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 (NASDAQ:CASI) has announced a significant asset divestiture in China through a definitive Equity and Assets Transfer Agreement with Kaixin Pharmaceuticals, owned by CASI's Chairman and CEO Dr. Wei-Wu He. The $20 million transaction includes the sale of 100% equity interests in two Chinese subsidiaries and the transfer of licensing rights for BI-1206, CID-103, and Thiotepa in specific Asian regions.
The deal involves the assumption of up to $20 million in company debt and requires certain conditions to be met, including resolving judicial freezes on the target equity interests. Post-transaction, CASI will retain rights to CID-103 in Japan and non-Asian regions, EVOMELA®, FOLOTYN®, CNCT19, and CB-5339, focusing on developing CID-103 for organ transplant rejection and autoimmune diseases.
CASI Pharmaceuticals (NASDAQ:CASI) has received a deficiency notice from Nasdaq on May 5, 2025, for failing to maintain the minimum Market Value of Listed Securities (MVLS) requirement of $35 million. The company's MVLS fell below the threshold for 30 consecutive business days from March 20 to May 2, 2025. CASI has been granted a 180-day compliance period until November 3, 2025, to regain compliance by maintaining an MVLS of $35 million or above for at least 10 consecutive business days. The company also does not meet alternative Nasdaq listing requirements. While CASI's securities continue to trade on Nasdaq, failure to regain compliance could result in delisting.
CASI Pharmaceuticals (NASDAQ:CASI) has received an updated non-binding proposal from CEO Dr. Wei-Wu He to acquire its entire China business operations and Asian rights (excluding Japan) for specific pipeline products. The proposed transaction, valued at $20.0 million, includes:
- Assumption of approximately $20.0 million in company debt
- Rights to pipeline products BI-1206, CID-103, and Thiotepa in Asia (excluding Japan)
This proposal updates the previous letter submitted on June 21, 2024, with adjustments to the scope and considerations for the pipeline products. A Special Committee of the board continues to evaluate this proposal and potential alternative strategic options. The company emphasizes that no decisions have been made, and there's no guarantee of a definitive agreement or transaction completion.
CASI Pharmaceuticals (NASDAQ:CASI) reported Q4 2024 revenue of $13.4 million, up 94% year-over-year, while full-year revenue declined 16% to $28.5 million. The company posted a net loss of $39.3 million for 2024, compared to $26.3 million in 2023.
The company is strategically focusing on developing CID-103, an anti-CD38 antibody for organ transplant rejection and autoimmune diseases. Key developments include FDA IND clearance for Immune Thrombocytopenia (ITP) in May 2024, NMPA approval in October 2024, and first patient dosing in January 2025.
CASI completed a $15.0 million private placement with healthcare investors in July 2024. The company's cash position stood at $13.5 million as of December 31, 2024, down from $29.1 million year-over-year. EVOMELA® sales faced challenges due to generic competition, while FOLOTYN® saw its first patient dosed in China in February 2024.
CASI Pharmaceuticals (Nasdaq: CASI) has announced the dosing of the first patient in its Phase 1/2 clinical trial evaluating CID-103 for chronic Immune Thrombocytopenia (ITP) in China. CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that targets a unique epitope and has shown promising preclinical efficacy and safety compared to other anti-CD38 antibodies.
The trial aims to assess the safety and tolerability of CID-103 in adult ITP patients. According to Dr. Wei-Wu He, CASI's Chairman and CEO, this milestone represents significant progress for both the CID-103 program and patients with chronic ITP who currently have treatment options. The study is designed to provide important safety and dose-response data, which could potentially guide CID-103's development for additional autoimmune indications with unmet medical needs.
CASI Pharmaceuticals reported Q3 2024 financial results with total revenue of $7.8 million, marking a 12% decrease year-over-year but a 96% increase from Q2 2024. The company reported a net loss of $8.4 million, compared to $4.5 million in Q3 2023. Key developments include CDE approval for a phase 1/2 study of CID-103 in China for chronic Immune Thrombocytopenia and progress on US IND application for renal allograft AMR. The company also initiated civil litigation against 17 former employees who joined Juventas Cell Therapy
CASI Pharmaceuticals (NASDAQ:CASI) has received Clinical Trial Application (CTA) approval from China's NMPA to conduct a phase 1/2 study of CID-103 in adult patients with chronic Immune Thrombocytopenia (ITP). The China study is part of a global study previously approved by the US FDA in May 2024. CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody that has shown promising preclinical efficacy and safety compared to other anti-CD38 monoclonal antibodies.
CASI Pharmaceuticals (Nasdaq: CASI) has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference, scheduled for September 9-11, 2024, at the Lotte New York Palace. Key members of CASI's management team, including CFO Daniel Lang and CMO Alexander Zukiwski, will be available for one-on-one investor meetings during the event.
A pre-recorded corporate presentation will be accessible to conference attendees in 'Virtual Room 1' starting at 7 a.m. Eastern Time on September 9th. Following the conference, the presentation will be made available on the Investors page of CASI's corporate website. This participation underscores CASI's commitment to engaging with investors and showcasing its progress in developing and commercializing innovative therapeutics and pharmaceutical products.
CASI Pharmaceuticals (Nasdaq: CASI) reported its Q2 2024 financial results and business updates. The company is shifting its strategy to focus on developing therapeutics for organ transplant rejection and autoimmune diseases, with CID-103, an anti-CD38 antibody, as the keystone. CASI received FDA clearance for the IND application of CID-103 for treating adults with ITP and plans to initiate a Phase 1 study by year-end. The company also expects to submit an IND for CID-103 in AMR in Q4 2024.
Financial highlights include:
- Total revenue: $4.0 million (down from $9.8 million in Q2 2023)
- Net loss: $7.0 million (improved from $10.1 million in Q2 2023)
- Cash and cash equivalents: $9.5 million as of June 30, 2024
- Received $15 million from a private placement in July 2024