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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 (NASDAQ:CASI) said the Nasdaq Hearings Panel granted an extension to maintain its listing while it regains compliance with the Market Value of Listed Securities (MVLS) Rule 5550(b)(2) by February 17, 2026. The Panel reviewed recent company actions, including appointing an experienced CEO and a new Non-Executive Chairman, executing a convertible note purchase agreement, pursuing additional financing, and planning a divestiture of China assets.
Nasdaq had notified CASI on May 5, 2025 that its MVLS fell below the $35 million minimum for 30 consecutive trading days; the company missed the initial 180-day cure period ending November 3, 2025 and successfully appealed for the extension. The extension stays suspension of CASI securities while the company pursues compliance.
CASI Pharmaceuticals (NASDAQ:CASI) entered a private placement to issue up to $20 million in convertible notes to ETP Global III Fund LP controlled by Dr. Wei-Wu He to fund a Phase 1 study in renal allograft antibody-mediated rejection (AMR) in China and development of a high-concentration subcutaneous formulation of CID-103.
Notes will be issued in tranches, mature in 36 months, carry 12% annual interest, and are convertible into ordinary shares at a VWAP-based conversion price computed over five trading days, with a floor of $1 and cap of $2 per share; purchaser may convert from day 91 after issuance through maturity. Closings are subject to purchaser satisfaction with business and financial results and use of proceeds.
CASI Pharmaceuticals (NASDAQ:CASI) reported Phase 1 interim results for CID-103 in adult immune thrombocytopenia presented at ASH on December 7, 2025. As of a November 28 cut-off, 11 patients were dosed across 30–900 mg cohorts with priming doses of 30 mg or 150 mg.
Key readouts: the primary platelet response endpoint was met in 8 of 11 (73%) patients; 6 of 8 (75%) responders achieved complete response; platelet improvement observed as early as one week; pharmacodynamic markers decreased consistent with the drug's MOA. Safety showed a manageable profile with two Grade 3 treatment-related events and no dose-limiting toxicities; infusion reactions occurred with the priming dose.
CASI Pharmaceuticals (NASDAQ:CASI) announced a change in board leadership effective November 17, 2025: independent board member James Huang was unanimously appointed Non-Executive Chairman.
As part of the transition, Dr. Wei-Wu He stepped down as Executive Chairman but will remain a member of the board. Management said the change will support strategic planning and advance development of CID-103, the company’s anti-CD38 monoclonal antibody candidate targeting organ transplant rejection and autoimmune diseases.
CASI Pharmaceuticals (NASDAQ:CASI) reported third quarter 2025 results for the period ended September 30, 2025. Key clinical milestones include FDA clearance of an IND for CID-103 in renal allograft AMR, a proposed Phase 1/2 China submission under review, ongoing Phase 1 ITP dosing reaching 900 mg, and an ASH 2025 poster presentation scheduled for December 7, 2025. Financial highlights: 3Q25 revenue $3.1M (-60% YoY), cost of revenue $2.4M, R&D $1.4M, G&A $4.9M, selling & marketing $4.6M, and net loss $10.9M. Cash and cash equivalents were $4.7M as of September 30, 2025. The company raised approximately $5.7M via its ATM facility in 3Q25, is targeting a China divestiture by Q2 2026, and has appealed a Nasdaq delisting determination.
CASI Pharmaceuticals (NASDAQ:CASI) received a delisting determination dated November 5, 2025 from Nasdaq after failing to meet the minimum market value of listed securities (MVLS) $35 million requirement for the applicable period. Nasdaq had notified CASI on May 5, 2025 that its MVLS fell below the $35 million threshold and provided a 180-calendar-day compliance period ending November 3, 2025.
The company has appealed the delisting determination and requested a hearing to present a plan to regain compliance; the appeal will stay the suspension of the company's securities. CASI says it is in dialogue with Nasdaq and will provide material updates to shareholders as available.
CASI Pharmaceuticals (NASDAQ:CASI) will participate at the Guggenheim Healthcare Innovation Conference 2025. The CASI management team is scheduled for a fireside chat on November 12, 2025 at 9:30 AM ET in Boston, MA.
The company noted its focus on CID-103, an investigational anti-CD38 monoclonal antibody for organ transplant rejection and autoimmune diseases. CASI also said it will hold one-on-one investor meetings during the conference.
CASI Pharmaceuticals (NASDAQ:CASI) announced it will present clinical data for CID-103, an anti-CD38 monoclonal antibody, from a Phase 1 open-label dose-escalation study in adult patients with persistent or chronic immune thrombocytopenia (ITP).
The poster will be presented at the 67th American Society of Hematology (ASH) Annual Meeting, December 6-9, 2025, in Orlando, Florida. Presentation details: Poster titled "A dose-escalation and safety study of CID-103 followed by a randomized, open-label, parallel-arm multi-dose study evaluating the efficacy and tolerability of CID-103 in adults with persistent or chronic immune thrombocytopenia." Authors include Chen Yunfei and James Bussel. Session: 311. Disorders of Platelet Number or Function: Clinical and Epidemiological: Poster II. Session date/time: Sunday, December 7, 2025, 6:00 p.m. - 8:00 p.m. PT at Orange County Convention Center - West Halls B3-B4.
CASI Pharmaceuticals (NASDAQ:CASI) has appointed James Huang as an Independent Director to its Board, effective October 1, 2025. Huang brings over 35 years of biotech experience as Founder and Managing Partner of Panacea Venture, and former Managing Partner at Kleiner Perkins China and Vivo Ventures.
The appointment strengthens CASI's leadership as it focuses on developing CID-103, its anti-CD38 monoclonal antibody program for autoimmune diseases and organ transplant rejection. Notably, Panacea Venture, a current CASI shareholder, plans to acquire up to 1.5 million newly issued shares of CASI common stock in a registered transaction.
CASI Pharmaceuticals (NASDAQ:CASI) announced positive safety monitoring results for its Phase 1 clinical trial of CID-103, a potential best-in-class anti-CD38 monoclonal antibody for treating immune thrombocytopenia (ITP). The Safety Monitoring Committee (SMC) has approved dose escalation to cohort 5 (900 mg target dose) following review of cohort 4 (600 mg target dose) and previous cohorts.
The trial has shown favorable safety and tolerability profiles with no serious adverse events or dose-limiting toxicities reported across the first four dose cohorts. The company plans to present detailed clinical results at an upcoming medical conference.
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