Pharvaris Aktie

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. » Więcej na 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. » Więcej na de.investing.com

Pharvaris reported statistically significant topline results from the pivotal phase‑3 study CHAPTER‑3: Deucrictibant XR reduced the mean monthly HAE attack rate by 83% versus placebo (p<0.0001) and lowered the rate in HAE type 1/2 by 87%. All secondary endpoints were significant and the safety profile proved well tolerated. The company intends to use the data for regulatory submissions, including a New Drug Application in the US in the first half of 2027, and the stock then reached a new 52‑week high. » Więcej na de.investing.com