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) 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.
CASI Pharmaceuticals (NASDAQ:CASI), a clinical-stage biopharmaceutical company, will present at the upcoming H.C. Wainwright 27th Annual Global Investment Conference. CEO David Cory will deliver a company update on September 8, 2025 at 10:00 AM ET. The company, which focuses on developing therapies for organ transplant rejection and autoimmune diseases, will also conduct one-on-one meetings with investors during the conference.
CASI Pharmaceuticals (NASDAQ:CASI) has appointed Dr. Barbara Krebs-Pohl as an Independent Director to its Board of Directors. Dr. Krebs-Pohl brings 27 years of biotechnology experience, notably serving as Chief Business Officer at MorphoSys where she led its $2.9B acquisition by Novartis. She also played key roles in significant transactions including Constellation Pharmaceuticals' acquisition by MorphoSys and HI-Bio's $1.8B acquisition by Biogen.
The appointment comes at a crucial time following CASI's recent FDA IND acceptance for CID-103, their antibody-mediated rejection treatment. Dr. Krebs-Pohl currently serves as Managing Director of the Foundation for Stem Cell Research and Regenerative Medicine and as Partner at Viopas Venture Consulting.
CASI Pharmaceuticals (NASDAQ:CASI) reported its Q2 2025 financial results and business updates. The company achieved $4.2 million in revenue, a 5% year-over-year increase. Key developments include FDA clearance for CID-103's IND application in renal allograft antibody-mediated rejection (AMR) and ongoing Phase 1/2 trials in immune thrombocytopenic purpura (ITP).
CASI entered a significant $20 million Equity and Assets Transfer Agreement with Kaixin Pharmaceuticals, involving the sale of Chinese subsidiaries and certain regional rights for pipeline products. The company appointed David Cory as CEO and reported a net loss of $13.4 million for Q2 2025, with cash reserves declining to $6.7 million from $13.5 million in December 2024.
CASI Pharmaceuticals (NASDAQ:CASI), a clinical-stage biopharmaceutical company specializing in therapies for organ transplant rejection and autoimmune diseases, has announced its participation in the upcoming Cantor Global Healthcare Conference.
CEO David Cory will engage in a fireside chat on September 3, 2025, at 11:30 AM ET in New York City. The company will also conduct one-on-one investor meetings during the conference. Investors can access the live webcast through CASI's website, with a replay available for 90 days following the event.
CASI Pharmaceuticals (NASDAQ:CASI) has received FDA clearance for its Investigational New Drug (IND) application for CID-103, a potential best-in-class anti-CD38 monoclonal antibody targeting renal allograft antibody-mediated rejection (AMR). The company plans to initiate a Phase 1 clinical trial to evaluate the safety, tolerability, and efficacy of CID-103 in adults with active and chronic active renal allograft AMR.
AMR is identified as a leading cause of kidney transplant failure, often resulting in dialysis or repeat transplantation. The Phase 1 study will focus on dose-ranging and safety assessments, addressing an urgent medical need in transplant medicine where current treatment options are limited.
CASI Pharmaceuticals (NASDAQ:CASI) has appointed David Cory as its new Chief Executive Officer and Board member, while former CEO Wei-Wu He transitions to Executive Chairman. Cory brings over 30 years of operational experience in biotech and pharma, with a track record of raising over $1B in capital markets and multiple successful company exits.
The appointment aims to focus CASI's U.S. operations on developing CID-103, a potential best-in-class anti-CD38 monoclonal antibody. The drug is currently in Phase 1/2 trials for chronic immune thrombocytopenia (ITP), with an IND submitted for trials in renal allograft antibody-mediated rejection (AMR).
Cory's previous roles include CEO positions at LIB Therapeutics and Eiger BioPharmaceuticals, where he led successful drug developments and regulatory approvals. His experience spans startups like InterMune and CoTherix, which saw collective exits of approximately $9 billion.
CASI Pharmaceuticals (NASDAQ: CASI) has announced it will host a live conference call and webcast on Wednesday, May 21, 2025, at 8:00 a.m. PT/11:00 a.m. ET to provide business and clinical updates. The biopharmaceutical company, which focuses on developing and commercializing innovative therapeutics and pharmaceutical products, will make presentation materials available in the Investors section of their website following the conference call.