PARSIPPANY, N.J. - Pacira BioSciences, Inc. (NASDAQ: PCRX) has announced new clinical data showing its gene therapy candidate, PCRX-201, provided sustained improvements in knee pain, stiffness, and function for up to 104 weeks in patients with moderate to severe osteoarthritis of the knee (OAK). These findings are set to be presented at the ACR Convergence, the annual meeting of the American College of Rheumatology.
The results stem from a phase 1 trial involving 72 patients, indicating that a single local injection of PCRX-201 could offer durable pain relief beyond the typical three to six months afforded by existing pain management interventions. Dr. Stanley Cohen, the trial's lead investigator, highlighted the therapy's potential to address the inflammation root cause of OAK pain, potentially offering years of control over patient discomfort.
Patients in the trial were divided into two cohorts, with the second cohort receiving a concurrent pretreatment with a corticosteroid to improve gene transfer tolerability. Notably, this group experienced greater pain reduction and fewer adverse events. Across all doses, improvements in pain ranged from 48% to 65%, while stiffness saw a 53% to 72% enhancement from baseline. More than 70% of participants achieved over 50% pain reduction by week 16. Treatment-related joint effusions were the most common side effect, primarily mild to moderate and resolved within a median of 33 days in the pretreated group.
Pacira's CEO, Frank D. Lee, expressed optimism about advancing PCRX-201's clinical investigation, with a phase 2 study planned for 2025. Lee emphasized the therapy's innovative approach, delivering pain relief directly to the knee joint and potentially slowing the disease's structural progression.
PCRX-201, designed to produce an anti-inflammatory protein, IL-1Ra, directly at the site of the disease, has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Advanced Therapy Medicinal Products (ATMP) designation by the European Medicines Agency, acknowledging its potential as a significant therapeutic advancement.
This news is based on a press release statement and highlights Pacira's commitment to non-opioid pain therapies, including its commercial-stage treatments EXPAREL, ZILRETTA, and iovera°, alongside the development of PCRX-201. The company aims to transform patient lives by providing innovative pain management solutions.
In other recent news, Pacira Biosciences Inc. reported its third quarter 2024 financial results. The company emphasized its commitment to non-opioid pain therapies, with a focus on patient care and a strategic initiative for accelerated growth in 2025. Notably, EXPAREL sales rose from $128.7 million the previous year to $132 million. Pacira's non-GAAP gross margin stood at 78%, and the adjusted EBITDA was reported at $54.7 million. Despite challenges with ZILRETTA, optimism remains, especially with the upcoming NOPAIN reimbursement policy set to be implemented. Furthermore, the company reiterated its 2024 revenue guidance of $680 million to $705 million, with adjusted gross margins between 74% and 76%. These recent developments underscore Pacira's ongoing efforts in the non-opioid pain management space.
InvestingPro Insights
Pacira BioSciences' (NASDAQ: PCRX) promising clinical data for PCRX-201 comes at a crucial time for the company. According to InvestingPro data, Pacira's revenue growth has been modest at 4.4% over the last twelve months, with Q3 2024 showing a 2.83% quarterly increase. This underscores the importance of new therapies like PCRX-201 in driving future growth.
Despite recent market challenges, with the stock experiencing a significant 46.63% decline over the past six months, Pacira has shown resilience. InvestingPro Tips highlight a strong 31.92% return over the last three months, suggesting investor optimism about the company's pipeline and commercial prospects.
The company's focus on non-opioid pain management aligns well with its financial health. An InvestingPro Tip notes that Pacira's liquid assets exceed short-term obligations, indicating a solid financial foundation to support ongoing research and development efforts like PCRX-201.
While Pacira is not currently profitable, analysts predict profitability this year, as per another InvestingPro Tip. This projection, coupled with the potential of PCRX-201 and the company's existing product portfolio, could signal a turning point for Pacira's financial performance.
For investors seeking a deeper understanding of Pacira's potential, InvestingPro offers 8 additional tips, providing a comprehensive view of the company's financial health and market position.
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