PCRX-201 (enekinragene inzadenovec) - (ASCEND)

July 27, 2026: Pacira BioSciences, Inc. (NASDAQ: PCRX) said it has transitioned PCRX-201 (enekinragene inzadenovec), a locally administered gene therapy for osteoarthritis of the knee, to a U.S.-based scalable commercial manufacturing process intended to support future registrational development and commercialization. With drug product from the new process now available, the first patient has been enrolled in Part B of the Phase 2 ASCEND study; Pacira said the manufacturing transition was completed without delaying the ongoing Phase 2 program.

ASCEND is a two-part, multicenter Phase 2 trial (~135 patients; ages 45–80; K-L grade 2–4) randomizing patients 1:1:1 to two PCRX-201 dose levels (1.4×10^10 or 1.4×10^11 genome copies) or saline; all receive intra-articular methylprednisolone pretreatment. Part A randomized 49 patients (enrollment completed June 2026) and topline Part A data are expected by end of 2026. Part B is expected to randomize ~90 patients. Primary endpoint is safety through Week 52; secondary/exploratory endpoints include pain/function measures (NRS, WOMAC, KOOS) and biomarker/immunogenicity assessments, with five-year follow-up.