BioCryst Pharmaceuticals

The Japanese Ministry of Health has approved ORLADEYO (berotralstat) for prophylactic treatment of hereditary angioedema (HAE) in patients aged 2 to under 12 years. The oral granule formulation showed a consistent safety profile and was generally well tolerated in the APeX-P study of 29 children; the most common treatment-related adverse event was nasopharyngitis. BioCryst will launch the drug in Japan with distribution partner OrphanPacific after completion of pricing and reimbursement processes; approval applications for the same indication are pending with the EMA and Health Canada. » Más en de.investing.com

BioCryst reported its first full year of profitability in 2025 and Q2 2026 revenue rose 33.6% to $218.25 million, supported by Orladeyo which generated $158.2 million in the quarter. The company holds $352.6 million in cash and recently added navenibart via acquisition, with pivotal readout due Q3 2027, sparking takeover speculation. Takeda tops the list of potential strategic buyers given the threat to Takhzyro, followed by AstraZeneca; private equity interest exists but is constrained by BioCryst’s negative shareholders' equity and debt obligations. Analysts remain positive with a consensus target of $20.82 and market attention will focus on navenibart data and any 13D activity. » Más en finance.yahoo.com

BioCryst Pharmaceuticals reported Q2 ORLADEYO revenue of $158.2 million, up 10% year over year, and began shipping pediatric oral-pellet prescriptions with 47 scripts by July 31. The company maintained its 2026 ORLADEYO guidance of $625 million to $645 million and raised total 2026 revenue guidance to $690 million to $715 million. BioCryst completed enrollment in the pivotal ALPHA-ORBIT navenibart trial with top-line data expected in Q3 2027, and kept BCX17725 on track for early 2026 data. Management cut 2026 non-GAAP operating-cost guidance to $420 million–$440 million after deciding to end internal drug discovery and close its Birmingham research facility, and reported more than $350 million in cash and investments. » Más en finance.yahoo.com