Hereditary angioedema treatment
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KalVista Details Early Sales, Prescriber Uptake For Newly Approved Rare Swelling Drug
Benzinga· 2026-01-09 14:56
Core Insights - KalVista Pharmaceuticals reported early commercial momentum for its hereditary angioedema treatment EKTERLY, with increasing prescriber adoption and repeat prescriptions following its mid-2025 launch [1] Group 1: Product Launch and Market Performance - EKTERLY received FDA approval in July 2025 as the first and only oral on-demand treatment for acute attacks of hereditary angioedema in patients aged 12 and older [2] - The company disclosed preliminary net product revenue of approximately $35 million for Q4 and $49 million for fiscal year 2025, following the commercial launch in July 2025 [3] - Prescription refills have overtaken new prescriptions as the primary revenue driver, indicating growing continuity of use among patients [4] Group 2: Expansion and Future Plans - KalVista has granted Multicare Pharmaceuticals exclusive rights to commercialize sebetralstat in Latin America, overseeing regulatory approvals and distribution in Brazil, Argentina, Colombia, and Mexico [4][5] - The company completed enrollment in the Phase 3 KONFIDENT-KID trial for children aged 2 to 11 with hereditary angioedema, finishing a year ahead of schedule, with plans to submit a new drug application in Q3 2026 [5] Group 3: Stock Performance - KalVista Pharmaceuticals stock increased by 13.18%, reaching $17.86 at the time of publication [6]
BioCryst Achieves Reimbursement for ORLADEYO Across all Major European Countries
Globenewswire· 2025-06-06 11:00
Core Insights - BioCryst Pharmaceuticals has secured reimbursement approval for ORLADEYO (berotralstat) in the Netherlands, enabling routine prevention of hereditary angioedema (HAE) attacks for patients aged 12 and older [1][2] - This approval signifies national reimbursement for ORLADEYO across all major European countries, enhancing access to the first oral, once-daily preventive therapy for HAE patients [1][3] Company Overview - BioCryst Pharmaceuticals is a global biotechnology company focused on improving the lives of individuals with hereditary angioedema and other rare diseases, utilizing expertise in structure-guided drug design [11] - The company has commercialized ORLADEYO, the first oral, once-daily plasma kallikrein inhibitor, and is advancing a pipeline of small-molecule and protein therapies [11] Product Information - ORLADEYO is indicated for the prophylaxis of hereditary angioedema attacks in adults and pediatric patients aged 12 years and older, with one capsule taken daily to reduce plasma kallikrein activity [4][5] - The safety and effectiveness of ORLADEYO for treating acute HAE attacks have not been established, and it is not recommended for such use [6][10]