Pacira's (PCRX) Knee Osteoarthritis Drug Gets FDA's RMAT Tag
Pacira BioSciences, Inc. PCRX announced that the FDA has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to PCRX-201 (enekinragene inzadenovec), the company’s novel, intra-articular HDAd gene therapy product candidate, which is currently being developed to treat osteoarthritis of the knee.
We note that PCRX-201 is the first gene therapy product candidate to receive RMAT designation for the osteoarthritis indication.
The RMAT designation is generally granted to therapies that are intended to treat or cure a serious or life-threatening disease and have the potential to address unmet medical needs. It enables early interactions between the FDA and sponsors to facilitate accelerated approval and potential priority review of a product’s biologics license application.
PCRX-201 also enjoys the Advanced Therapy Medicinal Products designation in the EU for the osteoarthritis indication.
In the past year, shares of Pacira have plunged 23% compared with the industry’s 2.8% decline.
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The FDA’s RMAT designation to PCRX-201 for osteoarthritis was based on preliminary safety and efficacy findings from a phase I proof-of-concept, single ascending dose study. The early-stage study enrolled 72 patients in two three-dose cohorts, a co-administered intra-articular steroid cohort and one that did not receive a steroid.
After at least 52 weeks of treatment, it was observed that PCRX-201 was well tolerated with efficacy observed at all doses and cohorts.
However, the co-administered steroid group achieved the highest level of efficacy, demonstrating a greater percentage of patients with at least a 50% improvement in pain and stiffness scores as well as a meaningful improvement in the knee injury and osteoarthritis outcomes score.
Pacira is slated to present 52-week data from the phase I osteoarthritis study of PCRX-201 at a medical conference in April 2024. The company also expects to present 104-week efficacy and safety data later this year.
PCRX is also currently discussing with investigators and the FDA about the regulatory pathway forward for PCRX-201 to treat osteoarthritis of the knee.
We would like to remind the investors that Pacira acquired PCRX-201 from a Germany-based privately held company, GQ Bio Therapeutics GmbH, in April 2023. PCRX is liable to make certain payments to GQ Bio upon the achievement of certain milestones in the developmental process of PCRX-201.
Pacira BioSciences, Inc. Price and Consensus
Pacira BioSciences, Inc. price-consensus-chart | Pacira BioSciences, Inc. Quote
Zacks Rank and Stocks to Consider
Pacira currently carries a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks from the drug/biotech industry are ADMA Biologics ADMA, FibroGen FGEN and Adicet Bio, Inc. ACET. While ADMA sports a Zacks Rank #1 (Strong Buy), FGEN and ACET carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
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FGEN beat on earnings in two of the trailing four quarters and missed in the other two, delivering an average negative surprise of 2.26%.
In the past 30 days, the Zacks Consensus Estimate for Adicet Bio’s 2023 loss per share has remained constant at $3.39. During the same period, the consensus estimate for Adicet’s 2024 loss per share has widened from $1.80 to $1.81. In the past year, shares of ACET have lost 70.8%.
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