Company: PCRX
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001628280-25-050176
Chunk: 6

Company: Pacira BioSciences, Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 2
Chunk 6
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 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, a clinical-stage biotechnology company specializing in drug delivery, announced an exclusive worldwide license agreement for the development and commercialization of AMT-143, a long-acting formulation of the non-opioid analgesic ropivacaine for postsurgical pain. Under the terms of the agreement, AmacaThera will receive an upfront payment of $5.0 million with the potential for future development- and sales-based milestone payments and a tiered royalty on future net product sales. This acquisition aligns with our 5x30 growth strategy to prioritize clinical stage, derisked opportunities that are complementary to our call points in pain management.

AMT-143 is a slow-release, non-opioid local analgesic providing long-acting post-operative pain relief. It is administered via instillation at the time of the surgery and leverages AmacaThera’s innovative hydrogel platform, a fast-gelling physical hydrogel composed of two well-established polymers enabling slow-release while minimizing systemic side effects. It is delivered via a conventional syringe and rapidly forms a depot as it warms to body temperature. In a Phase 1 study, AMT-143 demonstrated sustained release of ropivacaine through 14 days. We and AmacaThera expect to initiate a Phase 2 program in 2026.

Pacira BioSciences, Inc.  |  Q3 2025 Form 10-Q  |  39

Science Center Campus Reduction in Force

In July 2025, as a result of improving manufacturing efficiencies for EXPAREL, we instituted a reduction