Neopharmed Gentili – through its Irish affiliate – strengthens its European rare disease franchise in HAE acquiring exclusive rights to Navenibart in Europe from BioCryst Pharmaceuticals

The agreement expands the European business built on ORLADEYO® and reinforces Neopharmed Gentili’s ambition to become a leading rare disease player

MILAN, Italy – May 4, 2026 – Neopharmed Gentili S.p.A. (“Neopharmed”), a fast-growing Italian pharmaceutical company focused on high-value therapeutic solutions, today announced that it (through its Irish affiliate) has entered into an exclusive agreement with BioCryst Pharmaceuticals, Inc. for the commercialization of navenibart in Europe, an investigational treatment for hereditary angioedema (HAE).

This agreement represents a further strategic step in Neopharmed Gentili’s evolution, building on the strong foundation established with the 2025 acquisition from BioCryst of the European commercial operations for ORLADEYO® (berotralstat). With the addition of navenibart, Neopharmed strengthens its rare disease platform, expanding its portfolio with an innovative therapy in late-stage development, and is well positioned to become a leader in the HAE space in Europe.

Navenibart is a long-acting plasma kallikrein inhibitor currently in a Phase 3 clinical program, which is on track to support a regulatory filing by the end of 2027.

“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, CEO 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.”

Under the terms of the agreement, BioCryst will receive an upfront payment of $70 million, and is eligible to receive an aggregate of up to $40 million in up to three additional payments upon the achievement of certain regulatory filings and approvals.   The agreement also provides for tiered royalties on net sales ranging from 18% to 30% and certain annual milestone payment amounts based on net sales targets.  BioCryst may be eligible to receive up to an aggregate of $275 million in regulatory and sales milestones.

“We are excited to partner with Neopharmed Gentili once again to help bring innovative medicines to patients living with HAE in Europe. 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 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,” said Charlie Gayer, President and Chief Executive Officer of BioCryst.

The agreement enables a clear geographic division of commercial responsibilities, with BioCryst focused on the U.S. market and the Neopharmed Gentili group leading European operations. This model enhances operational efficiency, strategic alignment, and future launch readiness.

With this transaction, Neopharmed Gentili further solidifies its position as a leading European rare disease platform, strengthening a scalable ecosystem capable of supporting both marketed products and late-stage pipeline assets.

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