FDA lev­els clin­i­cal hold on Ma­gen­ta's sec­ond lead drug, ask­ing for an ad­di­tion­al bioas­say be­fore it gets to hu­mans

Ear­li­er this sum­mer, Ma­gen­ta Ther­a­peu­tics was forced to say good­bye to its head of R&D at a piv­otal time as the biotech read out da­ta for its lead stem cell con­di­tion­ing hope­ful. Just weeks lat­er, the com­pa­ny’s sec­ond drug is fac­ing a clin­i­cal hold from the FDA as the agency de­mands more in­fo on how the can­di­date works in hu­mans.

Ma­gen­ta will be re­quired to sub­mit an ad­di­tion­al bioas­say to help de­ter­mine the best path for­ward on dose es­ca­la­tion for the biotech’s Phase I/II study of MG­TA-117, an an­ti­body-drug con­ju­gate used to de­plete hematopoi­et­ic stem cells pri­or to a trans­plant of HSC-based gene ther­a­py, the biotech said Wednes­day.

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