BioCryst Reports $601.8M ORLADEYO Revenue with 38% Growth, Eyes $625–645M 2026
BioCryst delivered full-year 2025 ORLADEYO net revenue of $601.8 million, up 38% year-over-year (43% excluding its European divestiture), driving record GAAP operating profit. The company secured FDA approval for pediatric ORLADEYO pellets, completed the Astria Therapeutics acquisition and maintained 2026 ORLADEYO revenue guidance of $625–645 million.
1. Record 2025 Financial Results
BioCryst posted total revenues of $874.8 million and operating profit of $341.0 million for 2025, compared to $450.7 million revenue and a $2.5 million operating loss in 2024. On a non-GAAP basis, revenues reached $592.9 million (45% year-over-year growth) and operating profit was $214.2 million (198% growth), reflecting the exclusion of the European ORLADEYO divestiture and one-time items.
2. Strategic Business Developments
In October 2025, BioCryst completed the sale of its European ORLADEYO business to streamline operations. In December, it earned FDA approval for ORLADEYO oral pellets for patients ages 2 to <12, becoming the first targeted prophylactic therapy for pediatric hereditary angioedema. January 2026 saw the acquisition of Astria Therapeutics, adding injectable monoclonal antibody candidate navenibart to its HAE portfolio.
3. Clinical Pipeline Progress
Navenibart’s Phase 3 ALPHA-ORBIT and ORBIT-EXPANSE trials are underway, with filings targeted by late 2027. Interim ALPHA-SOLAR data demonstrate mean HAE attack rate reductions of 92% (Q3M) and 90% (Q6M), with durable efficacy through 24 months. A Phase 1 trial of BCX17725 for Netherton syndrome has begun dosing, with initial data expected by year-end 2026.