Tetraphase lines up a new FDA pitch for an­tibi­ot­ic af­ter it comes through in lat­est PhI­II

A lit­tle more than a year af­ter the FDA sent Tetraphase back to the Phase III draw­ing board af­ter diss­ing their ap­pli­ca­tion for the an­tibi­ot­ic er­ava­cy­cline, the biotech is back tout­ing a pos­i­tive batch of late-stage da­ta. And its shares $TTPH took off on the news, soar­ing more than 30% on the prospect of a turn­around.

These da­ta come from IG­NITE4, the Wa­ter­town, MA-based biotech’s do-over, which was re­quired af­ter the FDA asked for one more Phase III study. Look­ing at a mod­i­fied in­tent-to-treat pop­u­la­tion, Tetraphase says that it gained clear ev­i­dence that its an­tibi­ot­ic was non-in­fe­ri­or to meropen­em in treat­ing com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions. That tri­al en­rolled 500 pa­tients.

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