ZACKS·2025-12-04 19:11Core Insights - Pharvaris (PHVS) shares increased nearly 22% following positive results from the phase III RAPIDe-3 study for its drug deucrictibant, aimed at treating hereditary angioedema (HAE) attacks in adults and adolescents aged 12 and older [2][8] Study Results - The RAPIDe-3 study achieved its primary endpoint, with patients experiencing symptom relief within 1.28 hours after taking deucrictibant, compared to over 12 hours with placebo [3] - All secondary endpoints were met, including a median time to substantial symptom relief of under 3 hours with deucrictibant versus over 12 hours with placebo, and complete symptom resolution in 11.95 hours compared to more than 24 hours for placebo [3] - 83% of HAE attacks were managed with a single dose of deucrictibant, and over 93% of attacks were treated without the need for backup treatment [4] Regulatory Plans - Pharvaris plans to submit a regulatory filing for deucrictibant in the first half of 2026, which could position it as the second oral on-demand therapy for HAE after KalVista Pharmaceuticals' Ekterly [5] Competitive Landscape - Comparisons between deucrictibant and KalVista's Ekterly highlight potential advantages for deucrictibant, as it showed faster symptom relief in the RAPIDe-3 study compared to the KONFIDENT study supporting Ekterly's approval [6] - Year-to-date, Pharvaris stock has risen 53%, outperforming the industry growth of 20% [7] Product Development - Pharvaris is developing two formulations of deucrictibant: an immediate-release capsule for acute treatment and an extended-release tablet for prophylactic treatment [10] - The extended-release tablet is being evaluated in the phase III CHAPTER-3 study for HAE prophylaxis, with top-line data expected in the second half of 2026 [11] - Additionally, the extended-release formulation is under evaluation in the CREAATE study for treating acquired angioedema with C1-inhibitor deficiency [12] Market Positioning - If approved, deucrictibant will compete in the on-demand treatment space against KalVista's Ekterly, with advantages over older injectable treatments like Firazyr and Kalbitor due to its oral administration [14] - In the prophylactic treatment segment, competitors include BioCryst Pharmaceuticals and Ionis Pharmaceuticals, with BioCryst's Orladeyo and Ionis' Dawnzera being notable products [15]