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BRISBANE, Calif. - Pacira BioSciences, Inc. (NASDAQ: PCRX) has announced preliminary clinical data indicating that its gene therapy candidate, PCRX-201 (enekinragene inzadenovec), retains its effectiveness and safety for osteoarthritis knee pain management despite the presence of anti-Ad5 neutralizing antibodies. The findings were presented today at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting in New Orleans.
The study, an open-label phase 1 trial, involved 72 participants aged 30 to 80 who received varying doses of PCRX-201. The trial examined the impact of pre-existing and treatment-induced anti-Ad5 neutralizing antibodies on the therapy’s performance. Results showed that these antibodies did not compromise the safety or efficacy of PCRX-201 at any dose level. With annual revenue of $702.77 million and analysts expecting net income growth this year, Pacira appears well-positioned to advance its clinical programs. For detailed financial analysis and additional insights, check out the comprehensive Pro Research Report available on InvestingPro.
Patients experienced improved pain, stiffness, and function as measured by the Western Ontario and McMaster Universities Osteoarthritis Index. Additionally, corticosteroid treatment prior to PCRX-201 administration seemed to mitigate treatment-induced antibody titers and reduce knee joint swelling.
Mijeong Kim, the lead investigator of the research at Pacira BioSciences, highlighted the significance of these results in offering a durable treatment option for patients with knee osteoarthritis, who often have limited relief from current therapies.
PCRX-201 utilizes Pacira’s proprietary high-capacity adenovirus vector platform and is designed to increase cellular production of interleukin-1 receptor antagonist to improve chronic inflammation and pain in the knee joint. The therapy’s inducible promoter is engineered to respond to inflammation presence in the joint, enhancing its targeted therapeutic effect.
No serious adverse events related to the treatment or procedure were reported. Treatment-related joint effusions were the most common adverse event, with most cases resolving within a median of 33 days in the corticosteroid pretreated group.
Pacira’s CEO, Frank D. Lee, expressed optimism about the potential of PCRX-201 to provide long-lasting pain relief for the 14 million U.S. patients with osteoarthritis of the knee. Following the encouraging phase 1 results, a phase 2 study is already underway.
In March 2024, PCRX-201 was granted Regenerative Medicine Advanced Therapy designation by the U.S. FDA, and in May 2023, it received Advanced Therapy Medicinal Products designation from the European Medicines Agency.
This information is based on a press release statement from Pacira BioSciences.
In other recent news, Pacira Biosciences reported its first-quarter 2025 earnings, revealing a revenue shortfall with total sales of $164.9 million, missing the forecast of $175.6 million. The decline in ZILRETTA sales, which fell to $23.3 million from $25.8 million, contributed to this shortfall, despite an increase in sales of their flagship product, EXPAREL. The company reported a strong non-GAAP gross margin of 81%, an improvement from 72% the previous year. Meanwhile, Pacira has set a total revenue guidance for 2025 between $725 million and $765 million, focusing on expanding its market share through strategic initiatives. In a separate development, Truist Securities provided insights into the potential impact of a forthcoming executive order on drug pricing, suggesting that generic drug companies like Pacira might face less immediate concern due to their minimal international exposure. Additionally, Truist anticipates that companies with significant sales outside the U.S. may encounter negotiation pressures. The executive order is expected to focus on branded medicines, and Truist believes it could face congressional hurdles.
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