Ardelyx Inc. (ARDX) shares plunged 72.34% in after-hours on Monday, July 19, 2021, and closed the day at $2.13. Earlier in the morning session, ARDX’s stock gained 2.67% to close Monday’s session at $7.70. ARDX shares have risen 13.07% over the last 12 months, and they have moved down 3.87% in the past week. Over the past three months, the stock has lost 12.55%, while over the past six months, it has shed 12.90%.
FDA found deficiencies in NDA for Tenapanor
Ardelyx, Inc received a letter from the U.S. Food and Drug Administration on July 13, 2021, stating that, as part of its ongoing review of the company’s New Drug Application for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis, the FDA has identified deficiencies that preclude discussion of labelling and post-marketing requirements/commitments at this time. The company immediately requested a meeting to discuss the deficiencies and was notified by the FDA today that the request for a meeting was denied. The company broke this news yesterday, July 19, 2021.
Ardelyx 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.
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.
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.
The ARDX stock hit rock bottom on Monday after the company broke the negative outcome about its NDA for Tenapanor. ARDX stock can further go down in the coming days because it was a massive setback for the company and the company needs to address the issues as soon as possible to stop its decline in the stock market.