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CASI Pharmaceuticals Inc (NASDAQ: CASI) is a biopharmaceutical company developing and commercializing treatments for cancer and blood disorders. The company's focus on oncology and hematology therapeutics generates news across clinical development, regulatory milestones, and commercial operations.
News coverage of CASI typically reflects the company's activities as a clinical-stage and commercial biopharmaceutical organization. Investors and analysts following CASI can expect updates related to clinical trial progress, FDA regulatory decisions, and developments concerning the company's pipeline of oncology candidates including CAR-T therapies and monoclonal antibodies.
As a company with operations spanning multiple geographic markets including the United States and China, CASI's news flow may include international regulatory developments, licensing arrangements, and market access updates. The company's focus on hematologic malignancies such as multiple myeloma and lymphoma means news often relates to these therapeutic areas.
Corporate developments including financial results, strategic transactions, and securities exchange matters also feature in CASI's news coverage. Given the capital-intensive nature of drug development, financing activities and business development transactions represent important news categories for the company.
Bookmark this page to follow CASI Pharmaceuticals news as the company advances its pipeline of cancer therapies and manages its commercial operations in the biopharmaceutical sector.
CASI Pharmaceuticals plans to submit an Investigational New Drug (IND) application to the FDA by the end of 2024 for CID-103, a monoclonal antibody for treating antibody-mediated rejection (AMR) in kidney transplant recipients. CID-103 has shown promising preclinical efficacy and safety. The company believes it has enough capital to complete a Phase II clinical trial for AMR, using proceeds from a private placement financing and existing funds.
Additionally, CASI received a non-binding proposal to acquire its entire China business for $40 million, which includes the assumption of up to $20 million in debt. The Board has formed a Special Committee to evaluate this proposal and other strategic alternatives. No final decisions have been made, and there is no assurance the transaction will proceed.
CASI Pharmaceuticals announced a $15 million private placement financing led by Venrock Healthcare Capital Partners and Foresite Capital, with participation from Panacea Venture and CEO Dr. Wei-Wu He. The financing involves selling 1,020,000 ordinary shares at $5.00 per share and pre-funded warrants for 1,980,000 shares at $4.9999 each. The transaction is expected to close in mid-July 2024, subject to customary conditions. Jefferies is acting as the placement agent. The company plans to file a registration statement with the SEC for the resale of the shares and pre-funded warrants.
On May 15, 2024, CASI Pharmaceuticals (NASDAQ: CASI) announced that the FDA has cleared their Investigational New Drug (IND) application for CID-103. This clearance supports a phase 1/2 study of CID-103 in adults with chronic Immune Thrombocytopenia (ITP), a serious autoimmune disorder. The IND application was submitted on April 12, 2024, and the FDA's approval letter was received on May 13, 2024.
CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that has shown promising preclinical efficacy and safety profiles. Dr. Wei-Wu He, CEO of CASI, highlighted the potential of CID-103 to become a new therapeutic option for ITP, aiming to reduce the disease burden for patients.
CASI Pharmaceuticals reported its Q1 2024 financial results, revealing a significant 59% decrease in total revenue to $3.4 million, compared to $8.3 million in Q1 2023. This decline is primarily due to increased competition from generic melphalan products, inventory management strategies by EVOMELA®'s distributor, and restructuring of the sales force. Despite these challenges, CASI successfully launched its second commercial product, FOLOTYN®, and administered the first patient dose in China. The company also made progress in its pipeline, with promising Phase I results for BI-1206 in China and an IND submission for CID-103 for ITP in the US. Financial highlights include a net loss of $9.5 million and a decrease in cash and investments to $18.2 million as of March 31, 2024.
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