Heartseed loses Novo Nordisk backing for groundbreaking heart failure therapy

Heartseed has lost its long-standing partnership with Novo Nordisk, ending a four-year collaboration on a promising stem cell therapy for heart failure. The Danish pharmaceutical giant announced the termination as part of a wider restructuring plan, leaving Heartseed to continue development of HS-001 independently in Japan.

The decision comes despite positive interim safety results from ongoing Phase 2 trials, which began in early 2025 and remain active as of March 2026.

The partnership between Novo Nordisk and Heartseed started in June 2021, with Novo Nordisk committing $55 million in upfront and near-term payments. Under the original agreement, Novo Nordisk held exclusive rights to develop, manufacture, and commercialise HS-001 outside Japan, while Heartseed retained control over its domestic market.

However, Novo Nordisk's strategic shift towards core areas like diabetes and obesity has led to the termination of the deal. The company is also undergoing significant internal changes, including a recent executive reshuffle and plans to cut 9,000 jobs globally. As a result, Heartseed will no longer receive milestone payments from Novo Nordisk, and all intellectual property related to HS-001 will revert to the Japanese biotech firm.

Heartseed has confirmed it will continue advancing HS-001 in Japan using its existing funds. The therapy, currently in Phase 2 trials, has shown encouraging interim safety data. Meanwhile, the company will seek new partners to explore international development, as no approvals or trials outside Japan have yet taken place.

The split leaves Heartseed responsible for the future of HS-001, with no immediate plans for expansion beyond Japan. The company will rely on its current resources to push forward in clinical trials while searching for alternative collaborations abroad. Novo Nordisk, meanwhile, refocuses its efforts on its core therapeutic areas, marking the end of a once-promising alliance in cardiac cell therapy.