BioCryst inks European licensing deal for HAE drug candidate navenibart

Rare Daily Staff

BioCryst Pharmaceuticals it has granted an Irish affiliate of Neopharmed Gentili exclusive rights to commercialize its investigational hereditary angioedema therapy navenibart in Europe under a deal worth up to $345 million.

The agreement includes a $70 million upfront payment to BioCryst, along with up to $275 million in regulatory and sales milestone payments. BioCryst will also receive tiered royalties on net sales ranging from 18 percent to 30 percent.

Navenibart is a long-acting plasma kallikrein inhibitor currently in phase 3 development for hereditary angioedema, a rare genetic disorder that causes recurrent episodes of severe swelling. BioCryst said the program remains on track to support a U.S. regulatory filing by the end of 2027.

The deal expands an existing relationship between the companies, following Neopharmed Gentili’s 2025 acquisition of BioCryst’s European Orladeyo business. Orladeyo, an oral kallikrein inhibitor, is already approved for HAE prevention.

BioCryst said the partnership allows it to focus its commercial operations in the United States while leveraging Neopharmed Gentili’s established European infrastructure for rare disease therapies. The company added that the transaction strengthens its balance sheet while preserving long-term upside through royalties and milestone payments.

Neopharmed Gentili said the agreement reinforces its position in the European rare disease market and builds on its expertise in HAE, aiming to expand treatment options for patients in the region.