Stem­line wraps pos­i­tive piv­otal tri­al for its con­tro­ver­sial lead can­cer drug, clear­ing a path to the FDA

Back in Feb­ru­ary, Stem­line Ther­a­peu­tics $STML man­aged to put it­self in the mid­dle of a con­tro­ver­sy when it rolled out a $45 mil­lion of­fer­ing, while fail­ing to tip in­vestors off to an­oth­er pa­tient death in its piv­otal study of SL-401 for blas­tic plas­ma­cy­toid den­drit­ic cell neo­plasm due to cap­il­lary leak syn­drome.

Shares dropped, in­vestors cried foul and ac­cu­sa­tions flew on Twit­ter.

But Stem­line’s piv­otal tri­al was nev­er held up by reg­u­la­tors, and to­day the biotech says their drug came through in the study, hit­ting the pri­ma­ry end­point and tout­ing top-line da­ta on Stage 3, where a small group of 13 first-line pa­tients reg­is­tered a com­plete re­sponse rate of 54% and an over­all re­sponse rate of 77%.

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