BioCryst signs a $345M licensing deal with Neopharmed Gentili for navenibart in Europe, advancing Phase 3 HAE program toward 2027 filing.
Written By: Pharmacally Medical News Desk
BioCryst Pharmaceuticals, Inc. has entered into a licensing agreement granting an Irish affiliate of Neopharmed Gentili exclusive rights to commercialize navenibart for hereditary angioedema (HAE) in Europe. The deal includes a $70 million upfront payment, with BioCryst eligible to receive up to $275 million in regulatory and sales milestone payments. The company will also receive tiered royalties on net sales ranging from 18% to 30%.
Deal Structure and Financial Terms
Navenibart is an investigational, long-acting plasma kallikrein inhibitor designed for the prevention of HAE attacks. BioCryst is advancing a Phase 3 clinical program that is on track to support regulatory filing by the end of 2027. The agreement provides near-term capital to BioCryst while retaining long-term upside through milestones and royalties, supporting potential investment in additional growth opportunities.
Strategic Expansion and Regional Responsibilities
The agreement builds on an existing collaboration between the companies for ORLADEYO® (berotralstat), BioCryst’s approved oral therapy for HAE. Neopharmed Gentili will utilize its established European commercial infrastructure to support the future launch of navenibart.
Under the terms of the agreement, BioCryst will retain commercialization rights in the United States, while Neopharmed Gentili will lead commercialization in Europe, allowing regional focus and coordinated portfolio management.
Charlie Gayer, President and Chief Executive Officer of BioCryst, said the agreement builds on the existing partnership and leverages Neopharmed Gentili’s regional expertise to expand access to HAE treatments in Europe, while supporting BioCryst’s U.S. commercial focus and financial position.
Alessandro Del Bono, Chief Executive Officer of Neopharmed Gentili, stated that the agreement expands the collaboration between the companies and reflects a shared commitment to patients with HAE, while strengthening the company’s position in rare diseases and supporting its growth in Europe.
Hereditary angioedema is a rare genetic disorder characterized by recurrent episodes of severe swelling affecting the extremities, gastrointestinal tract, or airway. Long-acting plasma kallikrein inhibitors such as navenibart target the kallikrein–kinin pathway to reduce the frequency and severity of attacks.
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