Creative Medical Tech Holdings, Inc. (CELZ) announced on Wednesday that it has received an Orphan Drug Designation from the FDA for CELZ-101.
In response to this development, the stock is surging over 32% in pre-market trading.
Also known as Supercharged Treg Biologic Immunotherapy or ImmCelz, CELZ-101 aims to prevent allograft rejection in patients undergoing pancreatic islet cell transplantation.
This marks a significant advancement for individuals with brittle Type 1 diabetes, a condition characterized by extreme fluctuations in blood glucose levels.
ImmCelz focuses on using a patient's regulatory T cells or Tregs to address autoimmune and alloimmune reactions that can harm insulin-producing cells.
Through a unique process, ImmCelz not only increases these Tregs but also improves their functionality, potentially decreasing the reliance on lifelong immunosuppression in patients with brittle Type 1 diabetes.
In pre-market activity on the Nasdaq, the shares are trading at $5.40, up 32.68%.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.