With drug product from the new manufacturing process now available, the first patient has been enrolled in Part B of the Phase 2 ASCEND study. Enrollment in Part A of ASCEND concluded in June, with topline data expected by the end of 2026.

This milestone supports Pacira’s 5x30 growth strategy by advancing one of the company’s most promising pipeline programs while further demonstrating the scalability of the proprietary high-capacity adenovirus (HCAd) platform. Together with PCRX-201’s Regenerative Medicine Advanced Therapy (RMAT) designation and encouraging Phase 1 results, the manufacturing transition further supports the program’s progression toward late-stage development. Importantly, the manufacturing transition was completed without delaying the ongoing Phase 2 ASCEND program.

"Successfully incorporating our intended commercial manufacturing process into our Phase 2 ASCEND study represents an important milestone for the PCRX-201 development program and a testament to the clinical development and manufacturing capabilities of our team," said Frank D. Lee, chief executive officer of Pacira BioSciences. "By generating controlled clinical data with product manufactured using our new process we expect to utilize in later-stage development and commercialization, we are reducing development risk, advancing operational readiness, and strengthening the foundation for potential future registrational studies."

"Advancing Part B of the ASCEND study is an important step in evaluating the potential of this investigational gene therapy for patients living with osteoarthritis of the knee," said Jonathan Slonin, MD, MBA, chief medical officer of Pacira BioSciences. "This milestone reflects years of rigorous scientific and clinical work, including the foundational collaboration with the Brendan Lee Lab at Baylor College of Medicine, whose expertise helped inform the development of this locally administered gene therapy approach."