Pacira BioSciences announced that it has finished enrolling the 45 patients required for Part A of its Phase 2 ASCEND study of PCRX‑201, a helper‑dependent adenovirus gene therapy that boosts interleukin‑1 receptor antagonist production in the knee joint. The study randomized participants to two dose levels—1.4 × 10¹⁰ and 1.4 × 10¹¹ genome copies—alongside a saline control, all preceded by a corticosteroid pretreatment to improve tolerability.
The enrollment milestone is a critical step in the company’s pipeline. Completion of Part A data will inform dose selection and manufacturing scale‑up for Part B, which will enroll roughly 90 patients. PCRX‑201 has already earned U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) and European Medicines Agency Advanced Therapy Medicinal Product (ATMP) designations, positioning it for accelerated regulatory review once efficacy and safety data are available. The gene therapy’s ability to provide disease‑modifying relief could transform the treatment landscape for knee osteoarthritis, a condition affecting more than 15 million U.S. patients and generating a $3.2 billion market in 2024.
Pacira’s existing commercial portfolio—EXPAREL, ZILRETTA, and iovera—focuses on non‑opioid pain management, but the company has faced headwinds with its injectable product line, including Paragraph IV certification notices for generic competition. The PCRX‑201 program therefore represents a strategic diversification into a high‑growth, unmet‑need segment that could broaden the company’s revenue base and reduce reliance on its current product mix.
Financially, Pacira reported Q2 2025 results on August 5, 2025, with total revenue of $181.1 million and non‑GAAP diluted EPS of $0.74, slightly below the $0.89 reported in Q2 2024. The company’s full‑year 2025 revenue guidance was raised to $730 million–$750 million, with a gross‑margin target of 78 %–80 %. Analysts expect Q3 2025 revenue of $182.44 million and EPS of $0.65, indicating a modest upside in earnings relative to the $0.74 reported in Q2 2025. Pacira will report its Q3 2025 earnings on November 6, 2025, providing a near‑term view of how the company’s commercial and pipeline activities are converging.
Looking ahead, the company plans to begin Part B enrollment in the coming months, with topline results from the full ASCEND study anticipated by the end of 2026. Successful demonstration of safety and efficacy could pave the way for regulatory submissions and eventual commercialization, potentially unlocking a substantial share of the osteoarthritis market and reinforcing Pacira’s position as a leader in non‑opioid, regenerative therapies.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.