Ardelyx Inc. (ARDX) shares jumped 2.92% in after-hours on Thursday, July 29, 2021, and closed the daily trading at $1.76. Earlier in the regular trading session, ARDX’s stock lost 1.16%. The stock volume remained 21.0 million shares, which was higher than the average daily volume of 8.23 million shares within the past 50 days. ARDX shares have fallen 70.87% over the last 12 months, and they have moved down 3.39% in the past week. Over the past three months, the stock has lost 79.72%, while over the past six months, it has declined 75.11%.
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FDA complete response about NDA for Tenapanor
On July 29, 2021, Ardelyx, Inc (ARDX) received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the company’s New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
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The CRL stated that the FDA agrees that “the submitted data provide substantial evidence that tenapanor is effective in reducing serum phosphorus in CKD patients on dialysis, but the magnitude of the treatment effect as small and of unclear clinical significance.
FDA recommends that Ardelyx needs to conduct an additional adequate and well-controlled trial demonstrating a clinically relevant treatment effect on serum phosphorus or an effect on the clinical outcome thought to be caused by hyperphosphatemia in CKD patients on dialysis.
ARDX facing legal battles after FDA setback
After the FDA letter, Ardelyx has to face legal actions, soon after the news on July 19, 2021, Labaton Sucharow, a nationally ranked and award-winning shareholder rights firm, announced that it is investigating potential securities violations and breach of fiduciary duty claims against Ardelyx, Inc.
ARDX Participation in the recent conferences
Ardelyx, Inc recently did two presentations at new tenapanor data at the European Renal Association, European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress 2021, which took place on June 5-8, 2021.
The company also participated in a fireside chat at the Jefferies Virtual Healthcare Conference which was held on Tuesday, June 1, 2021.
ARDX Recent financial results announcement
On May 6, 2021, Ardelyx, Inc announced its financial results for the first quarter ended March 31, 2021.
Q1 2021 financial highlights
- Ardelyx reported revenue of $6.6 million in Q1 2021 compared to $1.2 million in Q1 2020.
- In Q1 2021, research and development expenses were $20.5 million compared to $15.8 million in Q1 2020.
- General and administrative expenses were $17.1 million in Q1 2021 compared to $7.1 million in Q1 2020.
- The company suffered a net loss of 2 million in Q1 2021, as compared to $22.4 million for the quarter ended March 31, 2020.
- Ardelyx had total cash, cash equivalents, and short-term investments of $178.2 million on March 31, 2021, compared to $188.6 million as of December 31, 2021.
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Conclusion
The ARDX stock is declined heavily in the past week due to poor NDA outcomes. Still, there is no clear indication given by the company about its plan for Tenapanor. We hope that ARDX will perform well in the coming days.