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Pacira BioSciences to Present 3-Year Safety and Efficacy Data of PCRX-201 Following Single Intra-Articular Injection for Moderate-to-Severe Knee Osteoarthritis

Key Takeaway: Pacira BioSciences, Inc. announced the upcoming presentation of new 3-year safety and efficacy data for its gene therapy candidate PCRX-201 at the 2025 EULAR Annual Congress. The data suggests that a single intra-articular injection of PCRX-201 is safe and provides sustained clinical benefits for patients suffering from moderate-to-severe knee osteoarthritis. This therapy features an innovative adenovirus vector design and has received significant regulatory designations, underscoring its promise in treating this prevalent condition.

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POSITIVE FACTORS

  • Presentation of promising 3-year safety and efficacy data for PCRX-201.
  • PCRX-201 demonstrates sustained clinical benefits for knee osteoarthritis patients.
  • Regulatory designations (RMAT and ATMP) highlight the therapy's potential.

Full Press Release Details

-- Data will be featured at EULAR Annual Congress –
BRISBANE, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced new data from its ongoing Phase 1 study of its gene therapy candidate PCRX-201 (enekinragene inzadenovec). The data is being presented at the 2025 European Alliance of Associations for Rheumatology (EULAR) Annual Congress, taking place from June 11-14, in Barcelona, Spain.
Presentation Title: A Single Intra-articular Injection of the Gene Therapy PCRX-201 Was Safe and Provided Sustained Clinical Benefits for Patients With Moderate-to-Severe Knee Osteoarthritis Through 3 Years
Presented By: Philip G. Conaghan, MB BS, PhD, FRACP, FRCP, Professor of Musculoskeletal Medicine, University of Leeds, UK; Director, NIHR Leeds Biomedical Research Centre
Date & Time: Wednesday, June 11 from 3:30 pm – 4:30 pm CEST
About PCRX-201 (enekinragene inzadenovec)
PCRX-201 (enekinragene inzadenovec) features an innovative design based on the company’s proprietary high-capacity adenovirus vector platform. It is currently being studied in the fundamental, underlying chronic inflammatory processes that contribute to “wear and tear” over time in osteoarthritis of the knee, a condition that affects more than 14 million individuals in the U.S. today.
In November 2024, Pacira reported promising data from a large Phase 1 study in which PCRX-201 provided sustained improvements in knee pain, stiffness, and function through two years following local administration, with a well-tolerated safety profile. PCRX-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency. PCRX-201 is the first gene therapy to achieve these clinical results and earn these regulatory designations in osteoarthritis of the knee – a testament to its promise and potential.
Given the promising Phase 1 results, dosing is underway in a Phase 2 study of PCRX-201 (the ASCEND study) for the treatment of knee osteoarthritis. To learn more about PCRX-201 and the company’s clinical development program, please visit the investor events section of the company’s investor website.
Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The Company is also advancing the development of PCRX-201 (enekinragene inzadenovec), a novel, locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit www.pacira.com.

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Frequently Asked Questions

What is the focus of Pacira's PCRX-201 therapy?

PCRX-201 aims to treat chronic inflammatory processes in knee osteoarthritis.

When will data on PCRX-201 be presented?

The data will be presented on June 11, 2025, at the EULAR Annual Congress.

What safety profile does PCRX-201 exhibit?

PCRX-201 has shown a well-tolerated safety profile in Phase 1 studies.

What regulatory designations has PCRX-201 received?

PCRX-201 has received RMAT and ATMP designations from regulatory authorities.

How many people in the U.S. are affected by knee osteoarthritis?

Over 14 million individuals in the U.S. suffer from knee osteoarthritis.

Last updated: May 6, 2025