Pharvaris' latest phase 3 win builds case for HAE drug with FDA verdict pending

Biotech Pharvaris' latest phase 3 win builds case for HAE drug with FDA verdict pending By James Waldron Sep 8, 2026 10:10am Pharvaris hereditary angioedema genetic diseases Clinical Data Pharvaris’ deucrictibant has tasted success in a second phase 3 study, strengthening the case for the therapy to treat hereditary angioedema (HAE) patients as the Swiss biotech awaits an FDA approval decision. The biotech has been evaluating a 40-mg once-daily extended-release formulation of its oral bradykinin B2 receptor antagonist against placebo in the late-stage CHAPTER-3 study. The trial enrolled 85 patients with three types of HAE: HAE type 1, HAE type 2 or HAE with normal C1 inhibitor.

The study hit its primary endpoint by demonstrating an 83% reduction in the rate of monthly attacks compared with placebo after 24 weeks, Pharvaris reported in a Sept. 8 release. This reduction was boosted to 87% when looking specifically at the 80 patients with HAE type 1 or 2, the Swiss biotech noted.

Deucrictibant also aced all of the secondary endpoints (PDF), according to Pharvaris, including the number of attacks treated with on-demand medication, the number of severe attacks and the proportion of time without angioedema symptoms. The Zug, Switzerland-based company filed an immediate-release formulation of deucrictibant for FDA approval in July to treat HAE attacks, with the agency setting an April 23, 2027, decision date. If approved, deucrictibant will give HAE patients an alternative to KalVista’s Ekterly, an existing oral HAE attack treatment.

That approval submission followed a separate phase 3 win for immediate-release deucrictibant in December 2025, when the drug demonstrated its potential as an on-demand treatment for episodes of swelling and related symptoms that affect people with HAE. The company also plans to submit an NDA for deucrictibant as a prophylactic for bradykinin-mediated angioedema attacks in the first half of 2027. Related Pharvaris clocks a pivotal win in race for rapid HAE relief, teeing up filing to challenge KalVista Pharvaris CEO Berndt Modig said this morning’s readout represented a “landmark moment for the company and the community as a whole.” “Deucrictibant could be the first and only oral therapy to offer injectable-like efficacy and a well-tolerated profile in on-demand treatment and prophylaxis with our two unique formulations,” Modig explained.

“Pharvaris now plans to redefine disease management by uniting on-demand treatment and long-term prophylaxis within a single therapeutic franchise.” Pharvaris’ stock was trading up 14% at $41.44 after markets opened, compared with a $35.25 closing price on Friday. HAE is a rare genetic condition that causes recurrent, unpredictable and potentially life-threatening swelling of the face, limbs, gastrointestinal tract and airways. Intellia has its own HAE option in the works courtesy of the in vivo gene-editing therapy lonvoguran ziclumeran, which also saw phase 3 success earlier this year.

Pharvaris hereditary angioedema genetic diseases Clinical Data Biotech