Ardelyx, Inc. (NASDAQ:ARDX) shares gained more than 9% intra-day today after FDA granted an appeal for a new drug application for Xphozah.
With FDA's OND issuing an Appeal Granted Letter (AGL) for the company's tenapanor, the odds for approval appear to have increased. Wedbush analysts raised their price target on the company’s shares to $3 from $2, while maintaining their Neutral rating. The analysts spoke with the company’s management who remains focused on moving quickly towards an FDA Division meeting and an NDA resubmission (H1/23).
As such, the analysts are re-introducing credit for tenapanor in the hyperphosphatemia setting and assume the earliest potential commercial launch in Q4/23. While the analysts are incrementally positive on the update, they await further clarity on how the cash runway can be extended as an Xphozah launch will require additional investment.