BioCryst licenses drug candidate for European sale

Durham-based BioCryst Pharmaceuticals, a global biotechnology company focused on developing and commercializing medicines for rare diseases, has signed a European licensing agreement for one of its drug candidates that could bring the company several hundred million dollars in revenue.

BioCryst granted the Irish affiliate of Italian-based pharmaceutical company Neopharmed Gentili an exclusive license to commercialize navenibart for hereditary angioedema (HAE) in Europe. In exchange, Biocryst will receive $70 million upfront, up to $275 million in future regulatory and sales milestone payments, and tiered royalties on sales ranging from 18 to 30 percent.

The agreement builds upon a 2025 deal between the two companies for the European sale of Orladeyo, BioCryst’s commercially approved oral drug to prevent attacks of HAE.

“We are excited to partner with Neopharmed Gentili once again to help bring innovative medicines to patients living with HAE in Europe,” said Charlie Gayer, president and chief executive officer of BioCryst. “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. This transaction is a further illustration of our commitment to focus our business and continue to execute our strategy of delivering commercial excellence in the U.S. while putting the business in a position of financial strength.”

BioCryst obtained Navenibart in January when it acquired the drug’s developer, Boston-based Astria Pharmaceuticals, for about $700 million.

Navenibart is an investigational, long-acting inhibitor of plasma kallikrein, an enzyme involved in HAE. BioCryst is conducting a Phase 3 clinical program of the injectable drug for HAE and intends to file for U.S. regulatory approval by the end of 2027.

Neopharmed Gentili will be responsible for gaining European approval of navenibart.

“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.”

Hereditary angioedema is a rare genetic condition that causes sudden, painful episodes of fluid buildup and swelling in different parts of the body, including the face, hands or feet, or internal organs. It affects about one in every 50,000 people, starting in childhood. About 6,000 people in the United States have a form of the disease, and an estimated 10,000 to 50,000 people in Europe live with HAE.

Founded in 1986 in Birmingham, Ala., BioCryst became a publicly traded company in 1994. Its shares trade on the Nasdaq stock exchange under the symbol BCRX.

BioCryst moved its headquarters to Durham in 2010.