Casey Lynch, Cortexyme CEO

Cor­texyme switch­es di­rec­tion, an­nounces lay­offs af­ter FDA slaps hold on dark horse Alzheimer’s can­di­date

Cor­texyme’s ef­forts to de­vel­op an out­side-the-box treat­ment for Alzheimer’s took a sig­nif­i­cant hit Tues­day.

The biotech an­nounced the FDA has put a full clin­i­cal hold on their lead drug for the dis­ease. The agency had al­ready shut­tered one tri­al for the can­di­date af­ter the com­pa­ny re­port­ed el­e­vat­ed signs of liv­er dam­age in vol­un­teers.

As a re­sult, Cor­texyme an­nounced that it’s chang­ing course and will move for­ward with a dif­fer­ent, next-gen­er­a­tion mol­e­cule now in Phase I. The de­ci­sion is a marked de­par­ture from the com­pa­ny’s pos­ture just two months ago when ex­ec­u­tives an­nounced they would al­lay safe­ty con­cerns from reg­u­la­tors and out­side Alzheimer’s ex­perts by sim­ply us­ing a low­er dose of the drug.

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