Pacira BioSciences to Present Findings on PCRX-201 Gene Therapy for Knee Osteoarthritis at ASGCT 2025

Pacira BioSciences announces a presentation on PCRX-201, a gene therapy for knee osteoarthritis, at ASGCT 2025.

Quiver AI Summary

Pacira BioSciences, Inc. announced that it will present findings from a Phase 1 study of its gene therapy candidate, PCRX-201 (enekinragene inzadenovec), for knee osteoarthritis at the 28th Annual Meeting of the American Society of Gene and Cell Therapy on May 15 in New Orleans. The presentation will focus on the effects of neutralizing antibodies on the therapy's efficacy and safety, highlighting insights for optimizing dosing strategies. Additionally, Pacira will host a symposium discussing high-capacity adenoviral vectors for gene therapy, featuring expert speakers from various institutions. PCRX-201 has shown promising results in improving knee pain and function over two years and has received significant regulatory designations, with a Phase 2 study currently underway. Pacira is dedicated to providing innovative, non-opioid pain therapies, including other commercial products like EXPAREL, ZILRETTA, and iovera.

Potential Positives

Announcement of a podium presentation at a major scientific meeting (ASGCT) underscores leadership in innovative, non-opioid therapies, elevating the company's visibility in the field.
Promising Phase 1 study results for PCRX-201 demonstrate sustained improvements in knee pain, stiffness, and function, reinforcing the therapy's potential efficacy and safety.
PCRX-201 has received significant regulatory designations (RMAT and ATMP), highlighting its innovative nature and potential impact on the treatment of osteoarthritis.
The upcoming Phase 2 study (ASCEND study) indicates the company's commitment to advancing its promising therapies, suggesting a positive trajectory for future developments in pain management.

Potential Negatives

Potential concerns regarding the impact of preexisting and treatment-induced neutralizing antibodies (NAbs) on therapy efficacy and safety may raise doubts about the treatment's overall effectiveness.
The need for multiple presentations on clinical immunogenicity and dosing strategies suggests ongoing uncertainties regarding the optimal use of PCRX-201, potentially affecting investor confidence.
While the press release highlights positive results, the inclusion of upcoming studies indicates that long-term outcomes and full safety profiles are still being evaluated, which may lead to apprehensions about the therapy's readiness for broader clinical application.

FAQ

What is PCRX-201 and its purpose?

PCRX-201 (enekinragene inzadenovec) is a gene therapy candidate targeting knee osteoarthritis, aiming to reduce pain and improve function.

When will the findings of the Phase 1 study be presented?

The findings will be presented on May 15, 2025, at the ASGCT Annual Meeting in New Orleans.

Who will present the data at the conference?

The presentation will be given by MiJeong Kim, PhD, Senior Director of Translational Sciences at Pacira BioSciences.

What designations has PCRX-201 received?

PCRX-201 has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Advanced Therapy Medicinal Products (ATMP) designation from the EMA.

What therapies does Pacira offer besides PCRX-201?

Pacira offers EXPAREL®, ZILRETTA®, and iovera®º, all non-opioid pain management options.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

$PCRX Insider Trading Activity

$PCRX insiders have traded $PCRX stock on the open market 2 times in the past 6 months. Of those trades, 0 have been purchases and 2 have been sales.

Here’s a breakdown of recent trading of $PCRX stock by insiders over the last 6 months:

JONATHAN SLONIN (Chief Medical Officer) sold 879 shares for an estimated $16,173
DARYL GAUGLER (Chief Operating Officer) sold 500 shares for an estimated $9,880

To track insider transactions, check out Quiver Quantitative's insider trading dashboard.

$PCRX Hedge Fund Activity

We have seen 108 institutional investors add shares of $PCRX stock to their portfolio, and 122 decrease their positions in their most recent quarter.

Here are some of the largest recent moves:

PACER ADVISORS, INC. removed 1,699,384 shares (-34.2%) from their portfolio in Q4 2024, for an estimated $32,016,394
UBS GROUP AG added 1,184,034 shares (+620.7%) to their portfolio in Q4 2024, for an estimated $22,307,200
POINT72 ASSET MANAGEMENT, L.P. added 1,075,673 shares (+inf%) to their portfolio in Q4 2024, for an estimated $20,265,679
MILLENNIUM MANAGEMENT LLC added 879,473 shares (+145.1%) to their portfolio in Q4 2024, for an estimated $16,569,271
INVESCO LTD. removed 683,699 shares (-74.0%) from their portfolio in Q4 2024, for an estimated $12,880,889
ARROWSTREET CAPITAL, LIMITED PARTNERSHIP removed 505,307 shares (-43.8%) from their portfolio in Q4 2024, for an estimated $9,519,983
MORGAN STANLEY removed 491,115 shares (-30.8%) from their portfolio in Q4 2024, for an estimated $9,252,606

To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.

$PCRX Price Targets

Multiple analysts have issued price targets for $PCRX recently. We have seen 2 analysts offer price targets for $PCRX in the last 6 months, with a median target of $18.5.

Here are some recent targets:

Les Sulewski from Truist Financial set a target price of $25.0 on 01/30/2025
David Amsellem from Piper Sandler set a target price of $12.0 on 11/07/2024

Full Release

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 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.

About Pacira
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 .