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The Latest Breaking News from Office of New Drugs

FDA Plans To Convene AdComm For Ardelyx's Tenapanor For CKD Patients On Dialysis

The FDA's Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), has provided an interim response to Ardelyx Inc's (NASDAQ:ARDX) second level of appeal of the Complete Response Letter (CRL) for Xphozah. Ardelyx is seeking approval for Xphozah to control serum phosphorus in adult patients with chronic kidney disease (CKD) on…

Benzinga · Apr 25, 2022

Jefferies Raises Price Target On This Small-Cap 'Stand Out' Biotech Stock

Jefferies Raises Price Target On This Small-Cap 'Stand Out' Biotech Stock

Ardelyx Inc (NASDAQ:ARDX) shares are trading higher after Jefferies upgraded shares to Buy from Hold and raised the price target on the stock to $5 from $1. Analyst Chris Howerton thinks Ardelyx "stands out" given that the Company has an approved IBS-C product, Isbrela, that will launch in April and whose commercial…

Benzinga · Mar 2, 2022

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