BioCryst Pharmaceuticals announced that it has granted an Irish affiliate of Neopharmed Gentili an exclusive license to commercialize its investigational plasma kallikrein inhibitor, navenibart, in Europe. The transaction provides BioCryst with a $70 million upfront payment and the potential to receive up to $275 million in future regulatory and sales milestone payments, plus tiered royalties of 18‑30 % on net sales.
The deal builds on a prior collaboration that culminated in the sale of BioCryst’s European ORLADEYO business to Neopharmed Gentili on October 1 2025 for a $250 million upfront payment and up to $14 million in future milestones. That transaction allowed BioCryst to focus its resources on the U.S. market while retaining ownership of its pipeline assets.
The $70 million cash infusion strengthens BioCryst’s balance sheet and reduces reliance on equity financing. In 2025 the company reported its first-ever full‑year profitability, with net income of $263.86 million and ORLADEYO net revenue of $601.8 million, a 38 % year‑over‑year increase. The new licensing agreement adds further liquidity and upside potential as the company continues to grow its rare‑disease platform.
By licensing navenibart, BioCryst retains control of the U.S. program while leveraging Neopharmed Gentili’s established European commercial expertise to accelerate market entry. The partnership complements BioCryst’s oral HAE product, ORLADEYO, by adding a long‑acting injectable candidate that could serve an addressable market of more than 5,000 patients in Europe.
The Phase 3 program for navenibart is on track for a U.S. regulatory filing by the end of 2027, positioning the drug for a potential launch in the coming years. The long‑acting dosing schedule, with every 3‑ or 6‑month injections, could provide a convenient alternative for patients who currently rely on more frequent injections.
"This deal enables both companies to build upon the strong foundation of ORLADEYO and leverages Neopharmed Gentili's expertise in Europe to drive continued execution and positive patient outcomes in the territory," said Charlie Gayer, President and Chief Executive Officer of BioCryst. "This transaction is further illustration of our commitment to focus our business and continue to execute our strategy of delivering commercial excellence in the US while putting the business in a position of financial strength." "We are proud to further strengthen and expand our collaboration with BioCryst Pharmaceuticals through this strategic agreement for navenibart, reinforcing a partnership grounded in a shared commitment to delivering meaningful impact for people living with hereditary angioedema," said Alessandro Del Bono, Chief Executive Officer of Neopharmed Gentili. "This agreement underscores our steadfast dedication to advancing therapeutic innovation in areas of significant unmet medical need, builds upon the strong expertise we have established in Europe in HAE, and further accelerates our long‑term growth trajectory–consolidating our position as a leading European company in the field of rare diseases."
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