Ku­ra tees up its lead drug with a 'break­through' at the FDA; NCI teams up with Cy­brexa on pep­tide drug con­ju­gate

Ku­ra On­col­o­gy CEO Troy Wil­son laid out some good news for in­vestors this morn­ing as he set the stage for their Q4 re­view.

The biotech has won a break­through ther­a­py des­ig­na­tion for its lead drug tip­i­farnib for re­cur­rent or metasta­t­ic HRAS mu­tant head and neck squa­mous cell car­ci­no­ma with vari­ant al­lele fre­quen­cy ≥ 20% af­ter dis­ease pro­gres­sion on plat­inum-based chemother­a­py.

The drug is cur­rent­ly in a piv­otal tri­al, giv­ing Ku­ra the key to the front door at the FDA as ex­ecs start to set the stage for a pos­si­ble ap­proval. And they’ll be look­ing for a pri­or­i­ty re­view and oth­er pos­si­ble short­cuts in a dri­ve to cut the time to a mar­ket­ing de­ci­sion.

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