Achao­gen hits, then miss­es: FDA OKs Zem­dri for cUTIs, but re­jects sec­ond in­di­ca­tion

Fol­low­ing an ad­vi­so­ry com­mit­tee’s sug­ges­tions back in May, the FDA has hand­ed one ap­proval — and one re­jec­tion — to Achao­gen’s lead an­tibi­ot­ic.

Al­though some­what ex­pect­ed, the news ap­pears to be dis­ap­point­ing Achao­gen’s in­vestors. The com­pa­ny’s stock $AKAO is down 11% in pre-mar­ket trad­ing.

Achao­gen’s drug, which now goes by the brand name Zem­dri (pla­zomicin), has been OK’ed to treat com­pli­cat­ed uri­nary tract in­fec­tions. How­ev­er, the agency is­sued a com­plete re­sponse let­ter (CRL) in re­sponse to Achao­gen’s bid to treat blood­stream in­fec­tions, cit­ing lack of ef­fec­tive­ness of the drug in a clin­i­cal study. The com­pa­ny said it plans to meet with the FDA to see if there’s a “fea­si­ble res­o­lu­tion” to ad­dress the CRL.

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