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 clinical-stage biopharmaceutical company whose news flow centers on the development and financing of CID-103, an anti-CD38 monoclonal antibody for organ transplant rejection and autoimmune diseases. Company announcements highlight clinical trial progress in immune thrombocytopenia (ITP) and renal allograft antibody-mediated rejection (AMR), as well as regulatory milestones in the United States and China.
Readers of CASI news can follow updates on its Phase 1 and Phase 1/2 studies, including dose-escalation designs, interim safety and efficacy data, and presentations at major medical meetings such as the American Society of Hematology (ASH) Annual Meeting. Press releases describe how CID-103 is being evaluated across multiple dose cohorts, report on platelet response outcomes in ITP, and discuss regulatory clearances such as FDA IND approvals and Chinese CTA approvals for AMR studies.
CASI’s news also covers corporate and capital markets developments, including convertible note financings, at-the-market equity raises, and Nasdaq listing compliance matters. The company has reported receiving a Nasdaq delisting determination related to market value of listed securities, its subsequent appeal, and an extension granted by a Nasdaq Hearings Panel to regain compliance. Governance changes, such as board appointments and the designation of a Non-Executive Chairman, are also detailed in recent releases.
In addition, CASI issues updates on its product portfolio and regulatory environment in China, including the expiration of the Import Drug Registration License for FOLOTYN and the impact on commercialization in that market. For investors and observers, the CASI news feed provides a consolidated view of clinical data releases, regulatory interactions, financing transactions, governance changes, and business updates that shape the company’s progress with CID-103 and related activities.
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.
CASI Pharmaceuticals, Inc. (Nasdaq: CASI) announces that partner Juventas completed a $65 million financing and has initiated the first patient enrollment in a Phase II registration study for CNCT19 (CD19 CAR-T) in China targeting relapsed/refractory B-cell non-Hodgkin lymphoma. CASI's CEO, Dr. Wei-Wu He, views this as a significant milestone and emphasized Juventas' progress in clinical trials. CASI holds a 16% stake in Juventas, highlighting a collaborative co-development and investment strategy aimed at enhancing shareholder returns.
CASI Pharmaceuticals reported Q3 2020 revenues of $4.2 million from EVOMELA, significantly up from $2.7 million year-over-year. The company anticipates full-year revenue to exceed $14 million. R&D expenses grew to $2.8 million, primarily for CID-103's development, while general and administrative costs fell to $5.3 million. The net loss increased to $16.8 million compared to $9.7 million in Q3 2019. Cash and equivalents rose to $74.6 million following a public offering generating $43.7 million.
CASI Pharmaceuticals, Inc. (NASDAQ: CASI) will host a conference call on November 9, 2020, at 4:30 p.m. ET to review its third quarter highlights. The call will provide updates on recent business developments and upcoming milestones. Interested participants can join via phone, with specific numbers for the U.S. and international callers. The Chairman & CEO will lead the discussion, and the call will also be recorded for later replay. CASI focuses on developing and commercializing therapeutics in hematology oncology, primarily in China and the U.S.
BioInvent International AB and CASI Pharmaceuticals have signed an exclusive licensing agreement for the development and commercialization of the anti-FcγRIIB antibody, BI-1206, in Greater China. CASI will handle commercialization, while BioInvent will receive a $5 million upfront payment and could earn up to $83 million in development and commercial milestones, along with royalties on net sales. The agreement includes a $7 million investment in BioInvent shares. BI-1206 is currently under clinical investigation for solid tumors and non-Hodgkin lymphoma.