KalVista Stock Falls After FDA Institutes Clinical Hold On Hereditary Angioedema Trial With KVD824

• Two months after KalVista Pharmaceuticals Inc KALV reported positive Phase 2 results for its lead drug KVD900, an oral therapy meant to stem the effects of swelling attacks caused by the rare genetic disorder hereditary angioedema (HAE), the FDA has issued a hold on their Phase 2 study of KVD824, an oral drug to prevent HAE.


• 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 proposed to the intended KVD824 Phase 2 study protocol.


• Though no new studies were requested, nor was it suggested that new data be generated to initiate the Phase 2 trial.


• “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,” said Andrew Crockett, the CEO.


• Price Action: KALV shares dropped 11.3% at $20.50 in premarket on the last check Tuesday.

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