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BioCryst Achieves Reimbursement for ORLADEYO Across all Major European Countries
Globenewswire· 2025-06-06 11:00
ORLADEYO® (berotralstat) now reimbursed in the NetherlandsRESEARCH TRIANGLE PARK, N.C., June 06, 2025 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that, following a positive recommendation from the Zorginstituut Nederland, ORLADEYO® (berotralstat) has been approved for the routine prevention of hereditary angioedema (HAE) attacks in patients aged 12 years and older. This reimbursement approval in the Netherlands marks national reimbursement for ORLADEYO across all major ...
Astria Therapeutics (ATXS) 2025 Conference Transcript
2025-06-04 18:27
Summary of Astria Therapeutics Conference Call Company Overview - **Company**: Astria Therapeutics (ATXS) - **Focus**: Development of first-choice products for patients with allergic and immunologic diseases, emphasizing competitive efficacy, safety, and low treatment burden [1] Key Product Insights - **Lead Product**: Nivenabart, a monoclonal antibody targeting plasmacallicrin, currently in Phase III trials for hereditary angioedema (HAE) [1][2] - **Efficacy Data**: Nivenabart demonstrated over 90% reduction in attack rates in proof of concept trials, with potential for dosing every six months [2][10] - **Secondary Program**: STAR310, an OX40 receptor antagonist, with Phase I data expected later in the year [2] Clinical Trial Design and Expectations - **Phase III Trial**: Includes both Q3 and Q6 month dosing regimens, initiated in February 2025, with a focus on providing options for patients and physicians [16][20] - **Enrollment**: Positive enthusiasm from patients and physicians, with expectations for top-line data in early 2027 [20] - **Regulatory Strategy**: Data from the Alpha Solar trial will support FDA filing but is not critical for the pivotal trial [12][21] Market Opportunity - **HAE Market Size**: Expected to grow to approximately $5.4 billion by 2030, driven by earlier diagnoses and increased prophylactic therapy [13][14] - **Market Positioning**: Nivenabart is positioned to capture significant market share from existing therapies, particularly TEKHZYRO, due to its competitive profile and dosing convenience [15][25] Competitive Landscape - **Atopic Dermatitis**: STAR310 targets a significant unmet need in a growing market, particularly for patients inadequately controlled by existing therapies like Dupixent [29][30] - **Differentiation Strategy**: STAR310 aims to provide efficacy without the adverse effects associated with T cell killing, which is a concern with other therapies [33][34] Financial Position and Future Catalysts - **Cash Position**: Approximately $300 million, expected to sustain operations into mid-2027 [38] - **Upcoming Catalysts**: Key data releases include long-term safety and efficacy from the Alpha Solar trial and Phase I data for STAR310, with a focus on differentiating factors [38][39] Additional Insights - **Physician Feedback**: Physicians are interested in both dosing regimens for Nivenabart, indicating a potential for flexible treatment options based on patient needs [18][19] - **Market Research**: Indications show strong interest in Nivenabart's profile, suggesting a favorable reception among physicians for switching from existing therapies [25][26] This summary encapsulates the critical points discussed during the Astria Therapeutics conference call, highlighting the company's strategic focus, product pipeline, market opportunities, and financial outlook.