Pharvaris Earnings Call Transcripts
Fiscal Year 2026
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Strong RAPIDe-3 data supports NDA filing for acute HAE in H1, with prophy trial readout expected in Q3. Oral deucrictibant offers rapid symptom relief and unique flexibility for both on-demand and prophylactic use, positioning it well in a dynamic, growing market.
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The company is advancing oral therapies for hereditary and acquired angioedema, with strong phase III data for on-demand treatment and promising phase II results for prophylaxis. NDA filings and launches are planned, supported by a robust cash position and commercial infrastructure.
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The company is advancing an oral therapy for HAE, with phase III data showing rapid, robust efficacy in on-demand use and promising results in prophylaxis. NDA filing is planned for the first half of the year, with a strong cash runway and multiple data presentations at AAAAI.
Fiscal Year 2025
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RAPIDe-3 phase III results show deucrictibant immediate release capsule achieved rapid and durable symptom relief for HAE attacks, meeting all primary and secondary endpoints with a favorable safety profile. The study included a diverse, global population and all HAE subtypes, supporting broad applicability and strong patient interest in oral therapy.
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Deucrictibant aims to address unmet needs in hereditary angioedema with oral, highly efficacious, and well-tolerated formulations for both on-demand and prophylactic use. Phase 3 trials are progressing ahead of schedule, with strong financial positioning and plans for label expansion into broader angioedema indications.
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Two pivotal Phase 3 studies for deucrictibant in hereditary angioedema are expected to read out by 2026, with a Phase 3 in acquired angioedema starting this year. Phase II data show rapid symptom relief and strong attack reduction, supporting a dual oral formulation strategy for both on-demand and prophylactic use.
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Phase 3 data for two oral HAE therapies are expected by end of 2024 and 2026, targeting both on-demand and prophylactic markets. Oral options are poised to capture significant share from injectables, with a focus on efficacy, convenience, and a broader label. U.S. launch is prioritized, with ex-U.S. partnerships under consideration.
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Deucrictibant is positioned as a leading oral therapy for both on-demand and prophylactic use in bradykinin-mediated angioedema, with pivotal data expected in Q4 and a US launch targeted for early 2027. The company is expanding its clinical program and commercial preparations, aiming for broad market impact and differentiation through unique B2 receptor targeting.
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Deucrictibant is advancing in Phase 3 for both on-demand and prophylactic HAE treatment, aiming to combine oral convenience with injectable-level efficacy. Recent Phase 2 data showed strong attack reduction, and global Phase 3 trials are underway, with key data readouts expected in 2026.
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Significant unmet needs exist in bradykinin-mediated angioedema, especially for subtypes beyond HAE types 1 and 2. Deucrictibant is being studied in pivotal phase III trials for both prophylactic and on-demand use, with promising early data and a novel biomarker assay supporting patient identification and trial design.
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The presentation highlighted late-stage development of an oral B2 receptor antagonist for both prophylactic and on-demand treatment of hereditary angioedema, with strong phase 2 efficacy data and phase 3 results expected in 2026. Plans include label expansion and market leadership in Bradykinin-mediated angioedema.
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Barbarus presented strong Phase II data for ducrictovant, an oral B2 receptor antagonist for HAE, showing rapid, durable efficacy and a favorable safety profile. Phase III trials in both acute and prophylactic settings are underway, with key data readouts expected in early 2026.
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Two phase III trials are underway for oral on-demand and prophylactic therapies, with pivotal data expected in 2026. The company is uniquely positioned to offer both options, addressing unmet needs in efficacy, safety, and convenience, and is planning a compact, focused commercialization strategy.
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Oral deucrictibant shows injectable-like efficacy in HAE, with phase III readouts expected in 2026. The company is well-funded through key milestones and expanding into acquired angioedema, targeting both on-demand and prophylactic markets.
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Deucrictibant, an oral therapy for hereditary angioedema, showed strong efficacy and safety in phase II trials for both prophylaxis and on-demand use. Two pivotal phase III trials are ongoing, with top-line data expected in 2026, and the market is shifting toward more convenient, patient-friendly options.
Fiscal Year 2024
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Deucrictibant, an oral B2 receptor antagonist, is advancing in phase 3 trials for both HAE prophylaxis and on-demand treatment, with strong phase 2 efficacy and safety data. The company is well-funded, targeting market growth, and planning expansion into related indications.
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The company is advancing two oral therapies for hereditary angioedema, targeting both on-demand and prophylactic use, with global phase III trials underway. The market is rapidly growing, especially in the U.S., and the new oral therapy aims to combine efficacy and convenience for personalized patient needs.
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Significant unmet needs remain in HAE, especially for convenient, effective oral therapies. Deucrictibant shows promise as both an on-demand and prophylactic oral option, with strong efficacy and tolerability data. Patient and physician preferences are shifting toward oral treatments with injectable-like efficacy.
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Deucrictibant, an oral B2 receptor antagonist, demonstrated strong efficacy and safety in both prophylactic and on-demand HAE treatment, with long-term data showing high attack reduction and low treatment burden. Phase III trials are underway, and expansion into acquired angioedema is planned.