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

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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