AB2 Bio Secures $30 Million as Nippon Shinyaku Exercises US Commercialization Rights for Tadekinig Alfa

AB2 Bio, a Swiss Health Valley and EPFL based company, has announced that Nippon Shinyaku has exercised its exclusive option to commercialize Tadekinig alfa in the United States, following positive exchanges with the FDA. Under the agreement, AB2 Bio will receive an upfront payment of $30 million and is eligible for up to $600 million in development and commercial milestones, plus royalties on future sales.

For CEO Djordje Filipovic, the number that matters most is far smaller: the infants and children living with primary IL-18-driven monogenic hyperinflammatory syndrome who currently have no FDA-approved treatment option. These patients carry NLRC4 or XIAP mutations that trigger severe systemic hyperinflammation driven by IL-18 — a condition that can rapidly progress to multi-organ dysfunction, irreversible organ damage, and, in the most severe cases, death. “Their families are waiting for a therapy that treats the underlying mechanism, not just the symptoms,” Filipovic said.

Nippon Shinyaku’s decision to exercise its option reflects shared confidence in both the medical and commercial potential of Tadekinig alfa, built on solid clinical data from a completed pivotal Phase 3 programme in the lead indication, which holds an FDA Breakthrough Therapy designation. AB2 Bio will continue to lead BLA preparation and regulatory activities in the US, now alongside a partner with deep experience commercializing rare disease therapies.

“Together, we are well positioned to accelerate bringing this potential therapy to young American patients suffering from this rare and devastating disease, and to potentially deliver a meaningful improvement in treatment,” Filipovic said. “We at AB2 Bio look forward to this collaboration. My sincere thanks to the AB2 Bio and Nippon Shinyaku teams, our researchers and clinical sites, and above all to the patients and families who took part in this programme.

➡️ Source: Press Release | 📸 ©AB2 Bio