Clinical hold of deucrictibant for on-demand treatment lifted by FDA

The U.S. Food and Drug Administration (FDA) has lifted its hold on clinical trials of deucrictibant for the on-demand treatment of hereditary angioedema (HAE). The therapy’s developer Pharvaris now expects to resume RAPIDe-2 (NCT05396105), a long-term extension study evaluating PHVS416, an immediate-release capsule formulation of deucrictibant,…

FDA Places Hold on US Clinical Trials of PHA121 Therapy for HAE

The U.S. Food and Drug Administration (FDA) has placed a clinical hold on trials testing the investigational therapy PHA121 (PHA-022121) in people with hereditary angioedema (HAE). The hold is “based on [a] review of nonclinical data,” Pharvaris, the therapy’s developer, said in a press release. According to…

FDA Lifts Hold, Allows Phase 2 Trial of KVD824 for HAE to Open

The U.S. Food and Drug Administration (FDA) has lifted the hold it had placed on KalVista Pharmaceuticals’ Phase 2 KOMPLETE trial of KVD824 as a treatment to prevent swelling attacks in people with hereditary angioedema (HAE). KalVista said it is working closely with study investigators and clinical sites so…

FDA Puts Hold on KalVista’s Phase 2 Trial of KVD824 for HAE Attacks

The U.S. Food and Drug Administration (FDA) has placed a hold on KalVista Pharmaceuticals’ proposed Phase 2 trial of KVD824 — which the developer had expected to launch by the end of June.  The trial is intended to test…