Pharvaris N.V. reported that its Phase 3 RAPIDe‑3 study met all 11 prespecified endpoints, enrolling 134 patients across 24 countries and including adolescents and adults with all hereditary angioedema (HAE) subtypes. The oral immediate‑release (IR) capsule of deucrictibant produced a median time to substantial symptom relief of 1.28 hours versus 3.12 hours for placebo, and a median time to complete symptom resolution of 11.95 hours versus 20.12 hours for placebo. Fewer patients required a second dose or rescue medication within 12 hours, and no treatment‑related serious adverse events or discontinuations were reported.
The data de‑risk the company’s lead product and provide a clear regulatory pathway. Pharvaris plans to file marketing‑authorization applications in the first half of 2026, leveraging the orphan‑drug designation it holds in the U.S., Europe, and Switzerland. If approved, deucrictibant would be the first oral therapy capable of both on‑demand and prophylactic HAE treatment, offering “injectable‑like efficacy and placebo‑like tolerability” in a single capsule.
The global HAE therapeutics market is projected to reach USD 12.79 billion by 2030, driven by a growing patient population and limited treatment options. Oral convenience is a significant competitive advantage, as current therapies are predominantly injectable. Pharvaris’s oral formulation could capture a sizable share of this expanding market, especially if it secures regulatory approval ahead of emerging gene‑therapy candidates.
Pharvaris’s Q3 2025 financials show a net loss of €37.1 million, an improvement from €41.7 million in Q3 2024, and a loss per share of €0.60 versus €0.77 a year earlier. Research and development expenses rose to €29.8 million from €25.8 million, reflecting the company’s investment in the Phase 3 program. With a cash balance of €329 million and no product revenue yet, the company’s financial position is typical for a late‑stage biopharma focused on a single candidate.
CEO Berndt Modig said, “The RAPIDe‑3 data will serve as the basis for marketing‑authorization applications, which are planned to be filed starting in the first half of 2026.” Chief Medical Officer Peng Lu added, “These clinically meaningful and statistically significant results demonstrate deucrictibant’s early‑onset response, fast symptom relief and resolution, and a well‑tolerated safety profile.”
Investors reacted positively to the announcement, reflecting confidence that the Phase 3 success de‑risks the product and accelerates the regulatory timeline. The company’s strong cash runway and orphan‑drug status further support a favorable outlook.
Headwinds include competition from existing injectable and oral HAE therapies and the potential emergence of gene‑therapy solutions. Tailwinds are the oral convenience of deucrictibant, its orphan‑drug designation, and a robust cash position that provides runway into the first half of 2027.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.