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

By linda Last updated Nov 18, 2022

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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.

Newest Rankings for ARDX

Date	Agency	Motion	From	To
Mar 2022	Jefferies	Upgrades	Maintain	Purchase
Dec 2021	Citigroup	Maintains		Purchase
Dec 2021	Ladenburg Thalmann	Upgrades	Impartial	Purchase

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View the Newest Analyst Rankings

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