Briggs Morrison, Syndax Pharmaceuticals CEO (Syndax)

Syn­dax looks to re­bound from sting­ing late-stage fail­ure, un­cork­ing ear­ly da­ta for next can­cer drug up

A year ago, Syn­dax Phar­ma­ceu­ti­cals suf­fered a ma­jor Phase III flop that forced it to for­go an FDA fil­ing for its lead can­cer drug and re­fo­cus on two ear­li­er-stage pro­grams. Now the biotech’s back with Phase I da­ta on one of those can­di­dates, and says it’s ready for a re­bound — but in­vestors aren’t ful­ly con­vinced.

SNDX-5613, an oral menin in­hibitor, achieved a 48% over­all re­sponse rate in 31 evalu­able pa­tients with acute leukemias, Syn­dax said Tues­day. CEO Brig­gs Mor­ri­son, who once held a se­nior R&D post at As­traZeneca, laid out plans for a piv­otal Phase II launch by the end of Q2, which he says could line up an NDA sub­mis­sion in 2023.

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