Cellectar Biosciences Stock Plunges As Cancer-Focused Cancer Firm Pursues Strategic Options
Cellectar Biosciences Stock Plunges As Cancer-Focused Cancer Firm Pursues Strategic Options
The CLOVER-WaM study was conducted in accordance with earlier FDA communications from an end-of-Phase 2 meeting and from a meeting in early 2024, during which the company was informed that positive results for major response rate (MRR) as the primary endpoint could be acceptable to support accelerated approval of iopofosine I 131 for Waldenstrom's macroglobulinemia (WM).On Tuesday, Cellectar Biosciences, Inc. (NASDAQ:CLRB) unveiled a strategic update on its clinical development programs for its proprietary phospholipid ether drug conjugate platform, which targets cancer.
週二，Cellectar BioSciences公司（納斯達克：CLRB）公佈了其專有磷脂醚藥物偶聯平台的臨床開發項目的戰略更新，該平台旨在靶向癌症。
Due to recent communications with the FDA regarding a confirmatory study to support accelerated approval and the regulatory submission for iopofosine I 131, the company has decided to pursue strategic options for the further development and commercialization of this product candidate.
由於最近與FDA的通信涉及支持加速審批的確認研究和iopofosine I 131的監管提交，該公司決定追求戰略期權，以進一步開發和商業化這一產品候選。
Also Read: Cancer-Focused Cellectar Biosciences Stock Trades Lower Despite Meeting Goal In Blood Cancer Study
同樣閱讀：儘管在血液癌症研究中達成目標，專注於癌症的Cellectar BioSciences股票仍然下跌。
The CLOVER-WaM study was conducted in accordance with earlier FDA communications from an end-of-Phase 2 meeting and from a meeting in early 2024, during which the company was informed that positive results for major response rate (MRR) as the primary endpoint could be acceptable to support accelerated approval of iopofosine I 131 for Waldenstrom's macroglobulinemia (WM).
CLOVER-Wam研究是根據早期FDA通信進行的，包括一次階段2會議和2024年初的一次會議，在這次會議上，該公司被告知，作爲主要終點的主要反應率（MRR）的積極結果可能被接受以支持iopofosine I 131對Waldenstrom澱粉樣變病（WM）的加速批准。
Based on a recent Type-C meeting with the FDA, the company says that a submission seeking accelerated approval would need to be based on the MRR data from CLOVER-WaM and enrollment in a randomized, controlled confirmatory study that is designed to generate data on progression-free survival (PFS).
根據最近與FDA的Type-C會議，該公司表示，尋求加速批准的提交需要基於CLOVER-Wam的MRR數據，並需在一項隨機對照確認研究中進行招募，該研究旨在生成無進展生存期（PFS）數據。
Cellectar will focus on those assets it believes have the highest therapeutic potential and opportunity for value creation.
Cellectar將專注於那些它認爲具有最高治療潛力和價值創造機會的資產。
As highlighted by recent acquisitions and collaborations within the radiopharmaceutical sector, precision isotopes like alpha- and Auger-emitters have emerged as the leading therapeutics of interest.
正如近期在放射藥物板塊中的收購和合作所強調的，精密同位素如阿爾法和Auger發射體已成爲主要的治療性藥物。
Consequently, the company will focus its resources on targeting solid tumors by advancing CLR 121225, its actinium-225-based program, and CLR 121125, its iodine-125 Auger-emitting program, into the clinic.
因此，該公司將把資源集中在靶向實體腫瘤上，通過將CLR 121225（其基於Actinium-225的項目）和CLR 121125（其碘-125 Auger發射項目）推進至臨床。
Cellectar expects to file Investigational New Drug applications in the first half of 2025 for both CLR-121225 and CLR-121125, which will allow the initiation of Phase 1 clinical studies in solid tumor cancers.
Cellectar預計將在2025年上半年提交CLR-121225和CLR-121125的研究新藥申請，這將允許啓動實體腫瘤癌症的第一階段臨床研究。
The company will reduce its headcount by approximately 60%, which should be complete by the end of the fourth quarter 2024. The company anticipates that the implementation of the restructuring will extend its cash runway into the third quarter of 2025.
該公司將其員工人數減少約60%，預計將在2024年第四季度結束前完成。該公司預計重組實施將延長其現金流動期至2025年第三季度。
Price Action: CLRB stock is down 73.40% at $0.34 at the last check on Wednesday.
價格走勢：CLRb股票在週三的最新檢查中下跌73.40%，報0.34美元。
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譯文內容由第三人軟體翻譯。
