Analyst Sees This Kidney Disease Company's Stock Could Rise Sixfold, But Lists Two Issues

  • Piper Sandler raised its price target on Ardelyx Inc ARDX to $8 from $3 and upgraded to Overweight from a Neutral rating.
  • The upgrade follows a surprisingly positive advisory committee vote of 9-4 in favor of tenapanor as monotherapy and 10-2 (1 abstention) as combo therapy for controlling serum phosphorus in dialysis-dependent chronic kidney disease (CKD). 
  • While we found the vote itself remarkable, it was more meaningful that the vote was not split along “party lines,” the analyst wrote.
  • To a significant surprise, the FDA issued a CRL in July 2021 in this indication, despite the company having run two large, positive Phase 3 trials with the FDA’s input on the design and execution of those trials. 
  • In a rare sequence of events, ARDX appealed the CRL, got its day in court, and now, yet another rejection is still very much a possibility. FDA could ask for more data in the combo treatment setting.
  • If granted, the company will resubmit the NDA, which would undergo a two or six month-review. The exact timing for potential resubmission is not clear at this point. For now, Piper models a ~YE23 approval and 2024 launch. 
  • The second issue is cash. The company currently has <12 months of cash at ~$91 million.
  • Price Action: ARDX shares are up 1.16% at $1.74 during the premarket session on the last check Friday.
Market News and Data brought to you by Benzinga APIs
Price Target
Posted In: Analyst ColorBiotechNewsPenny StocksHealth CarePrice TargetSmall CapAnalyst RatingsGeneralBriefs
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!