生产企业：Vega Therapeutics (a wholly owned subsidiary of Star Therapeutics), Incyte (pending acquisition, expected to close Q3 2026)
VGA039 is a first-in-class, Phase 3 investigational monoclonal antibody targeting Protein S for the prophylaxis of bleeding in von Willebrand disease (VWD). It has a novel dual mechanism of action promoting platelet attachment and enhancing fibrin deposition. Administered subcutaneously once monthly, VGA039 has the potential to be the first subcutaneous prophylactic therapy for VWD, replacing current intravenous infusions required 2-3 times weekly. It has received Breakthrough Therapy, Fast Track, orphan drug, and rare pediatric disease designations from the FDA. Originally developed by Vega Therapeutics (a Star Therapeutics subsidiary), VGA039 was acquired by Incyte in June 2026 in a deal valued at up to $2 billion ($1.25B upfront + up to $750M in milestones). The Phase 3 VIVID-6 study (NCT07115004) is ongoing, with results expected in 2029.
VGA039 is a first-in-class, Phase 3 investigational monoclonal antibody targeting Protein S for the prophylaxis of bleeding in von Willebrand disease (VWD). It has a novel dual mechanism of action promoting platelet attachment and enhancing fibrin deposition. Administered subcutaneously once monthly, VGA039 has the potential to be the first subcutaneous prophylactic therapy for VWD, replacing current intravenous infusions required 2-3 times weekly. It has received Breakthrough Therapy, Fast Track, orphan drug, and rare pediatric disease designations from the FDA. Originally developed by Vega Therapeutics (a Star Therapeutics subsidiary), VGA039 was acquired by Incyte in June 2026 in a deal valued at up to $2 billion ($1.25B upfront + up to $750M in milestones). The Phase 3 VIVID-6 study (NCT07115004) is ongoing, with results expected in 2029.
VGA039 is being investigated for the prophylaxis of bleeding in patients with von Willebrand disease (VWD), the most common inherited bleeding disorder. VWD is caused by low or defective von Willebrand factor (VWF), resulting in excessive bleeding that can vary in severity and frequency. Approximately 135,000 people in the United States have been diagnosed with VWD. Current prophylactic treatment options include factor replacement therapies that often require 2 to 3 intravenous infusions each week. VGA039, as a subcutaneously self-administered therapy with once-monthly dosing, has the potential to be the first subcutaneous prophylactic therapy for VWD, broadly applicable across all types of VWD and all types of bleeds. The Phase 3 VIVID-6 study (NCT07115004) is investigating VGA039 in patients with every type of VWD, including those with a high disease burden. Results are expected in 2029.
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