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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

1. Pacira's PCRX-201 presentation scheduled at ASGCT on May 15. 2. Findings will focus on immunogenicity and therapy efficacy. 3. PCRX-201 shows sustained symptom improvement in Phase 1 studies. 4. Regulatory designations enhance PCRX-201's market potential for osteoarthritis. 5. Phase 2 study dosing for PCRX-201 is currently underway.

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Why Bullish?

The positive presentation of Phase 1 data indicates potential growth, similar to previous successful drug launches in biotech that positively impacted stock prices upon favorable study results, like Amgen's launch of Repatha.

How important is it?

The article discusses a significant upcoming presentation related to PCRX-201, which may influence investor sentiment and stock performance due to its innovative potential in treating osteoarthritis.

Why Long Term?

Phase 2 trials can later have a more sustained impact, as successful outcomes may eventually lead to regulatory approval and increased adoption, akin to other gene therapies gaining traction over time.

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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 Speakers: Brendan Lee, Professor of Molecular and Human Genetics, Baylor College of MedicineDerek Jackson, Vice President, Cell & Gene Therapy Product Development at Pacira BioSciencesKilian 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. About PaciraPacira 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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