Analyst Sees This Kidney Illness Firm’s Inventory Might Rise Sixfold, However Lists Two Points

• Piper Sandler raised its value goal on Ardelyx Inc (NASDAQ: ARDX) to $8 from $3 and upgraded to Obese from a Impartial ranking.

• The improve follows a surprisingly constructive advisory committee vote of 9-4 in favor of tenapanor as monotherapy and 10-2 (1 abstention) as combo remedy for controlling serum phosphorus in dialysis-dependent continual kidney illness (CKD).

• Whereas we discovered the vote itself exceptional, it was extra significant that the vote was not cut up alongside “occasion strains,” the analyst wrote.

• To a big shock, the FDA issued a CRL in July 2021 on this indication, regardless of the corporate having run two giant, constructive Part 3 trials with the FDA’s enter on the design and execution of these trials.

• In a uncommon sequence of occasions, ARDX appealed the CRL, bought its day in court docket, and now, yet one more rejection remains to be very a lot a risk. FDA might ask for extra knowledge within the combo remedy setting.

• If granted, the corporate will resubmit the NDA, which might endure a two or six month-review. The precise timing for potential resubmission shouldn’t be clear at this level. For now, Piper fashions a ~YE23 approval and 2024 launch.

• The second problem is money. The corporate presently has <12 months of money at ~$91 million.

• Worth Motion: ARDX shares are up 1.16% at $1.74 in the course of the premarket session on the final test Friday.

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