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CASI Pharmaceuticals, Inc. (symbol: CASI) is a biopharmaceutical company dedicated to the development and commercialization of innovative therapeutic and pharmaceutical products in China, the United States, and globally. The company's core focus is on hematology-oncology, tackling unmet medical needs through advanced treatments and collaborative efforts.
CASI’s product pipeline includes:
- EVOMELA®: Melphalan hydrochloride for injection, used as a high-dose conditioning treatment prior to hematopoietic progenitor cell transplantation in patients with multiple myeloma. It is a significant contributor to CASI’s revenue.
- CNCT19: An autologous CD19 CAR-T cell therapy product designed for patients with B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma. This product, developed in collaboration with Juventas, has recently received market approval in China, marking a critical milestone in cell therapy.
- CID-103: An anti-CD38 monoclonal antibody for the treatment of multiple myeloma. CID-103 has shown promising preclinical efficacy and safety profiles.
- FOLOTYN®: Pralatrexate injection, a treatment for relapsed or refractory peripheral T-cell lymphoma in China, demonstrating a significant impact in addressing critical medical needs.
- BI-1206: A first-in-class FcγRIIB monoclonal antibody under development for relapsed/refractory non-Hodgkin lymphoma in combination with rituximab.
- CB-5339: An oral novel VCP/p97 inhibitor for the treatment of hematological malignancies and solid tumors, currently preparing for clinical trials in China.
CASI's recent achievements include the successful commercialization of FOLOTYN® in China and receiving regulatory approval for CNCT19. Despite competitive pressures, EVOMELA continues to play a critical role in the treatment of multiple myeloma in China, with nearly 10,000 patients treated in 2023.
The company faced challenges such as decreased revenues due to competition and restructuring but remains committed to advancing its pipeline. CASI is also actively involved in arbitration with Juventas over the commercialization rights of CNCT19, asserting its legal rights vigorously.
CASI's forward-looking strategy involves leveraging its regulatory and commercial competencies in China, combined with its global drug development expertise, to launch innovative therapies and maintain market leadership in hematology-oncology.
For more detailed information, visit www.casipharmaceuticals.com.
CASI Pharmaceuticals (Nasdaq: CASI) announced a public offering of 15,853,658 shares at $2.05 per share, with an option for underwriters to purchase 2,378,048 additional shares. The offering is anticipated to generate approximately $32.5 million in gross proceeds, which is expected to close around March 26, 2021. Proceeds will primarily fund working capital, enhance their product portfolio, and support general corporate needs. The offering is conducted under a shelf registration statement that was declared effective in December 2020.
CASI Pharmaceuticals has launched an underwritten public offering of its common stock, with a provision for underwriters to purchase an additional 15%. The exact size and terms are uncertain. Proceeds will support working capital and advance its product portfolio, including acquiring new product rights. The offering occurs under a previously effective shelf registration statement. Key underwriters include Oppenheimer & Co., Mizuho Securities USA, and BTIG. Investors are advised to review the preliminary prospectus for comprehensive details.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) announced a conference call on March 12, 2021, at 8:00 a.m. ET to discuss recent business developments and upcoming milestones. Attendees can dial in using provided numbers for the U.S., China, and Hong Kong, or access the live webcast online. An archived version will be available for one year. CASI is focused on developing pharmaceutical products in the U.S. and China, particularly in hematology oncology. More information on CASI can be found on their website.
Cleave Therapeutics and CASI Pharmaceuticals have signed an exclusive licensing agreement for CB-5339, a novel VCP/p97 inhibitor, aimed at treating hematological malignancies and solid tumors in Greater China. Cleave receives a $5.5 million upfront payment and potential milestone payments totaling $74 million, along with tiered royalties on sales. CB-5339 is currently in Phase 1 clinical trials for AML and myelodysplastic syndrome, and the National Cancer Institute is also evaluating it for solid tumors. This partnership is seen as a strategic move to enhance CB-5339's global development.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) reported preliminary revenues for Q4 and full-year 2020, projecting EVOMELA revenues of approximately $4.8 million for Q4 and $15 million for the year, a 269% increase from 2019. The company anticipates over 50% growth in 2021. Key highlights include ongoing preparations for the CNCT19 drug launch, expected NDA filing in 2021, and promising early data from partner BioInvent's BI-1206 trial. CASI holds $57.1 million in cash as of year-end 2020 and aims for significant advancement in its pipeline in 2021.
CASI Pharmaceuticals (NASDAQ: CASI) announces positive interim results from its partner BioInvent's Phase I/IIa trial of anti-FcγRIIB antibody BI-1206, used in combination with rituximab for patients with relapsed non-Hodgkin's lymphoma (NHL). Six out of nine patients showed encouraging responses, with two achieving sustained complete responses after 12 and 24 months. The trial has seen no dose-limiting toxicities in recent higher dose cohorts. BioInvent plans to identify the recommended Phase II dose based on these results, showcasing the potential for BI-1206 as a significant treatment option for NHL patients.
CASI Pharmaceuticals (NASDAQ: CASI) and BioInvent International AB will host a Key Opinion Leader call on BI-1206 for relapsed or refractory Non-Hodgkin's Lymphoma on January 28, 2021, at 11:30 a.m. ET. Renowned lymphoma expert Dr. Mats Jerkeman will present on current treatment challenges and the potential of BI-1206, a monoclonal antibody targeting resistance to rituximab. Updates on the ongoing Phase I/IIa trial and development plans for BI-1206 in China will also be discussed by CASI's Chairman and CEO, Dr. Wei-Wu He.
CASI Pharmaceuticals, a U.S. biopharmaceutical company, announced that Dr. Wei-Wu He, Chairman and CEO, will present at the H.C. Wainwright Bioconnect Conference on January 11, 2021, at 6:00 AM (ET). This virtual event will feature a webcast available on CASI's website under 'Events & Presentations', with archived replays accessible for 90 days. CASI focuses on developing innovative therapeutics in China and globally, particularly in hematology oncology. The company aims to leverage its regulatory and commercial expertise in China to enhance its market presence.
CASI Pharmaceuticals has announced that the Chinese Center for Drug Evaluation granted Breakthrough Therapy Designation for its partner Juventas Cell Therapy's CNCT19, a potential CD19 CAR-T therapy for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL). This designation is based on initial data from a Phase I study assessing safety and efficacy. Dr. Wei-Wu He highlighted this as a significant regulatory milestone, emphasizing its rarity in China. CASI holds co-commercial rights to CNCT19 and is committed to its development and commercialization.
CASI Pharmaceuticals, Inc. announced the appointment of Weihao Xu as the new Chief Financial Officer on December 16, 2020. Xu, who previously founded a healthcare investment firm and served as CFO for 111, Inc., brings extensive experience in financial operations and corporate strategy. He will report to Dr. Wei-Wu He, Chairman and CEO. The leadership change aims to strengthen CASI's strategic initiatives in 2021 and enhance its focus on innovating therapeutics in hematology and oncology.
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