Fractyl Health gets Dutch authorization for first-in-human trial of RJVA-001 gene therapy for T2D

FRACTYL HEALTH, INC.

Received Clinical Trial Application authorization in the Netherlands for Phase 1/2 first-in-human study of RJVA-001.
RJVA-001 is the first AAV gene therapy candidate to enter clinical development for type 2 diabetes.
First patient dosing and preliminary data expected in the second half of 2026, subject to site activation.
Rejuva clinical development funded within existing cash runway into early 2027; no change to capital plans.
Fractyl becomes dual clinical-stage with Revita in pivotal development and Rejuva entering first-in-human studies.

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