Ar­ray shares surge as PhI­II sets the stage for FDA fil­ing; FDA gives Avadel pri­or­i­ty re­view

→ Shares of Ar­ray Bio­Phar­ma $AR­RY did some bob­bing and weav­ing on Tues­day, but end­ed the day up 23% on pos­i­tive late-stage da­ta from their BEA­CON CRC tri­al for col­orec­tal can­cer. Their triple ther­a­py us­ing a com­bi­na­tion of Braftovi (en­co­rafenib), a BRAF in­hibitor, Mek­tovi (binime­tinib), a MEK in­hibitor, and Er­bitux kicked up an ORR of 26.1% com­pared to just 1.9% for the ce­tux­imab plus irinote­can-con­tain­ing reg­i­mens con­trol group. The me­di­an OS rate was 9.0 months for the triple vs. 5.4 months for the con­trol. A dou­ble us­ing Braftovi plus ce­tux­imab came close with an OS rate of 8.4 months. Ar­ray says it plans to pack­age the da­ta in­to an NDA, with plans to de­liv­er it to the FDA in the sec­ond half of this year. If ap­proved, they say, this will be the first non-chemo ther­a­py tar­get­ing metasta­t­ic col­orec­tal can­cer.

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