Astria Therapeutics Licenses Japan Rights to Navenibart in $16mln Deal, Kaken Pharmaceutical to Support Phase 3 Trials and Commercialization

Astria Therapeutics has granted exclusive development and commercialization rights in Japan for navenibart, a long-acting monoclonal antibody, to Kaken Pharmaceutical for $16 million upfront. The deal includes potential milestone payments of $16 million, tiered royalties of up to 30%, and partial cost reimbursement. Astria expects the funding to support its operations into 2028.

Title: Astria Therapeutics Partners with Kaken for Navenibart Development in Japan

Astria Therapeutics, Inc. (NASDAQ: ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, has entered into a licensing agreement with Kaken Pharmaceutical, Co., Ltd., to develop and commercialize navenibart, a long-acting monoclonal antibody inhibitor of plasma kallikrein, in Japan. The agreement, announced on August 6, 2025, involves an upfront payment of $16 million, with the potential for an additional $16 million in milestone payments. Additionally, Astria is eligible for tiered royalties up to 30% of net sales and partial cost reimbursement for the Phase 3 program [1].

Under the terms of the agreement, Kaken will provide support for the ALPHA-ORBIT Phase 3 trial in Japan, handle regulatory submissions, and reimburse Astria for a portion of the Phase 3 program costs. This arrangement is expected to extend Astria’s cash runway to support its operating plan into 2028 [1].

Navenibart, currently in Phase 3 development for the preventative treatment of hereditary angioedema (HAE), is designed to provide rapid and sustained HAE attack prevention with a validated mechanism and trusted modality administered subcutaneously every 3 and 6 months [1]. The collaboration with Kaken leverages Kaken's expertise in commercializing innovative therapies and strong relationships with the Japanese medical community, which could facilitate both the Phase 3 trial and future commercialization of navenibart in Japan [1].

Astria Therapeutics aims to empower people living with HAE to live life without limitations from their disease. The company’s mission is to bring life-changing therapies to patients and families affected by allergic and immunologic diseases. The partnership with Kaken aligns with Astria’s strategy to enable broad access to navenibart globally [1].

Kaken Pharmaceutical, a specialty pharmaceutical company in Japan, has a strong track record in developing and commercializing novel pharmaceuticals in various fields, including immune system disorders and rare diseases. The company’s philosophy focuses on improving the quality of life for patients through superior pharmaceuticals [1].

References
[1] https://www.businesswire.com/news/home/20250806414306/en/Astria-Therapeutics-Enters-into-Licensing-Agreement-with-Kaken-Pharmaceutical-to-Develop-and-Commercialize-Navenibart-for-HAE-in-Japan