RegulatoryAug 12, 2026, 06:51 AM
Pharvaris Deucrictibant IR FDA PDUFA April 2027; Phase 3 data 3Q26
AI Summary
Pharvaris announced its Q2 2026 financial results and business updates, highlighting significant progress in its deucrictibant development program. The FDA accepted the New Drug Application for deucrictibant IR with a PDUFA date of April 23, 2027, and the EMA validated its Marketing Authorization Application. The company also expects topline data from its pivotal CHAPTER-3 Phase 3 study in 3Q2026 and reported a strong cash position of €318 million.
Key Highlights
- Deucrictibant IR NDA accepted by FDA with PDUFA date of April 23, 2027.
- Deucrictibant IR MAA validated by EMA in July 2026.
- Topline data from CHAPTER-3 Phase 3 study expected in 3Q2026.
- Cash and cash equivalents were €318 million as of June 30, 2026.
- Q2 2026 net loss was €47.8 million (€0.70 per share).
- R&D expenses increased to €35.0 million in Q2 2026 from €29.6 million in Q2 2025.
- Peng Lu promoted to President, effective June 2026.
- Completed $132 million underwritten offering, extending cash runway into 2028.
Price Impact
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