Pharvaris Reports €47.4 Million Third-Quarter Loss and €283 Million in Cash as HAE Filings Advance

Pharvaris reported a third-quarter loss of €47.4 million, or €0.67 per share, and held €283 million in cash and cash equivalents as of September 30, 2026, the company said in its third-quarter results. The Zug, Switzerland-based company is developing oral bradykinin B2 receptor antagonists for bradykinin-mediated angioedema, including hereditary angioedema and acquired angioedema due to C1 inhibitor deficiency.

Pharvaris NDA Review and CREAATE Timeline

The FDA is reviewing Pharvaris's New Drug Application for deucrictibant immediate-release capsules as an on-demand treatment for HAE attacks, with a PDUFA action date of April 23, 2027. The European Medicines Agency is formally reviewing the marketing authorization application for deucrictibant IR under the centralized procedure.

Topline data from part 1 of CREAATE, a pivotal Phase 3 study of deucrictibant XR for prophylaxis of AAE-C1INH attacks, are expected in the first quarter of 2027. In part 1, 24 participants were randomized to deucrictibant XR 40 mg or placebo once daily. Enrollment continues in part 2, in which participants treat two attacks in a cross-over design, one with deucrictibant IR and one with placebo.

Pharvaris said the pivotal Phase 3 CHAPTER-3 study of deucrictibant XR met its primary endpoint and all secondary efficacy endpoints with statistical significance. Treatment reduced the mean monthly attack rate by 83% (p<0.0001) across all HAE types, and by 87% in participants with HAE Type 1 or Type 2, with protection beginning in the first week and sustained through 24 weeks.

"The successful readout of the pivotal Phase 3 study of deucrictibant XR for the prophylaxis of HAE attacks was a major milestone for Pharvaris," said Berndt Modig, Chief Executive Officer of Pharvaris.

Pharvaris Cash and Prior Fundraising

According to akta.pro company records, Pharvaris priced a $175 million public offering of ordinary shares and pre-funded warrants at $20.00 per share in April 2026, extending its cash runway into 2028. The company closed a $132.3 million underwritten offering in May 2026, with Morgan Stanley, Leerink, Cantor and Wells Fargo as joint book-running managers. The same records list a €292 million cash position at the end of 2025 and a €247 million cash position in the first quarter of 2026.

Earlier Pharvaris Data and Conference Steps

Pharvaris published Phase 3 RAPIDe-3 results in The Lancet in October 2026, showing deucrictibant IR met its primary endpoint and all 11 secondary endpoints, with symptom relief in 1.28 hours and complete resolution in 11.95 hours, according to Stock Titan. The company said in October 2026 that six abstracts were accepted for the ACAAI 2026 Annual Scientific Meeting in Phoenix, including a late-breaking oral presentation on CHAPTER-3 data, FinancialContent Business Page reported. At the Guggenheim Healthcare Innovation Conference in November 2026, Pharvaris cited clinical data on rapid onset and high single-dose resolution and outlined parallel regulatory filings for hereditary and acquired angioedema, Investing.com reported.

Pharvaris Filings Planned for 2027

Pharvaris plans to submit the NDA for deucrictibant XR for prophylaxis of AE-BK attacks in the first half of 2027, with data from CHAPTER-3, CHAPTER-4 and part 1 of CREAATE as the basis. The company is scheduled to hold a fireside chat at the 9th Annual Evercore Healthcare Conference on December 2, 2026.