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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.
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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