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) received a determination letter from the Nasdaq Hearings Panel dated February 23, 2026, notifying the company that the Panel determined to delist CASI securities for failure to meet continued listing conditions.
The company said its securities will be suspended at the open of business on February 26, 2026, and delisted after completion of applicable processes; CASI does not intend to request a review. The company expects its shares may trade on the OTC market, but noted there is no guarantee a market maker or continued trading will exist. CASI stated the delisting will have no significant impact on operations.
CASI Pharmaceuticals (NASDAQ:CASI) announced on January 15, 2026 that China's National Medical Products Administration (NMPA) approved a Clinical Trial Application to run a Phase 1/2 study of CID-103 in adults with chronic active renal allograft antibody-mediated rejection (AMR).
CID-103 is described as a potentially best-in-class anti-CD38 monoclonal antibody that binds a unique CD38 epitope. The Phase 1/2 trial is a dose-ranging safety study to evaluate tolerability and efficacy in renal allograft AMR. CASI also holds a prior U.S. Phase 1 IND for CID-103 in AMR.
The company framed the approvals as milestones toward developing an approved therapy for a condition with no approved treatments and high risk of transplant loss.
CASI Pharmaceuticals (NASDAQ:CASI) reported additional Phase 1 data for CID-103 in adult immune thrombocytopenia (ITP) patients and disclosed a preliminary acquisition proposal. Updated safety and efficacy data cover doses 30–900 mg with ~5 weeks extra follow-up for ongoing patients. Interim results: primary endpoint met in 12 of 15 evaluable (80%); Complete Response in 10 of 15 evaluable (66%); platelet improvement as early as one week. Safety: manageable profile with two Grade 3 treatment-related events and no dose-limiting toxicities. Separately, a preliminary non-binding proposal dated Jan 7/9, 2026 offers $1.15 per share (~30% premium to 30-day average); no decision has been made by the Board.
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.