PHVS Deucrictibant NDA Accepted: First Oral HAE Therapy

Pharvaris (PHVS) announced on July 6, 2026 that the FDA accepted its New Drug Application (NDA) for deucrictibant immediate-release (IR) capsules for on-demand treatment of hereditary angioedema (HAE) attacks. The FDA set a PDUFA target action date of April 23, 2027, with Priority Review.

What deucrictibant does

Deucrictibant is an oral small-molecule bradykinin B2 receptor antagonist. HAE attacks are driven by excess bradykinin signaling, which causes rapid swelling of the skin, gastrointestinal tract, and airway that can be fatal. Icatibant (Takeda’s Firazyr), an injectable bradykinin B2 receptor antagonist, is the current standard for on-demand treatment. Deucrictibant targets the same receptor but is orally bioavailable, which would eliminate the injection burden for patients managing acute attacks.

The NDA is supported by RAPIDe-3 (NCT06343779), a global, placebo-controlled Phase 3 study enrolling patients age 12 and older with HAE, including the normal C1 inhibitor subtype. The trial met its primary endpoint and all 11 secondary efficacy endpoints with statistical significance.

The efficacy numbers

Across the development program, deucrictibant IR has been evaluated in over 1,300 HAE attacks. In RAPIDe-3, the median time to onset of symptom relief was 1.28 hours. The median time to end of progression was 17.48 minutes, and the median time to complete resolution of attack symptoms was 11.95 hours. The safety profile was described as well-tolerated.

Why this matters

Current on-demand HAE treatments are primarily injectable. Firazyr (icatibant) requires subcutaneous injection, Berinert (CSL Behring) requires IV infusion, and Kalbitor (ecallantide) requires subcutaneous injection by a healthcare provider. An oral on-demand option would let patients treat attacks immediately without preparing and administering an injection, which many delay or avoid.

BioCryst (BCRX) markets Orladeyo (berotralstat), an oral prophylaxis drug, but has no oral on-demand product. Pharvaris is also developing an extended-release formulation of deucrictibant for prophylaxis, meaning the same molecule could eventually address both prevention and acute treatment. The PDUFA date of April 23, 2027 is the next regulatory milestone.

Risk factors

Deucrictibant IR faces competition from established injectable therapies with years of real-world safety data. The HAE market is small, with roughly 1 in 50,000 affected. Pharvaris is building commercial infrastructure from scratch and has no marketed products. Detailed adverse event rates from RAPIDe-3 have not yet been published in a peer-reviewed journal, and any emerging safety signal during FDA review could delay approval.

What to watch next

The FDA review runs through April 2027. Pharvaris’s commercial launch readiness will determine how quickly the drug reaches patients if approved. Watch for any FDA information requests or advisory committee scheduling during the review cycle.

PHVS closed at $33.97 on July 25, 2026.

Source: Pharvaris press release | ClinicalTrials.gov RAPIDe-3