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Pharvaris Gets April 2027 FDA Decision Date for Oral HAE Therapy Deucrictibant

Pharvaris N.V. (PHVS) · Thu 12 Nov 2026

Pharvaris reported Q3 2026 results, with the FDA reviewing its NDA for on-demand deucrictibant IR and the EMA assessing the matching marketing authorisation application.

Pharvaris N.V. reported its third-quarter 2026 results on 12 November 2026. The company said the US Food and Drug Administration has set a PDUFA goal date of 23 April 2027 for its new drug application for oral deucrictibant IR. The product is intended as an on-demand treatment for attacks of hereditary angioedema (HAE).

The European Medicines Agency is also reviewing the corresponding marketing authorisation application (MAA) for the same product. The summary provided does not give a timeline for the EMA's opinion.

Looking ahead, Pharvaris expects topline data from Part 1 of its CREAATE study in acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH) in the first quarter of 2027. It also plans to file an NDA for deucrictibant XR, a prophylaxis formulation, in the first half of 2027.

On the financial side, the company reported cash of €283 million at the end of the quarter and a quarterly net loss of €47.4 million.

For context, a PDUFA date is the target date by which the FDA aims to complete its review of an application. It is a goal rather than a guarantee of approval.

What it means for your team

  • Regulatory teams tracking HAE should note the 23 April 2027 PDUFA date for oral on-demand deucrictibant IR, with a parallel EMA review under way.
  • Market-access teams may need to follow the 2027 sequence of CREAATE Part 1 data and the planned XR prophylaxis NDA, as these could widen the oral HAE options.
  • Pharmacovigilance and quality teams should watch for any FDA or EMA questions during review, though none are mentioned in the company's summary.

Company's press release (SEC filing): Pharvaris N.V. ↗

Article written by VigiEye from the official source (Pharvaris N.V.). Claims are the company's own. AI-assisted; check the source before acting.

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