Source disclosure: March 05, 2026, 08:30 JST
Published by Pulse News Wire: March 05, 2026, 08:31 JST

AnGes,Inc. [4563.T]

TOKYO, Mar 05 (Pulse News Wire) – AnGes,Inc. (4563.T) announced today that its jointly developed drug candidate, Tie2 Receptor Agonist (AV-001), has received approval from the U.S.

Food and Drug Administration (FDA) for clinical trials aimed at acute resuscitation therapy in severe burn patients. The trial will expand upon ongoing development efforts for ARDS prevention and treatment. Harold Kim, Vice President of Research at Vasomune Therapeutics, Inc., stated, “AV-001 targets the underlying mechanisms causing vascular leakage by activating Tie2 receptors, stabilizing endothelial cells, and reducing inflammation. With this IND approval, we can now evaluate the safety and efficacy of AV-001 during the resuscitation process.” Yamada Hideki, CEO of AnGes,Inc., commented, “We are encouraged by the FDA’s recognition of our program expansion. We aim to continue developing AV-001 to address serious conditions involving vascular leakage.” Vasomune Therapeutics, founded in 2014, focuses on next-generation treatments targeting vascular leakage.

Its lead candidate, Pegevongitide (AV-001), is advancing from preclinical research to clinical applications. The company operates out of Toronto, Canada, and Raleigh, North Carolina. AnGes,Inc., established in 1999, specializes in gene therapy drugs. In 2024, its HGF gene therapy product was designated a breakthrough therapy by the FDA. Currently, the company is also working on Tie2 receptor agonists for viral and bacterial pneumonia and NF-κB decoy oligonucleotides for chronic discogenic lower back pain.

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