Rigel’s 2nd PhI­II for fos­ta­ma­tinib scut­tled by a sin­gle place­bo re­sponse, shares crater

Rigel Phar­ma­ceu­ti­cals con­tin­ues to be plagued by a low re­sponse rate in its big Phase III pro­gram for fos­ta­ma­tinib. But un­like its first late-stage da­ta drop, which scored a hit on the pri­ma­ry end­point, the biotech now has to ex­plain why its sec­ond con­fir­ma­to­ry study failed.

It’s not an en­vi­able task. At the end of Au­gust the South San Fran­cis­co-based biotech’s share price $RIGL went on a roller coast­er ride with a pos­i­tive but unim­pres­sive 18% re­sponse rate for im­mune throm­bo­cy­tope­nia pa­tients who achieved a sta­ble platelet re­sponse. That was ex­act­ly the same rate seen in the sec­ond Phase III, on­ly this time one pa­tient on a place­bo al­so achieved a sta­ble platelet re­sponse, and that scut­tled any shot at hit­ting the pri­ma­ry end­point. For an­a­lysts who had been look­ing for a re­sponse rate at least in the low 20s with clear signs of ef­fi­ca­cy, this stum­ble will not play well.

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