The analyst sees the kidney disease company’s stock possibly growing six times, but lists two problems

news7f11/19/2022

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Flute machine increase its price target on Ardelyx Co (NASDAQ: ARDX) to $8 from $3 and upgraded to Overweight from Neutral rating.
The upgrade after a surprisingly active advisory committee votes 9-4 favor tenapanor as monotherapy and 10-2 (1 abstention) as combination therapy for control of serum phosphorus in dialysis-dependent chronic kidney disease (CKD).
While we ourselves found the vote remarkable, what was more significant was that the vote was not split along “partisan lines,” the analyst wrote.
To a significant surprise, the FDA issued a CRL in July 2021 for this indication, although the company conducted two large, positive Phase 3 trials with FDA comments on the design. and perform those tests.
In a rare sequence of events, ARDX appealed to the CRL, went to court, and now, there is still the possibility of another denial. FDA may require additional data in combination treatment settings.
If granted, the company will resubmit the NDA, which will be reviewed in two or six months. The exact time for potential resends is unclear at this time. Currently, Piper has modelled ~YE23 approved and launched in 2024.
The second problem is cash. The company now has <12 months of cash at ~$91 million.
Price action: ARDX stock was up 1.16% at $1.74 in the premarket on Friday’s final test.