Andrew Crockett, KalVista CEO

Five months af­ter get­ting slapped with a clin­i­cal hold, KalVista gets the OK to restart oral HAE pro­gram

KalVista’s oral pro­gram for the pre­ven­tion of hered­i­tary an­gioede­ma (HAE) was on­ly on hold for five months — but that was enough time for ri­val Phar­varis to close in with its own on-de­mand and pro­phy­lac­tic treat­ment. Now that KalVista has the FDA’s per­mis­sion to con­tin­ue dos­ing pa­tients, it’s sprint­ing to take the lead in Phase II.

The FDA lift­ed a clin­i­cal hold on KalVista’s KVD824 pro­gram af­ter re­view­ing the com­pa­ny’s re­spons­es to a re­quest for more in­for­ma­tion and analy­sis re­lat­ed to cer­tain pre­clin­i­cal tri­als, the com­pa­ny an­nounced ear­ly Tues­day morn­ing. The news sent the trans-At­lantic biotech’s stock $KALV up 6.25% in pre­mar­ket trad­ing.

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