SPK-8016

**SPK-8016** is an investigational gene therapy being developed for the treatment of hemophilia A, including in patients with factor VIII (FVIII) inhibitors. It employs an adeno-associated viral vector to deliver a gene encoding functional FVIII (likely a B-domain-deleted FVIII transgene) to liver cells. This is intended to enable sustained endogenous production of FVIII, reducing or eliminating the need for frequent exogenous FVIII infusions. The therapy is administered via a single intravenous infusion, and aims to achieve stable and clinically meaningful FVIII activity, reduce bleeding episodes, and improve quality of life for people with severe hemophilia A[1][2][3][4][5].