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:

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