Pharvaris prepares for first FDA submission following success in HAE trials

Pharvaris (NASDAQ:PHVS) is moving toward its first regulatory filing in the first half of 2026, supported by a strong cash position and pivotal clinical successes for its lead candidate, deucrictibant.

The Zug, Switzerland-based biopharmaceutical company, which specializes in oral therapies for bradykinin-mediated diseases, confirmed it remains on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the immediate-release (IR) formulation of deucrictibant.

This submission for the on-demand treatment of hereditary angioedema (HAE) attacks is backed by the successful RAPIDe-3 trial, which met its primary and all 11 secondary endpoints.

Data from RAPIDe-3 showed a median time to symptom relief of 1.28 hours, significantly outperforming placebo.

The company also reached a major operational milestone with the completion of enrollment for CHAPTER-3, a pivotal Phase 3 study evaluating deucrictibant’s extended-release (XR) formulation for the prophylactic prevention of HAE attacks.

Topline data from this trial is anticipated in the third quarter of 2026.

Financially, Pharvaris ended the fiscal year on Dec. 31, 2025, with a robust liquidity position of €292 million ($318 million) in cash and cash equivalents.

Despite a full-year net loss of €175.7 million—driven by increased research and development expenses as trials entered late stages—the company’s current capital is expected to fund operations and regulatory preparations well into 2027.