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Caladrius Biosciences, Inc. (Nasdaq: CLBS) has suspended patient enrollment in its Phase 2b FREEDOM Trial for XOWNA®, aimed at treating coronary microvascular dysfunction (CMD), due to slow enrollment exacerbated by COVID-19 and supply chain issues. An interim analysis of the first 20 patients will be conducted, with results expected by August 2022. This analysis will guide future development strategies for XOWNA®. The company anticipates announcing next steps for the drug by year-end 2022.
Caladrius Biosciences (Nasdaq: CLBS) announced progress in its Phase 1b study of CLBS201 for diabetic kidney disease. The Independent Data Monitoring Committee approved the continuation of patient enrollment after reviewing initial safety and tolerability data, indicating no concerns in the first two patients treated. The company anticipates top-line results from all subjects by Q1 2023. The trial aims to assess the safety of CD34+ regenerative cell therapy in patients with rapidly progressing kidney disease.
Caladrius Biosciences, Inc. (Nasdaq: CLBS) will be presenting at the H.C. Wainwright Global Investment Conference from May 23-26, 2022. David J. Mazzo, Ph.D., the Company’s President and CEO, is scheduled to deliver a corporate overview on May 25 at 9:30 a.m. Eastern time. Caladrius focuses on developing innovative therapies for diseases, including its lead product candidates CLBS16, CLBS12, and CLBS201. The Company also announced a definitive merger agreement with Cend Therapeutics, expected to close in Q3 2022.
Caladrius Biosciences (Nasdaq: CLBS) announced a definitive merger agreement with Cend Therapeutics, designed to enhance its development pipeline and financial standing. The merger, expected to close in Q3 2022, will create Lisata Therapeutics, focusing on solid tumor oncology. Additionally, Caladrius reported a Q1 2022 net loss of $4.2 million, an improvement from $8.1 million a year prior, supported by $88.5 million in cash and marketable securities. The company continues to advance its CD34+ cell therapy, CLBS201, for diabetic kidney disease, with top-line data anticipated by Q1 2023.
Caladrius Biosciences, Inc. (Nasdaq: CLBS) announced its financial results for Q1 2022 will be reported on May 5, 2022, at 4:30 p.m. ET. The company is focused on innovative therapies targeting diseases, particularly through autologous cell therapies. Notable product candidates include XOWNA® (CLBS16), which is undergoing a Phase 2b study for coronary microvascular dysfunction, and CLBS12 (HONEDRA®) in Japan for critical limb ischemia. Additionally, the company recently entered a definitive merger agreement with Cend Therapeutics, expected to close in Q3 2022.
Caladrius Biosciences (CLBS) has announced a definitive merger agreement with Cend Therapeutics to create a new entity named Lisata Therapeutics. This merger, expected to close in Q3 2022, will enhance their oncology product development pipeline, particularly focusing on Cend's CendR Platform™ technology for solid tumors. Caladrius will invest $10 million in Cend to maintain development momentum. The merger values both companies at $90 million, reflecting a 136% premium for Caladrius, with each company's shareholders retaining approximately 50% ownership post-merger.
Caladrius Biosciences (CLBS) announced the treatment of its first patient in a Phase 1b study assessing CLBS201 for diabetic kidney disease (DKD) at the Clinical Advancement Center in San Antonio, Texas. CLBS201 is an autologous CD34+ cell therapy aimed at enhancing renal function in patients with progressive chronic kidney disease. CEO David J. Mazzo emphasized the potential of the therapy to improve patient outcomes, with top-line data expected by Q1 2023. This milestone represents a significant step forward in regenerative medicine for DKD.
Caladrius Biosciences (Nasdaq: CLBS) reported significant advancements in 2021, including the initiation of the Phase 2b FREEDOM Trial for XOWNA® aimed at treating coronary microvascular dysfunction and the start of a new Phase 1 trial for CLBS201 targeting diabetic kidney disease. The company strengthened its financial position with approximately $95 million in cash, expected to fund operations for several years. Despite operational challenges, especially in Japan due to COVID-19, Caladrius remains committed to strategic development opportunities and enhancing shareholder value.
Caladrius Biosciences, Inc. (CLBS) announced it will report its financial results for Q4 and the full year ending December 31, 2021, on March 22, 2022, at 4:30 p.m. ET. The conference call will include a live broadcast, and access details are provided. Caladrius specializes in developing innovative therapies, focusing on first-in-class cell therapy products. Their current candidates include XOWNA® for coronary microvascular dysfunction, CLBS12 for Buerger’s Disease, and CLBS201, targeting diabetic kidney disease.
Caladrius Biosciences (Nasdaq: CLBS) announced it received $2.3 million in non-dilutive funding through the New Jersey Economic Development Authority’s Technology Business Tax Certificate Transfer Program. This funding allows certain New Jersey biotech firms to sell net operating losses and R&D tax credits. Over the past three years, Caladrius has accumulated nearly $15 million from this program, supporting its research and clinical development efforts. The company focuses on innovative therapies for treating diseases, leveraging mechanisms for self-repair in the human body.
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