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Pacira BioSciences to Present New Data on Clinical Immunogenicity of Intra-Articular PCRX-201 and Its Implications for Dosing Strategy in Knee Osteoarthritis

Key Takeaway: Pacira BioSciences, Inc. has announced an upcoming presentation of new data regarding their gene therapy candidate, PCRX-201, for knee osteoarthritis. The findings from a Phase 1 study will be presented at the American Society of Gene and Cell Therapy annual meeting on May 15. The data focuses on the impact of neutralizing antibodies on the therapy's efficacy and safety. Given encouraging Phase 1 results, Pacira is advancing to a Phase 2 study of PCRX-201 to treat knee osteoarthritis.
Price reaction · baseline $26.75 (2025-05-01 close) · hit after-hours · 1 other PCRX headline(s) in the window, move may be shared
day 0 close · peak
-1.1%

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POSITIVE FACTORS

  • Exciting upcoming presentation of Phase 1 study findings
  • Promising data indicating sustained improvements in knee pain
  • PCRX-201 has received important regulatory designations (RMAT and ATMP)
  • Phase 2 study (ASCEND) is underway for further development

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+19%
120-day peak, hindsight
Typical move
5.7%
average across 5 past catalysts
Lead asset
FX006
Phase 2 · Osteoarthritis of the Shoulder

Full Press Release Details

BRISBANE, Calif., May 02, 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 an upcoming podium presentation of findings from its Phase 1 study of PCRX-201 (enekinragene inzadenovec), a locally administered gene therapy candidate for osteoarthritis of the knee. The data will be presented at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) in New Orleans on May 15. The presentation will highlight how preexisting and treatment-induced neutralizing antibodies (NAbs) impact the therapy’s efficacy, safety, and redosing potential.
Presentation Title: Understanding the Clinical Immunogenicity of Locally Injected HCAd Vector Provides Insight into Optimizing Dosing Strategy
Presented By: MiJeong Kim, PhD, Senior Director of Translational Sciences at Pacira BioSciences
Date and Time: Thursday, May 15 from 2:15–2:30 PM CT, during the “Immunogenicity/NAb Titers” oral session at ASGCT 2025
Pacira will also host a symposium on HCAd for common diseases, like osteoarthritis.
Symposium Title: High-Capacity Adenoviral Vectors: Advancing Gene Therapy Beyond AAV to Deliver Cost-Effective Therapies for Common Diseases
Brendan Lee, Professor of Molecular and Human Genetics, Baylor College of Medicine
Derek Jackson, Vice President, Cell & Gene Therapy Product Development at Pacira BioSciences
Kilian Guse, Development of Gene Therapy for Musculoskeletal Disorders at Pacira BioSciences
Date and Time: Friday, May 16 from 12:15–1:15 PM CT
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.

Frequently Asked Questions

What is PCRX-201?

PCRX-201 (enekinragene inzadenovec) is a locally administered gene therapy for knee osteoarthritis.

When will the findings on PCRX-201 be presented?

Findings will be presented at the ASGCT annual meeting on May 15, 2025.

What is Pacira BioSciences' focus?

Pacira BioSciences focuses on delivering innovative, non-opioid pain therapies.

Who is presenting at the ASGCT meeting?

MiJeong Kim, PhD, will present at the ASGCT meeting.

What designations has PCRX-201 received?

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

Last updated: May 2, 2025