CASI Pharmaceuticals, Inc. (CASI)

CASI Pharmaceuticals traces its origins to EntreMed, Inc., a biotechnology company incorporated in 1991 and based in Rockville, Maryland. EntreMed developed oncology drug candidates and was listed on Nasdaq. In 2014 the company changed its name to CASI Pharmaceuticals and shifted its strategy toward commercialization in China, with a focus on licensed oncology products.

Under its China-focused strategy, CASI marketed EVOMELA, an intravenous melphalan formulation used for conditioning before stem cell transplant and for treatment of multiple myeloma, and licensed other products and programs. It had distribution and licensing agreements with a number of pharmaceutical partners. Its pipeline at different times included cell therapy and antibody candidates, and its common stock traded on the Nasdaq Capital Market under the symbol CASI.

In 2023 the company reorganized as a Cayman Islands holding company, with CASI Pharmaceuticals, Inc. as the successor registrant, and reported under foreign private issuer rules. It restructured its business and refocused on CID-103, a fully human IgG1 anti-CD38 monoclonal antibody for which it holds global rights, aimed at organ transplant rejection and autoimmune diseases.

CID-103 advanced through early clinical development, with a Chinese Phase 1/2 clinical trial authorization and a U.S. Phase 1 investigational new drug approval for chronic active antibody-mediated rejection in kidney transplant patients, and a Phase 1 study in immune thrombocytopenia. The company continued to report net losses and raised capital through equity transactions.

On November 5, 2025, Nasdaq staff notified the company that it no longer qualified for listing under Listing Rule 5550(b)(2). The company appealed on November 10, 2025, and a hearing before the Nasdaq Listing Qualifications Hearings Panel was held on December 11, 2025. The panel issued a decision on December 19, 2025 that granted the company time to regain compliance.

The company did not regain compliance under the terms set by the panel. On February 23, 2026, the panel determined to delist the company's securities, and trading in the ordinary shares was suspended at the opening of business on February 26, 2026. The company stated that it would not request further review and expected its shares to be quoted on the OTC market.

Nasdaq's staff delisting determination became final on April 9, 2026, and Nasdaq issued its delisting determination on May 11, 2026. A Form 25-NSE was filed with the SEC, and removal from listing took effect at the opening of trading on July 6, 2026. The shares have since traded over the counter under the symbol CASIF, and the company continues to operate.