La Jol­la’s lead drug hits the pri­ma­ry in PhI­II, ig­nit­ing shares as ex­ecs hus­tle to the FDA

Shares of La Jol­la Phar­ma­ceu­ti­cal surged ear­ly Mon­day af­ter the biotech scored a hit on the pri­ma­ry end­point in its Phase III of LJPC-501, test­ed in pa­tients with cat­e­cholamine re­sis­tant hy­poten­sion. But there could be some reser­va­tions about this drug, which was ex­pect­ed to make a mark on the pri­ma­ry but need­ed to achieve key sec­ondary end­points.

70% of the 163 pa­tients test­ed with their drug achieved a pre-spec­i­fied blood pres­sure re­sponse, com­pared to 23% of the 153 pa­tients on a place­bo. That’s a sta­tis­ti­cal­ly sig­nif­i­cant im­pact, set­ting up the biotech’s plans for a reg­u­la­to­ry sub­mis­sion at the FDA.

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