INTENT Biologics secures FDA pediatric waiver, clears path to late-stage DFU trial for PEP Biologic

INTENT Biologics secures FDA pediatric waiver, clears path to late-stage DFU trial for PEP Biologic

The U.S. Food and Drug Administration (FDA) has granted INTENT Biologics a full pediatric study waiver for its lead candidate, PEP Biologic, under IND 019567. The waiver, part of an agreed Initial Pediatric Study Plan (iPSP), applies to the product’s adult-focused development for diabetic foot ulcers (DFUs), a serious chronic wound indication preparing for pivotal […]

Is Zegen-15 the breakthrough diabetic foot ulcer therapy insurers will finally cover?

Is Zegen-15 the breakthrough diabetic foot ulcer therapy insurers will finally cover?

Zegenex, a Pittsburgh-based biotechnology company focused on regenerative wound care, has secured a $215,000 social-impact investment from the Richard King Mellon Foundation to accelerate formulation and preclinical development of Zegen-15, a first-in-class small-molecule cream targeting chronic wounds, including diabetic foot ulcers. The funding positions Zegenex to begin clinical trials by the end of 2026 and […]