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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April 24, 2026 15:15 ET Economics news flow was relatively light this week even as the conflict in the Middle East continued, raising concerns for policymakers. In the U.S., spending data, initial jobless claims and pending home sales were the highlights. Business confidence in the biggest euro area economy was in focus in Europe. Inflation data from Japan gained attention in Asia.