Ardelyx, Inc (ARDX) PT Raised to $7 at Citi, 'Granting of Appeal Unprecedented'

(Updated - December 29, 2022 3:21 PM EST)

Citi analyst Yigal Nochomovitz raised the price target on Ardelyx, Inc (NASDAQ: ARDX) to $7.00 (from $6.00) while maintaining a Buy rating.

The analyst comments "CDER’s Office of New Drugs (OND) granting of Ardelyx’s formal appeal of the XPHOZAH CRL sets a new and, to the best of our knowledge, unique precedent at FDA. OND has acknowledged that DCN reached an incorrect decision in issuing the CRL and, while perhaps not stated explicitly, has ultimately sided with Ardelyx’s view that the original CRL was capricious and arbitrary. We don’t believe the market is appropriately absorbing the magnitude of this unprecedented regulatory reversal, especially given that OCHEN issued an Appeal Denied Letter on 2/4/22. While there are some details to hammer out (eg, label, review timelines, additional NDA submission requirements), the larger message – which again is apparently being missed – is that the CRL has been formally overturned and that the probability of approval in 2023 is nearly 100%, in our view. We are thus raising our PoS on XPHOZAH to 97.5%, taking our TP to $7."

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