FDA slaps a hold on KalVista's PhII study of an HAE drug, raising a red flag on preclinical results
Investors on board for KalVista’s roller coaster ride of stock swings are in for some new drama. Two months after the biotech reported positive Phase II results for its lead drug designed to prevent the effects of the rare genetic disorder hereditary angioedema, the FDA has slapped a hold on their Phase II study of their oral drug to prevent HAE.
The biotech hurried to assure investors that no new data would be needed to start the Phase II, but noted:
The FDA letter requests further information and analysis related to certain preclinical studies of KVD824 submitted to support the planned Phase 2 trial. Refinements were also proposed to the intended KVD824 Phase 2 study protocol.
Shares of KalVista dropped 10% by mid-morning.
“We intend to fully comply with the requests and recommendations provided by the FDA,” said Andrew Crockett, the CEO of KalVista. “Although we no longer can confirm that the KVD824 Phase 2 trial will initiate this quarter, we are working to resolve their concerns in a timely fashion. Importantly, this letter relates solely to KVD824, and does not impact our activities or expectations with regard to KVD900, for which we continue to prepare for an End of Phase 2 FDA meeting and commencement of our Phase 3 efficacy trial.”