Welcome to our dedicated page for Casi Pharmaceuticals news (Ticker: CASI), a resource for investors and traders seeking the latest updates and insights on Casi Pharmaceuticals stock.
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 (NASDAQ: CASI) announced the filing of its annual report on Form 20-F for the fiscal year ending December 31, 2022, with the U.S. Securities and Exchange Commission on April 26, 2023. The report highlights the company's ongoing commitment to developing innovative therapeutics in hematology oncology and other unmet medical needs. Shareholders can request a free hard copy of the audited consolidated financial statements. The company aims to establish a strong presence in the Greater China market, leveraging its regulatory and commercial competencies alongside its global drug development expertise. More details are available on the company's investor relations website.
CASI Pharmaceuticals, a biopharmaceutical firm, reported a $43.1 million revenue for 2022, marking a 26.7% year-on-year growth. The fourth quarter alone accounted for $10.2 million in revenues from EVOMELA®. Despite challenges due to COVID-19 in China, the company treated nearly 10,000 patients with EVOMELA. The company achieved key milestones, including the acceptance of the CNCT-19 NDA by the NMPA in December 2022 and the initiation of the BI-1206 phase I trial. CASI's net loss increased to $40.3 million compared to $35.8 million in 2021. As of December 31, 2022, the firm had $47.1 million in cash and equivalents, up from $38.7 million in 2021. The company plans to enhance its commercial portfolio in 2023 and beyond.
CASI Pharmaceuticals, Inc. (NASDAQ: CASI) has successfully completed a redomiciliation merger, transitioning the company to be incorporated in the Cayman Islands. As part of this move, each share of CASI's common stock will convert into an ordinary share of CASI Cayman, which will continue to trade under the same NASDAQ symbol 'CASI'. This strategic decision aims to leverage regulatory and commercial competencies in China and enhance its position in the biopharmaceutical market, focusing on hematology oncology and unmet medical needs globally.
CASI Pharmaceuticals has received approval from the NMPA for its Clinical Trial Application for CB-5339, a VCP/p97 inhibitor, targeting Multiple Myeloma. The Phase 1 trial aims to assess the safety, pharmacokinetics, and preliminary efficacy of CB-5339 as a single agent in China, with enrollment expected to start in 2023. This development aligns with CASI's strategy to enhance its oncology portfolio and leverage its regulatory expertise in the Greater China market.
CASI Pharmaceuticals announced that the China National Medical Products Administration has accepted the new drug application for CNCT19, an investigational CAR-T therapy targeting relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (r/r B-ALL). This marks CNCT19 as the first CAR-T therapy for B-ALL submitted for NDA and the potential first domestically developed CD19-directed CAR-T therapy in China. The registrational trial showed a 100% drug production success rate and promising efficacy results with an 82.1% overall response rate.
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