Welcome to our dedicated page for Cellectar Biosciences NEW news (Ticker: CLRB), a resource for investors and traders seeking the latest updates and insights on Cellectar Biosciences NEW stock.
Cellectar Biosciences Inc. (symbol: CLRB) is a clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative drugs aimed at treating cancer. The company's core focus is leveraging its proprietary Phospholipid Drug Conjugate (PDC) delivery platform, which is designed to target cancer cells specifically, thereby enhancing efficacy and reducing off-target effects.
Cellectar's PDC platform is founded on proprietary phospholipid ether analogs, small molecules known for their selective uptake and retention in various cancers. This technology underpins the company's product pipeline, which includes both therapeutic and diagnostic agents for oncology. The lead therapeutic candidate, CLR 131, utilizes the cytotoxic radioisotope iodine-131 as its payload. CLR 131 has received orphan drug designation from the US FDA and is currently being evaluated in a Phase 1 clinical study for relapsed or refractory multiple myeloma and a Phase 2 clinical study for a range of B-cell malignancies.
In addition to CLR 131, Cellectar is working on developing proprietary PDCs for targeted chemotherapeutic delivery, with several candidates in preclinical stages. The company actively collaborates with research and development partners to expand its PDC platform's applications.
Financially, Cellectar maintains a robust pipeline and continues to secure funding for its clinical and preclinical programs. The company’s innovative approach and partnerships highlight its significant role in the biopharmaceutical landscape.
For more detailed and latest updates, please visit Cellectar’s official website or follow their social media channels.
Cellectar Biosciences (NASDAQ: CLRB) announces strategic changes, including pursuing options for iopofosine I 131 development following FDA communications regarding confirmatory study requirements. The company will shift focus to advancing its alpha- and Auger-emitting radioconjugates into Phase 1 solid tumor studies.
The FDA indicated that accelerated approval would require major response rate data from CLOVER-WaM study and enrollment in a randomized controlled confirmatory study for progression-free survival data. The company plans to file Investigational New Drug applications for CLR-121225 and CLR-121125 in first half of 2025.
As part of restructuring, Cellectar will reduce headcount by approximately 60% by end of Q4 2024, extending cash runway into Q3 2025.
NorthStar Medical Radioisotopes has signed a Master Supply Agreement with Cellectar Biosciences (NASDAQ: CLRB) to provide non-carrier added actinium-225 (n.c.a Ac-225) for Cellectar's radiotherapeutic development programs. The agreement will support Cellectar's CLR 121225, an actinium-labeled phospholipid ether (PLE) therapy, which has shown promising preclinical results in pancreatic, triple negative breast, and other solid tumors. The company plans to initiate Phase 1 clinical trials for CLR 121225 in pancreatic cancer in 2025. This partnership aims to address the scarcity of Ac-225 supply in radiotherapy development.
Cellectar Biosciences reported Q3 2024 financial results and corporate updates. The company reported positive results from Phase 2 CLOVER-WaM pivotal study for iopofosine I 131 in Waldenstrom's macroglobulinemia treatment. The company raised $19.4 million through warrant exercises with potential for additional $73.3 million. Cash position stood at $34.3 million as of September 30, 2024. R&D expenses decreased to $5.5 million from $7.0 million year-over-year, while G&A expenses increased to $7.8 million from $2.4 million. The company plans to file NDA submission in the coming months.
Cellectar Biosciences (NASDAQ: CLRB) has signed a strategic 10-year supply agreement with NorthStar Medical Radioisotopes for non-carrier-added Actinium-225 (Ac-225), a rare radioisotope essential for cancer treatment. The agreement supports Cellectar's CLR 121225 development program, which combines their Phospholipid Ether delivery platform with Ac-225 for solid tumor treatment.
The company plans to begin human clinical trials in 2025, following promising preclinical results in pancreatic, triple negative breast, and other solid tumors. This partnership addresses the critical challenge of Ac-225 scarcity in clinical development and commercialization, securing a reliable supply source for Cellectar's radiotherapeutic development strategy.
Cellectar Biosciences (NASDAQ: CLRB) and SpectronRx have signed a commercial supply agreement for manufacturing iopofosine I 131, a first-in-class cancer therapy. SpectronRx will produce the treatment at facilities in Indiana and Belgium, supporting Cellectar's planned 2025 commercialization. The drug has shown promising results in the CLOVER-WaM pivotal study for Waldenstrom's macroglobulinemia and is being evaluated in Phase 2 studies for multiple myeloma and CNS lymphoma, as well as a Phase 1b study for pediatric high-grade gliomas. The partnership strengthens Cellectar's global manufacturing network and distribution capabilities.
Cellectar Biosciences (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on cancer treatment, has scheduled its third quarter 2024 financial results announcement and corporate update for November 18, 2024, at 8:30 a.m. ET. The company will host a conference call accessible via toll-free number 1-800-717-1738 with conference ID 80659, and a webcast will be available. A replay of the call will be accessible through the company's investor relations website.
Cellectar Biosciences (NASDAQ: CLRB) announced that new data from their Phase 2 CLOVER-WaM study of iopofosine I 131 for Waldenstrom's macroglobulinemia (WM) treatment will be presented at ASH 2024. The study focuses on relapsed and refractory WM patients who received at least 2 prior therapies. The company plans to submit a New Drug Application to the FDA in the coming months and will seek priority review. Dr. Sikander Ailawadhi from Mayo Clinic will present the efficacy and safety results during an oral session on December 9, 2024, at the Marriott Marquis San Diego Marina.
Cellectar Biosciences (NASDAQ: CLRB) has regained compliance with Nasdaq Listing Rule 5250(c)(1) following a letter received from Nasdaq on October 31, 2024. The compliance was achieved after the company filed its restated financial statements, including audited consolidated financials for fiscal years 2022-2023, quarterly statements for various periods in 2022-2023, and quarterly financials for 2024 periods. The filings were submitted to the SEC on October 29, 2024, and Nasdaq has confirmed the matter is closed.
Cellectar Biosciences (NASDAQ: CLRB) announced two presentations on iopofosine I 131 at the 12th International Workshop on Waldenstrom's Macroglobulinemia in Prague. The first presentation by Dr. Jorge Castillo will showcase a case study of complete central nervous system clearance in a patient with Bing-Neel Syndrome (BNS), a rare complication of Waldenstrom's Macroglobulinemia (WM). The second presentation by Dr. Andrei Shustov will review topline data from the CLOVER WaM pivotal study, the largest WM study to date in a highly refractory patient population. Iopofosine I 131, Cellectar's lead product candidate, is a potential first-in-class cancer targeting agent that has demonstrated the ability to cross the blood-brain barrier and shown clinical activity in multiple hematologic malignancies involving the central nervous system.
Cellectar Biosciences (NASDAQ: CLRB) has received a delinquency notification from Nasdaq due to a delay in filing its Q2 2024 10-Q report. The delay is caused by the need to restate previously filed financial statements following a re-evaluation of accounting treatment for warrants issued in October 2022. The restatement affects audited financials for 2022-2023 and unaudited quarterly reports from Q1 2023 to Q1 2024.
Cellectar has until October 21, 2024, to submit a compliance plan to Nasdaq. If accepted, Nasdaq may grant an extension until February 17, 2025. The company expects to complete the restatement process in about six weeks, after which it will file the Q2 2024 10-Q. The notice does not currently affect Cellectar's Nasdaq Capital Market listing.
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