CASI Pharmaceuticals Inc (NASDAQ:CASI) shares jumped 12.4% after the clinical-stage biopharmaceutical company announced the U.S. Food and Drug Administration (FDA) granted clearance for an Investigational New Drug (IND) application for CID-103, its anti-CD38 monoclonal antibody therapy.
The FDA approval enables CASI to initiate a Phase 1 clinical trial to evaluate CID-103 in adult patients suffering from active and chronic active renal allograft antibody-mediated rejection (AMR). The study will focus on assessing dose-ranging, safety, tolerability, and efficacy in kidney transplant recipients experiencing rejection.
“Antibody-mediated rejection remains a significant challenge in kidney transplantation, with limited safe and effective treatments currently available for patients with progressive disease,” said Dr. Alex Zukiwski, Chief Medical Officer of CASI. “There is an urgent need for new therapeutic options for patients with resistant AMR.”
Specializing in therapies for organ transplant rejection and autoimmune disorders, CASI views this IND clearance as a major milestone. CEO David Cory noted that the company will provide further updates on the CID-103 development program in due course.
Kidney transplant rejection represents a critical unmet medical need, with AMR posing particular difficulties for effective treatment using existing therapies.
CASI Pharmaceuticals stock price
This content is for informational purposes only and does not constitute financial, investment, or other professional advice. It should not be considered a recommendation to buy or sell any securities or financial instruments. All investments involve risk, including the potential loss of principal. Past performance is not indicative of future results. You should conduct your own research and consult with a qualified financial advisor before making any investment decisions.