Kalvista Pharmaceuticals Inc.
09/15/2021 | Press release | Distributed by Public on 09/15/2021 05:11
Material Event (Form 8-K)
Other Events.
On September 14, 2021, KalVista Pharmaceuticals, Inc. ('KalVista')announced the U.S. Food and Drug Administration ('FDA') lifted the clinical hold on KalVista's Phase 2 clinical trial of KVD824 ('KOMPLETE') for oral prophylactic treatment of hereditary angioedema.
The previously announced clinical hold was removed after FDA review of KalVista's responses to the FDA request for further information and analysis related to certain preclinical studies of KVD824. Refinements were also made to the KVD824 Phase 2 KOMPLETE protocol. KalVista is working closely with study investigators and clinical trial sites to proceed with all study activities as soon as possible.