Astria Therapeutics Enters into Agreement with Kaken Pharmaceutical to Develop and Commercialise Navenibart for HAE Treatment

Thursday, August 07, 2025

Astria Therapeutics has entered into an exclusive licensing agreement with Kaken Pharmaceutical to develop and commercialise navenibart for hereditary angioedema (HAE) in Japan. 

Navenibart is a monoclonal antibody designed to inhibit plasma kallikrein. It is being developed to provide long-lasting protection against HAE attacks through subcutaneous administration every three to six months. The treatment aims to reduce disease burden and improve quality of life for people living with HAE

Navenibart is a long-acting monoclonal antibody inhibitor of plasma kallikrein, currently in Phase 3 development for the preventive treatment of HAE.

Under the agreement, Astria will receive an upfront payment of US$16 million. The company is also eligible to receive up to an additional US$16 million in commercial and sales milestones. Furthermore, the agreement includes tiered royalties on net sales in Japan, with rates of up to 30%, and partial reimbursement of Phase 3 development costs.

Kaken will support the ongoing ALPHA-ORBIT Phase 3 trial in Japan, manage local regulatory submissions, and share the financial responsibility for the late-stage programme. The partnership is expected to expand access to navenibart in Japan and strengthen Kaken’s HAE portfolio.

With the upfront payment and cost reimbursement from Kaken, Astria expects its existing cash resources to support its current operating plans through to 2028.

 

Source: astriatx.com