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Piper Sandler raised its worth goal on Ardelyx Inc (NASDAQ: ARDX) to $8 from $3 and upgraded to Chubby from a Impartial score.
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 “get together 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 massive, 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, obtained its day in courtroom, and now, yet one more rejection continues to be very a lot a chance. FDA may ask for extra information within the combo therapy setting.
If granted, the corporate will resubmit the NDA, which might endure a two or six month-review. The precise timing for potential resubmission isn’t clear at this level. For now, Piper fashions a ~YE23 approval and 2024 launch.
The second subject is money. The corporate presently has <12 months of money at ~$91 million.
Value Motion: ARDX shares are up 1.16% at $1.74 throughout the premarket session on the final verify Friday.
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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