BioCryst Showcases New HAE Clinical Data and Real-World Evidence at EAACI 2026

BioCryst Unveils New Clinical Data & Real-World Evidence Presenting Influence of HAE Portfolio at the 2026 European Academy of Allergy and Clinical Immunology Annual Meeting 

BioCryst Pharmaceuticals, Inc. explored novel clinical data and real-world evidence for ORLADEYO (berotralstat), which is used as the foremost & only targeted oral prophylactic therapy for patients with hereditary angioedema (HAE) aged 2 & geriatric. Alongside, this covers new data from the Phase 1b/2 multicenter, dose-ranging, open-label ALPHA-STAR study of navenibart, an investigational, long-acting, monoclonal antibody plasma kallikrein inhibitor for prophylaxis to mitigate attacks of HAE. Further, these data will be highlighted across various poster presentations during the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting in Istanbul, Turkey, from June 12-15. 

Sandeep Menon, Chief Research and Development Officer of BioCryst, stated that these data strengthen their HAE portfolio, which executes continuous real-world impact for children & adults living with HAE today. They are aiming to advance next-generation treatment solutions to further enhance outcomes, recognize ongoing clinical unmet requirements, & join with patient treatment preferences. 

About New Portfolio Clinical Data  

Recently upgraded analysis of 48-week data from the ongoing APeX-P study, the giant trial of long-term prophylaxis (LTP) in pediatric patients with HAE, showed that assessing once-daily ORLADEYO in HAE patients aged 2 to <12 years will be presented in a poster presentation (Poster D2.498). 

According to Towards Healthcare, the North America real world evidence solutions market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 2.25 billion in 2026 to approximately USD 7.21 billion by 2035, representing a compound annual growth rate (CAGR) of 13.8% from 2026 to 2035.Extensive growth is mainly driven by favourable regulatory landscapes, where the U.S. FDA's commitment to combining RWE into regulatory decision-making, like during label progressions & post-market safety surveillance. Additionally, rising clinical trial spending, pharmaceutical & biotechnology leaders are widely shifting to real-world data to speed up therapeutic development & market access.

Spurring Efforts into AI & Precision Medicine Opportunities Across the Region 

Robust companies are highly fostering the unification of AI & Machine Learning (ML) with Electronic Health Records (EHRs), which enables the predictive modeling of patient results. Specifically, enforcing consulting & analytic services, which support firms in translating huge, unstructured datasets into actionable insights. 

North American nations will have major opportunities for RWE in cancer research & targeted therapies. Whereas the Flatiron Health & other prominent leaders are spotlighting the continuous opportunity in tracking longitudinal patient data to refine tailored treatment protocols & safety profiles.  

According to Towards Healthcare, the North America real world evidence solutions market is expected to grow significantly, driven by increasing adoption of real-world data in regulatory decision-making, rising demand for value-based healthcare, expanding pharmaceutical research activities, technological advancements, and supportive healthcare infrastructure.