Pacira BioSciences Reports Sustained Pain Relief in Osteoarthritis With Gene Therapy Candidate PCRX-201 in Upcoming ACR Presentation
Pacira BioSciences Reports Sustained Pain Relief in Osteoarthritis With Gene Therapy Candidate PCRX-201 in Upcoming ACR Presentation
Clinical data show sustained pain relief for at least 104 weeks following a single injection of PCRX-201.Pacira BioSciences reports positive data on gene therapy PCRX-201 for knee osteoarthritis, showing sustained pain relief for 104 weeks.
pacira biosciences報告基因療法PCRX-201在膝關節骨關節炎方面的積極數據，顯示持續的疼痛緩解達104周。
Quiver AI Summary
Quiver AI 概要
Pacira BioSciences, Inc. recently revealed promising data regarding its gene therapy candidate for osteoarthritis, PCRX-201, which showed sustained improvements in knee pain, stiffness, and function for up to 104 weeks after a single injection. This data, presented at the American College of Rheumatology's ACR Convergence meeting, emerged from a phase 1 trial with 72 patients, demonstrating that PCRX-201 effectively reduced pain and improved joint function while maintaining a favorable safety profile. Lead investigator Dr. Stanley Cohen highlighted that participants experienced significant pain relief lasting over two years, surpassing the typical effects of current pain management options. Pacira plans to advance PCRX-201 into a phase 2 study in 2025, building on its RMAT designation from the FDA, which facilitates expedited development for innovative therapies. PCRX-201 targets the root cause of osteoarthritis knee pain by reducing inflammation through the localized delivery of the anti-inflammatory protein interleukin-1 receptor antagonist.
pacira biosciences公司最近揭示了其骨關節炎基因治療候選藥物PCRX-201的有希望數據，顯示在單次注射後，膝部疼痛、僵硬和功能的持續改善可達104周。該數據在美國風溼病學會的ACR聚會會議上發佈，源於一項涉及72名患者的1期試驗，證明PCRX-201有效減輕疼痛並改善關節功能，同時保持良好的安全性。首席研究員斯坦利 cohen博士強調，參與者經歷了持續超過兩年的顯著疼痛緩解，超出了當前疼痛管理期權的典型效果。pacira計劃在2025年將PCRX-201推進到2期研究，建立在其獲得FDA的RMAt認證之上，以促進創新療法的快速發展。PCRX-201通過局部遞送抗炎蛋白白介素-1受體拮抗劑，瞄準膝關節骨關節炎疼痛的根本原因，減少炎症。
Potential Positives
潛在的積極因素
- Pacira BioSciences has presented new data showing that its gene therapy candidate PCRX-201 provides sustained improvements in knee pain, stiffness, and function for up to 104 weeks after a single local administration, indicating potential long-term efficacy.
- The therapy has a well-tolerated safety profile, with no serious treatment-emergent adverse events related to the treatment reported in the study.
- PCRX-201 received both Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA and Advanced Therapy Medicinal Products (ATMP) designation from the European Medicines Agency, enhancing its development prospects and potential for expedited regulatory review.
- The company plans to advance clinical investigation with a Phase 2 study scheduled for 2025, signaling confidence in the therapy's potential in the growing osteoarthritis treatment market.
- pacira biosciences展示了新的數據，表明其基因療法候選藥物PCRX-201在單次局部給藥後，膝部疼痛、僵硬和功能的改善可持續達104周，表明其潛在的長期療效。
- 該療法具有良好的耐受性，研究中沒有報告與治療相關的嚴重不良事件。
- PCRX-201獲得了FDA的再生醫學高級療法(RMAT)認證和歐洲藥品管理局(EMA)的高級療法藥物產品(ATMP)認證，增強了其開發前景和快速監管審查的潛力。
- 該公司計劃推進臨床研究，定於2025年進行2期研究，標誌着對該療法在不斷增長的骨關節炎治療市場潛力的信懇智能。
Potential Negatives
潛在負面影響
- The reported improvements in knee pain and function are based on data from a phase 1 trial, which typically involves a small number of participants and may not reflect efficacy in larger populations.
- The trial was open-label, potentially introducing bias, as both participants and researchers knew the treatment being administered.
- While no serious treatment-emergent adverse events were reported, the presence of joint effusions as the most common adverse event (occurring in 36%-61% of patients) raises concerns about the safety profile of the therapy.
- 報告中關於膝蓋疼痛和功能改善的結果是基於一期臨床試驗的數據，該試驗通常涉及較少的參與者，可能無法反映在更大人群中的療效。
- 該試驗爲開放標籤，可能引入偏倚，因爲參與者和研究人員都知道正在施用的治療。
- 雖然沒有報告嚴重的治療引發的不良事件，但關節積液作爲最常見的不良事件（發生在36%-61%的患者中）的存在引發了對該療法安全性的擔憂。
FAQ
FAQ
What is PCRX-201?
PCRX-201是什麼？
PCRX-201 is a gene therapy candidate for osteoarthritis designed to reduce inflammation and pain in the knee joint.
PCRX-201是一種針對骨關節炎的基因治療候選藥物，旨在減少膝關節的炎症和疼痛。
How long do pain relief effects last with PCRX-201?
使用PCRX-201的疼痛緩解效果能持續多久？
Clinical data show sustained pain relief for at least 104 weeks following a single injection of PCRX-201.
臨床數據顯示，在單次注射PCRX-201後，持續的疼痛緩解至少爲104周。
What were the study findings for PCRX-201?
關於PCRX-201的研究發現是什麼？
The Phase 1 study indicated significant improvements in knee pain, stiffness, and function among participants over two years.
