CASI Pharmaceuticals

CASI

Market cap $19.7M

CID-103 is a potential best-in-class, anti-CD38 monoclonal antibody; binds to unique CD38 epitope AMR is a leading cause of kidney transplant loss with no approved treatments U.S. IND previously approved by FDA for Phase 1 AMR study SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / January 15, 2026 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company developing CID-103, a potentially best-in-class, anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today announced that China National Medical Products Administration (NMPA) has approved a Clinical Trial Application (CTA) to conduct a Phase 1 /2 clinical trial for CID-103 in adults with chronic active renal allograft antibody-mediated rejection (AMR). The Phase 1 / 2 clinical trial is a dose-ranging and safety study evaluating the tolerability and efficacy of CID-103 in patients with renal allograft AMR.

Additional proof of concept data consistent and strengthen data set shared at ASH 2025 Management to host meetings at JP Morgan 44th Annual Healthcare Conference 2026 SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / January 12, 2026 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company developing CID-103, a potentially best-in-class, anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today announced additional data from its Phase 1 open-label study of CID-103 in adult patients with immune thrombocytopenia (ITP). Initial clinical data from this study were presented at the 67th American Society of Hematology Annual Meeting and Exposition on December 7, 2025, in Orlando, Florida.

SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / December 23, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing CID-103, a potential best-in-class, anti-CD38 monoclonal antibody for patients with organ transplant rejection and autoimmune diseases, today announced the Nasdaq Hearings Panel (the "Panel") has granted CASI's request to continued listing on the Nasdaq Stock Market (the "Nasdaq") subject to the Company regaining compliance with the Market Value of Listed Securities (MVLS) Rule 5550(b)(2) by February 17, 2026. The Panel granted the extension after reviewing the recent efforts made by the Company, including the appointments of an experienced Chief Executive Officer and a new Non-Executive Chairman, a commitment to focus on execution of CID-103 development, execution of a convertible note purchase agreement, additional financing initiatives underway, and planned divestiture of China assets.

- Investment to Fund Phase 1 Study in Renal Allograft Antibody-Mediated Rejection (AMR) in China SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / December 11, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI, the "Company"), a clinical-stage biopharmaceutical company developing CID-103, an anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today announced that the Company has entered into a convertible note purchase agreement (the "Purchase Agreement") with ETP Global III Fund LP, a partnership controlled by Dr. Wei-Wu He (the "Purchaser"), pursuant to which the Company will issue and sell convertible notes in an aggregate principal amount of US $20 million to the Purchaser through a private placement. This investment is planned to provide runway to fund the Company through a Phase 1 study in China in renal allograft anti-body-mediated rejection (AMR) as well as development toward a stable, high concentration protein solution for subcutaneous formulation.

SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / December 8, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company developing CID-103, a potentially best-in-class, anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today announced data presented from its Phase 1 open-label study of CID-103 in adult patients with immune thrombocytopenia (ITP) at the 67th American Society of Hematology Annual Meeting and Exposition on December 7, 2025, in Orlando, Florida. This open-label Phase 1 dose escalation study assigned patients to sequential dose-escalating cohorts of intravenous infusions of CID-103 at 30 mg (n=1), 150 mg (n=1), 300 mg (n=3), 600 mg (n=3), and 900 mg (n=3), with a priming dose of CID-103 of either 30 mg or 150 mg administered prior to the cohort dose.

James Huang appointed as Non-Executive Chairman of CASI Board of Directors SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / November 19, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing CID-103, a potential best-in-class, anti-CD38 monoclonal antibody for patients with organ transplant rejection and autoimmune diseases, today announced that its Board of Directors unanimously voted to appoint James Huang, a current independent board member, as Non-Executive Chairman of the Board, effective November 17, 2025. As part of this transition, Dr. Wei-Wu He will step down from the role as Executive Chairman and will remain a member of the Board of Directors.

SOUTH SAN FRANCISCO, CA / ACCESS Newswire / November 14, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on the development of CID-103, a potential best-in-class, anti-CD38 monoclonal antibody for patients with organ transplant rejection and autoimmune diseases, today reported business and financial results for the quarter ended September 30, 2025 (the "third quarter"). "We are focused on capitalizing and advancing our CID-103 clinical program in renal allograft antibody mediated rejection (AMR), first in the U.S. under an already approved IND, followed by China where a regulatory package has been accepted and is under review," said David Cory, CEO of CASI.

SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / November 10, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing CID-103, a potential best-in-class, anti-CD38 monoclonal antibody for patients with organ transplant rejection and autoimmune diseases, today announced that it has received a letter dated November 5, 2025, with a delisting determination from Nasdaq Stock Market LLC (the "Determination"). As previously reported, on May 5, 2025, Nasdaq notified the Company that its market value of listed securities (MVLS) had fallen below the minimum requirement of $35 million for 30 consecutive trading days, and as a result, did not comply with Listing Rule 5550(b)(2).

SOUTH SAN FRANCISCO, CALIFORNIA / ACCESS Newswire / November 4, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing CID-103, a potential best-in-class, anti-CD38 monoclonal antibody for patients with organ transplant rejection and autoimmune diseases, today announced that the CASI management team will participate at the Guggenheim Healthcare Innovation Conference 2025 in a fireside chat at 9:30 AM ET on November 12 in Boston, MA. CASI will also host one-on-one meetings with investors at the conference.

- CID-103 is a potential best-in-class, anti-CD38 monoclonal antibody - Phase 1 dose escalation study in Immune Thrombocytopenia (ITP) results and update SOUTH SAN FRANCISCO, CA / ACCESS Newswire / November 3, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company developing CID-103, a potential best-in-class, clinical stage anti-CD38 monoclonal antibody, for patients with organ transplant rejection and autoimmune diseases, today announced that data will be presented from its Phase 1 open-label study of CID-103 in adult patients with immune thrombocytopenia (ITP) at the 67th American Society of Hematology Annual Meeting and Exposition being held December 6-9, 2025, in Orlando, Florida. Poster Presentation Details Title: 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: Chen Yunfei, ZePing Zhou, Hu Zhou, Ruibin Huang, Zhenyu Yan, Jun Peng, Ming Hou, James Bussel, Alexander Zukiwski, Junping Chen, Lei Zhang Session Name: 311.