Pharvaris' Deucrictibant Achieves Pivotal Success in HAE Treatment, Challenging KalVista's Market Position

Pharvaris has announced a significant breakthrough in the treatment of hereditary angioedema (HAE), with its oral medication deucrictibant demonstrating impressive results in a phase 3 clinical trial. This development positions the biotech company to file for regulatory approval and potentially challenge KalVista Pharmaceuticals' Ekterly in the market for rapid HAE relief.

Phase 3 Trial Results Showcase Deucrictibant's Efficacy

The phase 3 trial, involving 134 HAE patients, revealed that deucrictibant substantially outperformed the placebo in providing symptom relief. Patients receiving the drug experienced relief in just 1.28 hours, compared to over 12 hours for those on placebo. This primary endpoint result aligns closely with analyst expectations and demonstrates deucrictibant's potential as a fast-acting treatment for HAE attacks.

Key findings from the trial include:

• Time to substantial symptom relief by PGI-S: 2.41 hours
• Time to complete symptom resolution: 11.95 hours
• Single-dose efficacy: 83% of attacks resolved

The safety profile of deucrictibant was also favorable, with no treatment-related serious adverse events reported and no discontinuations due to treatment-emergent adverse events.

Market Implications and Competitive Landscape

Pharvaris CEO Berndt Modig emphasized the drug's potential to offer "beginning-to-end control of HAE attack treatment." This positioning sets the stage for a competitive entry into the market currently dominated by KalVista's Ekterly.

Comparative data suggest that deucrictibant may have an edge over Ekterly in certain aspects:

• Deucrictibant: Symptom relief in 1.28 hours
• Ekterly: Symptom relief in 1.61 hours (based on previous phase 3 trial data)

Financial analysts from Guggenheim Securities project a potential peak market penetration of up to 66% for deucrictibant in the on-demand setting, with estimated peak annual revenue reaching $800 million.

Regulatory Timeline and Future Prospects

Pharvaris plans to file for regulatory approval of deucrictibant in the first half of 2026. If approved, it will provide HAE patients with a new oral option for managing acute attacks.

The success of deucrictibant in this pivotal trial has already impacted Pharvaris' market position, with the company's stock price increasing by 10% to $26.50 in premarket trading following the announcement.

As the pharmaceutical landscape for HAE treatment continues to evolve, the introduction of deucrictibant could significantly alter patient care strategies and market dynamics in this rare disease space.