Pharvaris Reports Positive Phase 3 Results for Deucrictibant IR, Plans H1 2026 NDA Submission, and Secures €160M Financing

summarizeSummary

Pharvaris N.V. reported positive pivotal Phase 3 results for its on-demand HAE treatment, Deucrictibant IR, with an NDA submission planned for H1 2026, alongside a successful €160.3 million financing round and ongoing progress in its prophylactic and AAE clinical programs.

check_boxKey Events

• Positive Phase 3 Results for Deucrictibant IR

  The RAPIDe-3 pivotal Phase 3 study for Deucrictibant IR capsules in on-demand HAE treatment met its primary and all 11 key secondary efficacy endpoints with statistical significance, demonstrating rapid and sustained symptom relief.

• Planned NDA Submission in H1 2026

  Following the successful RAPIDe-3 results, Pharvaris N.V. plans to submit a New Drug Application (NDA) to the U.S. FDA in the first half of 2026 for Deucrictibant IR.

• Successful €160.3 Million Equity Financing

  In July 2025, the company completed an underwritten offering of ordinary shares and pre-funded warrants, generating net proceeds of €160.3 million (approximately $188.5 million).

• Strong Cash Position and Runway

  As of December 31, 2025, Pharvaris held €291.7 million in cash and cash equivalents, which management believes is sufficient to fund operations for at least twelve months.

auto_awesomeAnalysis

Pharvaris N.V.'s annual report highlights significant progress in its clinical pipeline and a strengthened financial position. The company announced positive pivotal Phase 3 results for Deucrictibant IR capsules for on-demand treatment of HAE attacks, meeting all primary and key secondary efficacy endpoints with statistical significance. This success paves the way for a New Drug Application (NDA) submission to the FDA in the first half of 2026, a critical de-risking event for their lead candidate. Additionally, Pharvaris successfully completed a substantial underwritten offering in July 2025, raising €160.3 million (approximately $188.5 million) in net proceeds, which significantly bolsters its cash reserves to €291.7 million as of December 31, 2025. This financing, representing a substantial portion of the company's market capitalization, provides a runway of at least twelve months to fund ongoing operations and advance its clinical programs. The company also continues to progress its prophylactic (CHAPTER-3) and acquired angioedema (CREAATE) Phase 3 studies. While the net loss increased to €175.7 million in 2025, this is typical for a clinical-stage biopharmaceutical company heavily investing in R&D. The positive clinical data and robust financing are strong indicators of the company's advancement towards commercialization.