Pharvaris Aktie

Pharvaris unveiled final plans for Deucrictibant at the Morgan Stanley Healthcare Conference. The oral HAE drug showed Phase‑III efficacy of 87% in HAE types 1 and 2 (83% in the extended population). The company is targeting U.S. approval for on‑demand treatment with a PDUFA target date of April 2027 and is preparing a prophylactic indication thereafter. Management highlighted a favorable safety profile versus competing oral therapies, plans to build a commercial organization (target: ~90 employees) and expects liquidity into mid‑2028 in the base case. Additional data from CREATE and an open‑label extension study are expected to be released in the coming months. » Más en de.investing.com

At the Cantor Fitzgerald conference Pharvaris presented phase‑III data (CHAPTER‑3) showing an 87% reduction in hereditary angioedema attacks with the oral B2‑receptor antagonist Deucrictibant. The study included patients from six continents and used an extended‑release formulation that may explain the improved efficacy profile. Safety questions remain: two grade‑3 elevations in liver enzymes and one serious laryngeal event were reported, though the company considers the overall profile comparable to existing prophylactics. Pharvaris plans to launch the on‑demand treatment on April 8, 2025, and aims to file for approval for prophylaxis in the first half of 2025, supported by a targeted commercial platform for bradykinin‑mediated angioedemas. » Más en de.investing.com

Deucrictibant reduced HAE attacks by 87% in the phase‑III prophylaxis study in type‑1/ type‑2 patients (83% in the overall population) and replicated earlier results in a larger, global cohort. Pharvaris expects a PDUFA date for the on‑demand formulation on April 23 and plans to submit the regulatory application for the prophylaxis version in H1 2025. Two cases of elevated liver enzymes were reported but, according to management, are comparable to known risks; long‑term safety is being investigated in the open‑label extension study CHAPTER‑4. Commercially, the company intends to target treatment‑naive patients as well as users of ORLADEYO and injectable therapies. » Más en de.investing.com