IA injection of PCRX-201 with improvements in pain, stiffness and function for up to three years. Importantly, efficacy was observed across all structural severity subgroups including the most severe with a Kellgren-Lawrence (K-L) grade of 4. In addition, investigators highlighted that pre-existing neutralizing antibodies did not affect PCRX-201’s efficacy or safety at all three dose levels tested. Natural immune responses are a major obstacle for gene therapies, and these preliminary data indicate the potential for re-dosing.

Additionally, in November 2025, we announced the conclusion of patient enrollment in Part A of our Phase 2 ASCEND study evaluating PCRX-201 for the treatment of OA of the knee. This milestone marks the first stage of a two-part, multicenter trial designed to evaluate the safety and efficacy of PCRX-201. We remain on track to report results from a pre-specified interim analysis before the end of 2026.

•In November 2025, we and AmacaThera, Inc., or AmacaThera,