Pharvaris receives regulatory acceptance for drug application

• Pharvaris (NASDAQ:PHVS) secured FDA acceptance for its New Drug Application for deucrictibant 20 mg capsules.
• The regulatory acceptance sets a definitive federal action target date for the clinical asset in April 2027.
• The company plans to advance the capsule as an on-demand therapeutic choice for hereditary angioedema attacks.

Pharvaris (NASDAQ:PHVS) announced the FDA accepted its regulatory application for its 20 mg hereditary angioedema on-demand treatment capsule.

The drug candidate previously received an official orphan drug designation from federal regulators back in 2022.

The submission incorporates comprehensive clinical data compiled from the treatment of over 1,300 hereditary angioedema attacks.

The company stated that federal regulators set a final decision action deadline for the program on April 23, 2027.

Following the announcement, Pharvaris' share price was unchanged at $33.86.

In the pivotal Phase 3 RAPIDe-3 trial, the experimental therapeutic capsule successfully met all 11 secondary efficacy endpoints.

The clinical research demonstrated rapid symptom relief and a well-tolerated safety profile across the entire tested patient group.