Arde­lyx craters af­ter FDA stuns an­a­lysts and re­jects their kid­ney dis­ease pitch

Three months af­ter re­veal­ing the FDA had asked for more in­for­ma­tion to sup­port their ap­pli­ca­tion for a chron­ic kid­ney dis­ease drug, Arde­lyx an­nounced that the agency has re­ject­ed it.

The Cal­i­for­nia and Mass­a­chu­setts-based biotech said that the agency was con­cerned with how ef­fec­tive the drug, known as tena­panor, ac­tu­al­ly was, rais­ing ques­tions about the mag­ni­tude of im­prove­ment seen in the com­pa­ny’s Phase III tri­als and whether they would ac­tu­al­ly trans­late in­to a tan­gi­ble ben­e­fit for CKD pa­tients.

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