KalVista Pharmaceuticals

The FDA has extended its review of KalVista's sebetralstat for hereditary angioedema by four weeks past the June 17 deadline due to heavy workload and limited resources.

The FDA will not meet the June 17, 2025 PDUFA goal date for KalVista's sebetralstat NDA due to heavy workload and limited resources, with a decision expected within four weeks.

KalVista Pharmaceuticals reported that sebetralstat, an investigational oral plasma kallikrein inhibitor, halted hereditary angioedema attack progression in a median time of 19.8 minutes across both KONFIDENT and KONFIDENT-S trials.

KalVista Pharmaceuticals has completed enrollment in the KONFIDENT-KID trial of sebetralstat, an oral plasma kallikrein inhibitor for children aged 2-11 with hereditary angioedema, a full year ahead of schedule.

Intellia Therapeutics has initiated Phase 3 trials for NTLA-2002, a groundbreaking CRISPR-based gene therapy for hereditary angioedema, with potential U.S. launch targeted for 2027.

KalVista Pharmaceuticals will present new sebetralstat data at multiple upcoming medical conferences, including findings on the oral drug's effectiveness for laryngeal and mucosal hereditary angioedema attacks.

New data from the KONFIDENT-S trial demonstrates sebetralstat's effectiveness in treating HAE attacks, with patients achieving symptom relief within 1.3 hours and treatment initiation within 6-20 minutes.

KalVista's sebetralstat has been granted Orphan Drug Designation by Japan's MHLW, potentially expediting its approval for hereditary angioedema (HAE).

KalVista Pharmaceuticals has filed a New Drug Application with the FDA and a Marketing Authorization Application with the EMA for sebetralstat, an oral therapy for hereditary angioedema (HAE).

The FDA has accepted KalVista's New Drug Application for sebetralstat, an oral treatment for hereditary angioedema (HAE) attacks, with a PDUFA date set for June 17, 2025.