BioCryst Pharmaceuticals (Nasdaq: BCRX) has granted an Irish affiliate of Neopharmed Gentili exclusive rights to commercialize navenibart for hereditary angioedema across Europe, securing USD 70 million upfront alongside up to USD 275 million in regulatory and sales milestones. BioCryst will also receive tiered royalties on European net sales ranging from 18% to 30%. Navenibart is currently in Phase III development, with a US regulatory filing targeted by the end of 2027.
The total potential deal value reaches USD 345 million excluding royalties. The milestone pool combines regulatory and sales triggers, though the individual breakdown between those categories was not disclosed.
Deal context
Navenibart is a long-acting monoclonal antibody that inhibits plasma kallikrein, a serine protease central to the contact activation pathway. By blocking kallikrein, the antibody prevents cleavage of high-molecular-weight kininogen into bradykinin, the mediator responsible for swelling attacks in HAE. The mechanism mirrors that of Orladeyo (berotralstat), BioCryst's approved oral plasma kallikrein inhibitor, but navenibart is administered by subcutaneous injection and is designed for less frequent dosing — positioning it as a next-generation option within the same franchise.
BioCryst is conducting the Phase III program, which includes a core registrational study in type 1 and type 2 HAE (NCT06842823) and a long-term extension study (NCT07204938), with a multinational registration also active in the EU clinical trials system. The program is on track to support a US regulatory filing by the end of 2027.
The agreement is structured as a commercialization license rather than a co-development arrangement. BioCryst retains full responsibility for the Phase III program and regulatory submissions, while Neopharmed Gentili's role is limited to European commercial execution.