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StocksMedium•4 August 2026•
1 min read

FDA Accepts Pharvaris NDA for HAE Treatment Deucrictibant

Key Facts

1The FDA accepted Pharvaris's NDA for deucrictibant IR, with a PDUFA date set for April 23, 2027.
2Phase 3 CHAPTER-3 data for deucrictibant XR is expected in Q3 2026.

In a move reflecting the ongoing evolution of the biotech sector's approach to rare diseases, Pharvaris announced that the U.S. FDA has accepted its New Drug Application (NDA) for deucrictibant IR. According to reports, the agency has set a PDUFA action date for April 23, 2027. This regulatory milestone marks a significant step for the company as it seeks to provide oral treatment options for acute Hereditary Angioedema (HAE) attacks.

Pharvaris aims to establish a vertically integrated franchise for HAE treatment by developing deucrictibant in two distinct formulations. Beyond the current NDA acceptance, the company is anticipating Phase 3 CHAPTER-3 data for its XR formulation in the third quarter of 2026. These clinical and regulatory efforts follow positive results from the RAPIDe-3 trial, which underpin the company's strategy to reshape the therapeutic landscape for HAE patients.

In the broader macroeconomic environment, the Federal Reserve maintained interest rates at 3.75% as of July 29, 2026, a factor that remains critical for risk appetite within the capital-intensive biotechnology industry.