Pharvaris N.V. and Deucrictibant: Pioneering a Dual-Action Oral Therapy in the High-Growth HAE Market

The rare disease sector has long been a magnet for innovation, and hereditary angioedema (HAE) is no exception. With a global market projected to grow at a 9.6% compound annual rate to $5.96 billion by 2032, the stakes are high for companies developing therapies that address unmet needs. Among the most compelling stories in this space is Pharvaris N.V. (NASDAQ: PHVS), whose lead candidate, deucrictibant, is advancing through pivotal Phase 3 trials as a dual-action oral therapy for HAE. This article evaluates the clinical and commercial potential of deucrictibant, assessing whether Pharvaris can disrupt a market dominated by injectables and position itself as a leader in the evolving HAE treatment landscape.

Clinical Potential: A Dual-Action Approach with Strong Phase 2 Backing

Deucrictibant is a bradykinin B2 receptor antagonist designed to block the inflammatory cascade that drives HAE attacks. Its dual formulation—extended-release (XR) for prophylaxis and immediate-release (IR) for on-demand use—addresses two critical gaps in the current HAE treatment paradigm.

In Phase 2 trials, the XR formulation demonstrated sustained efficacy over 1.5 years, with attack rates reduced by up to 90% in participants, regardless of baseline severity. Quality of life (HRQoL) metrics improved significantly, and the safety profile remained favorable, with no major adverse events reported. For on-demand use, the IR formulation showed rapid relief, with 97.8% of attacks resolving within 12 hours and 86.9% resolving fully by 24 hours. These results, presented at the 2025 EAACI Congress and US HAE Summit, underscore deucrictibant's potential to become a one-stop solution for HAE patients.

The Phase 3 CHAPTER-3 and RAPIDe-3 trials are now enrolling, with topline data expected in mid-2026. Notably, RAPIDe-3 is the first Phase 3 on-demand study to test the “end-of-progression” endpoint, a metric that could redefine how HAE attack resolution is measured. Regulatory milestones, including TQT study waivers from the FDA, further streamline the path to approval.

Commercial Potential: Capturing a Growing Market with Oral Convenience

The HAE market is ripe for disruption. While injectables like CSL Behring's Cinryze and Takeda's Firazyr dominate today, their delivery methods are cumbersome and often poorly tolerated, especially in pediatric populations. Deucrictibant's oral formulation offers a compelling alternative, aligning with the industry's shift toward patient-centric therapies.

The market opportunity is substantial. By 2032, the HAE market is forecasted to exceed $5.96 billion, driven by rising diagnostic rates and a growing emphasis on prophylactic treatments. Pharvaris is strategically targeting underserved segments:
1. AAE-C1INH: A rare, currently untreatable form of angioedema.
2. Pediatric and adolescent patients: Where injectables are often impractical.
3. On-demand users: Who prefer the flexibility of an oral therapy.

With orphan drug designations in the U.S. and EU, deucrictibant is poised to benefit from 10 years of market exclusivity. Analysts estimate that if approved, the drug could capture a 20-30% market share in the U.S. alone, translating to peak annual sales of $1.5–2.5 billion.

Financial Position and Market Strategy

Pharvaris has positioned itself as a well-capitalized contender. A $175 million equity raise in 2025 has extended its runway through Q3 2026, providing flexibility to advance trials and build a U.S. commercial infrastructure. The company's IP portfolio, including proprietary formulations and biomarker assays, adds long-term value.

Institutional support is also growing. JPMorgan, Cubist Systematic Strategies, and KLP have increased stakes in Pharvaris, reflecting confidence in its pipeline. Analysts at Guggenheim, Wedbush, and Cantor Fitzgerald have set average price targets of $36.20, with a “Buy” consensus.

Investment Considerations: Risks and Rewards

While deucrictibant's potential is undeniable, risks remain. Regulatory delays in Phase 3 trials could push approval timelines, and post-approval competition from emerging therapies like sebetralstat (KalVista) and donidalorsen (Ionis) could erode market share. Additionally, pricing pressures in markets with strict reimbursement policies may limit margins.

However, Pharvaris' dual formulation and first-mover advantage in on-demand oral therapy create a durable moat. The company's focus on patient-reported outcomes and extended-release formulations also align with payer preferences for cost-effective, long-term solutions.

Conclusion: A High-Conviction Play in a High-Growth Sector

Pharvaris represents a rare intersection of clinical innovation and commercial opportunity. Deucrictibant's dual-action profile, supported by robust Phase 2 data and a streamlined regulatory path, positions it to redefine HAE treatment. With the HAE market expanding rapidly and a strong balance sheet in place, the company is well-positioned to deliver shareholder value.

For investors, the key inflection points are the Q1 2026 readout from RAPIDe-3 and the H2 2026 data from CHAPTER-3. Success in these trials could catalyze a re-rating of Pharvaris' valuation, particularly as the company prepares for U.S. commercialization. While the path is not without risk, the potential rewards for a company solving a significant unmet need in a high-growth market are substantial.

Investment Recommendation: Buy with a long-term horizon, contingent on positive Phase 3 results and successful regulatory filings.