Posted by Michael Wonder on 11 Oct 2025
FDA frants RMAT designation to Avobis Bio's implantable cell therapy AVB-114 for Crohn's perianal fistulas
3 October 2025 - Avobis Bio announced today that the US FDA has granted regenerative medicine advanced therapy designation for AVB-114, the Company's lead therapeutic candidate for Crohn's perianal fistulas.
Building upon its existing fast track designation for AVB-114, regenerative medicine advanced therapy designation provides additional benefits including intensive FDA guidance, senior management support, and clinical trial design flexibility to thereby expedite development to address this serious unmet need.
