Pharvaris Shares Surge on Positive HAE Drug Trial Results
Pivotal Phase 3 study for its oral drug deucrictibant met all primary and secondary endpoints, setting the stage for regulatory submissions in 2026.
Pharvaris BV (NASDAQ: PHVS) saw its shares climb in Wednesday trading after the clinical-stage biopharmaceutical company announced positive topline results from a pivotal Phase 3 study of its experimental oral drug, deucrictibant, for the on-demand treatment of hereditary angioedema (HAE) attacks.
The company's stock, which has a 52-week high of $28.63, experienced significant volume following the news. The results position Pharvaris to challenge existing treatments in the competitive market for HAE, a rare and potentially life-threatening genetic disorder characterized by severe swelling.
The RAPIDe-3 pivotal study met its primary endpoint with high statistical significance. According to the company's announcement, patients treated with deucrictibant experienced a median time to the onset of symptom relief of just 1.28 hours, compared to more than 12 hours for those on placebo (p<0.0001). This rapid action is a critical factor for patients seeking immediate relief from painful and debilitating HAE attacks.
Beyond the primary endpoint, the study was a comprehensive success, meeting all 11 of its secondary efficacy endpoints. Pharvaris reported that the drug was well-tolerated, with a safety profile comparable to placebo, a key consideration for both patients and regulators.
"These robust data confirm the potential of deucrictibant to provide a highly effective, rapid, and reliable oral therapy for the on-demand treatment of HAE attacks," said Berndt Modig, Chief Executive Officer of Pharvaris, in the press release. "We are confident that deucrictibant can become a leading choice for people with HAE."
The positive outcome provides Pharvaris with a clear path forward for regulatory approval. The company stated it plans to begin submitting marketing applications to global regulatory authorities in the first half of 2026. If approved, deucrictibant would enter a market with established players but also a significant demand for more convenient, effective oral treatments.
The current HAE treatment landscape includes injectable therapies like Takeda's Firazyr and BioCryst Pharmaceuticals' oral prophylactic drug, Orladeyo. Deucrictibant's strong efficacy and oral on-demand profile could make it a strong competitor, particularly against KalVista Pharmaceuticals' sebetralstat, another oral on-demand therapy in development.
Prior to the data release, Wall Street analysts were largely bullish on Pharvaris's prospects. The company holds a strong consensus 'Buy' rating, with 10 of 11 analysts covering the stock rating it as a 'Buy' or 'Strong Buy'. The average analyst price target sits at $37.79, suggesting considerable upside from its current trading level. The successful Phase 3 readout was a widely anticipated catalyst that analysts believed was a de-risking event for the company.
With a market capitalization of approximately $1.69 billion and a strong institutional ownership of over 96%, Pharvaris has been closely watched by investors specializing in the biotech sector. The successful completion of the RAPIDe-3 study is a landmark achievement for the Netherlands-based company, validating its scientific platform and significantly advancing its lead asset toward commercialization.