Genprex (NASDAQ:GNPX) issued a clinical update on January 7, 2026, for its diabetes gene therapy program, highlighting significant preclinical progress and regulatory advancements for GPX-002.
The company reported preclinical proof-of-concept data in Type 2 diabetes models, including both mouse and non-human primate studies, demonstrating beta cell rejuvenation and normalization of blood glucose levels.
Earlier studies in Type 1 diabetes models had shown restoration of normal glucose levels along with improved c-peptide and insulin metrics.
Genprex also announced that the manufacturing process for GPX-002 has been successfully transferred to contract development and manufacturing organization (CDMO) partners.
Elsewhere, the company submitted a request for a meeting with the U.S. Food and Drug Administration by the end of 2025, and the meeting has been scheduled for the first quarter of 2026.
The discussion will focus on IND-enabling studies and the path forward to toxicology studies and cGMP clinical-scale production.