第一階段研究表明，參與者在兩年內膝蓋疼痛、僵硬和功能方面顯著改善。
Is PCRX-201 safe for patients?
PCRX-201對患者安全嗎？
PCRX-201 demonstrated a well-tolerated safety profile with no serious treatment-emergent adverse events reported in the study.
PCRX-201表現出良好的耐受性，研究中沒有報告嚴重的治療相關不良事件。
When will further studies for PCRX-201 take place?
PCRX-201的進一步研究將在何時進行？
A Phase 2, double-blind study of PCRX-201 is planned for 2025 to continue clinical investigations.
計劃在2025年進行PCRX-201的第二階段雙盲研究，以繼續臨床研究。
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.
免責聲明：這是由GlobeNewswire分發的新聞稿的人工智能生成摘要。用於總結這份稿件的模型可能會出錯。請在這裏查看完整發布。
$PCRX Insider Trading Activity
$PCRX內部交易活動
$PCRX insiders have traded $PCRX stock on the open market 14 times in the past 6 months. Of those trades, 6 have been purchases and 8 have been sales.
$PCRX的內部人士在過去6個月內在公開市場交易了$PCRX股票14次。其中6次爲購買，8次爲出售。
Here's a breakdown of recent trading of $PCRX stock by insiders over the last 6 months:
以下是過去6個月內部人士對$PCRX股票的最近交易情況：
- DARYL GAUGLER (Chief Operating Officer) has traded it 2 times. They made 0 purchases and 2 sales, selling 1,500 shares.
- MARCELO BIGAL has traded it 2 times. They made 2 purchases, buying 4,912 shares and 0 sales.
- LAURA BREGE purchased 1,000 shares.
- MICHAEL J. YANG purchased 2,000 shares.
- FRANK D. LEE (Chief Executive Officer) purchased 8,264 shares.
- MARK FROIMSON purchased 1,400 shares.
- JONATHAN SLONIN (Chief Medical Officer) has traded it 3 times. They made 0 purchases and 3 sales, selling 8,793 shares.
- PAUL J HASTINGS sold 880 shares.
- KRISTEN WILLIAMS (Chief Administrative Officer) sold 7,452 shares.
- LAUREN RIKER (Senior Vice President, Finance) sold 3,970 shares.
- DARYL GAUGLER（首席運營官）交易了2次。他們進行了0次購買和2次銷售，出售了1,500股。
- MARCELO BIGAL交易了2次。他們進行了2次購買，購買了4,912股，且沒有出售。
- LAURA BREGE購買了1,000股。
- MICHAEL J. YANG購買了2,000股。
- FRANk D. LEE（首席執行官）購買了8,264股。
- MARk FROIMSON 購買了1,400股。
- JONATHAN SLONIN (首席醫療官) 交易過3次。他們沒有購買，進行了3次銷售，賣出了8,793股。
- PAUL J HASTINGS 賣出了880股。
- KRISTEN 威廉姆斯 (首席行政官) 賣出了7,452股。
- LAUREN RIKER (高級副總裁，財務) 賣出了3,970股。
To track insider transactions, check out Quiver Quantitative's insider trading dashboard.
要跟蹤內部交易，請查看Quiver Quantitative的內部交易特斯拉-儀表。
$PCRX Hedge Fund Activity
$PCRX 對沖基金活動
We have seen 123 institutional investors add shares of $PCRX stock to their portfolio, and 176 decrease their positions in their most recent quarter.
我們看到123家機構投資者在其投資組合中增加了$PCRX股票，176家在最近一個季度減少了他們的持倉。
Here are some of the largest recent moves:
以下是一些最近最大的交易動態：
- PACER ADVISORS, INC. added 2,799,434 shares (+129.4%) to their portfolio in Q3 2024
- STEPHENS INVESTMENT MANAGEMENT GROUP LLC removed 1,371,561 shares (-100.0%) from their portfolio in Q3 2024
- CLEARBRIDGE INVESTMENTS, LLC removed 1,172,150 shares (-100.0%) from their portfolio in Q2 2024
- BAILLIE GIFFORD & CO removed 806,097 shares (-100.0%) from their portfolio in Q3 2024
- RICE HALL JAMES & ASSOCIATES, LLC removed 730,288 shares (-73.1%) from their portfolio in Q3 2024
- SCHRODER INVESTMENT MANAGEMENT GROUP removed 616,832 shares (-100.0%) from their portfolio in Q3 2024
- ABRDN PLC removed 609,351 shares (-100.0%) from their portfolio in Q3 2024
- PACER ADVISORS, INC. 在2024年第三季度增加了2,799,434股（+129.4%）到他們的投資組合中
- STEPHENS INVESTMENt MANAGEMENt GROUP LLC 在2024年第三季度從他們的投資組合中移除了1,371,561股（-100.0%）
- CLEARBRIDGE INVESTMENTS, LLC 在2024年第二季度從他們的投資組合中移除了1,172,150股（-100.0%）
- BAILLIE GIFFORD & CO 在2024年第三季度從他們的投資組合中移除了806,097股（-100.0%）
- RICE HALL JAMES & ASSOCIATES, LLC 在2024年第三季度從他們的投資組合中移除了730,288股（-73.1%）
- SCHRODER INVESTMENt MANAGEMENt GROUP 在2024年第三季度從他們的投資組合中移除了616,832股（-100.0%）
- ABRDN PLC 在2024年第三季度從他們的投資組合中移除了609,351股（-100.0%）
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
要追蹤對沖基金的股票組合，請查看Quiver Quantitative的機構持股儀表板。
