Pharvaris Shares Surges On Positive Data From HAE Attacks Study, Makes Way For FDA To Remove Clinical Hold

  • Pharvaris NV PHVS announced topline data from the RAPIDe-1 Phase 2 study, demonstrating statistically significant results of PHVS416 as an oral on-demand treatment for hereditary angioedema (HAE) attacks. 
  • The study's primary endpoint is the change of a three-symptom composite (skin pain, skin swelling, abdominal pain) visual analog scale (VAS-3) score from pre-treatment to four hours post-treatment.
  • Topline data from 147 attacks collected by 62 patients show that dose levels of PHVS416 significantly reduce attack symptoms.
  • All key secondary endpoints of the study were met, demonstrating that PHVS416 significantly Shortens the time to onset of symptom relief by a ≥30% reduction in VAS-3 score from the pre-treatment score.
  • PHVS416 was generally well tolerated, with no treatment-related serious adverse events and no adverse events leading to treatment discontinuation.
  • In August, the FDA placed clinical studies of PHA121, including RAPIDe-1 and CHAPTER-1, on hold
  • After the clinical holds, the company continues to evaluate PHVS416 for acute attacks for continuing participants enrolled outside the U.S.
  • Topline data from CHAPTER-1 Phase 2 study of PHVS416, anticipated 2H2023.
  • The company ended Q3 with a cash balance of €209 million.
  • Price Action: PHVS shares are up 220.70% at $8.45 on the last check Thursday.
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