Spero’s UTI can­di­date gets the CRL ham­mer as the com­pa­ny falls in­to pen­ny stock sta­tus

Spero Ther­a­peu­tics has been strug­gling in the past few years, deal­ing with FDA holds and staff re­duc­tions amidst a rough biotech mar­ket, and the lat­est news from the Mass­a­chu­setts-based com­pa­ny con­firms what it an­tic­i­pat­ed in May: a CRL.

The com­pa­ny was slapped with the no-go for its NDA, the biotech dis­closed Mon­day. The com­pa­ny was seek­ing ap­proval for tebipen­em HBr oral tablets, in­tend­ed for the treat­ment of adult pa­tients with com­pli­cat­ed uri­nary tract in­fec­tion, or cU­TI, in­clud­ing pyelonephri­tis. The FDA had set a PDU­FA date of June 27.

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