Enlivex Therapeutics receives RMAT designation for Allocetra from FDA

Enlivex Therapeutics (ENLV) said Monday the US Food and Drug Administration granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational immunotherapy Allocetra for treating age-related symptomatic knee osteoarthritis in patients aged 64 and older. The designation was based on phase I/IIa data showing statistically significant improvements in knee pain and physical function versus placebo, with benefits lasting at least six months. Enlivex said it is currently enrolling a 182-patient phase IIb trial in the US and Europe. The company expects topline data by the end of Q2 2027. The FDA also requested a Type B meeting to discuss the program's development and pivotal trial plans, Enlivex said.