FDA de­lays PDU­FA date for Lib­tayo lung can­cer com­bo; Swedish biotech hit flunks PhI­II for chemo-en­hanc­ing drug

Dur­ing its earn­ings call yes­ter­day, Re­gen­eron said that the FDA has de­layed its de­ci­sion on Lib­tayo in com­bi­na­tion with chemother­a­py in ad­vanced non-small cell lung can­cer.

“We re­cent­ly were in­formed that an FDA trav­el com­pli­ca­tion re­lat­ing to sched­ul­ing a rou­tine clin­i­cal tri­al site in­spec­tion in East­ern Eu­rope will like­ly de­lay their de­ci­sion un­til af­ter our Sep­tem­ber 19 PDU­FA date,” Re­gen­eron pres­i­dent and CEO Len Schleifer said dur­ing the call.

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