Casi Pharmaceuticals Inc Stock Price, News & Analysis

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.

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.