CRL ap­peal lands Arde­lyx an FDA ad­comm meet­ing for em­bat­tled CKD drug

Arde­lyx’s roller-coast­er ride at the FDA for its po­ten­tial chron­ic kid­ney dis­ease drug seemed like it al­most stopped for good, but now it’s on the up­swing again.

Late last sum­mer, Arde­lyx’s key po­ten­tial CKD drug ran in­to a sur­pris­ing CRL, saw its stock price plum­met 71% with­in hours, forc­ing the com­pa­ny to lay off 65% of its work­force, or over 100 em­ploy­ees, two months af­ter let­ting go an­oth­er 80 em­ploy­ees.

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