Ardelyx (NASDAQ:ARDX) Stock Slumps In The Opening Session: A Good Buy Now?
Stocks of Ardelyx (NASDAQ:ARDX) dropped by over 75% in early trading session Tuesday after the firm announced that the FDA may not give permission for the drug for dialysis patients.
The company, focused on discovering and commercialising first-in-class medicines for enhancing patient lives suffering from kidney diseases, disclosed letter from FDA showing shortcomings in information given.
The firm is seeking a meet with FDA for discussing the shortcoming but the request was not approved but said that FDA had confirmed on primary issue being size of treatment effect and its clinical relevance.
Ardelyx Chief Executive Mike Raab said that the communication is disappointing after weeks of discussion in April, especially considering the submission had three important trials in over a 1,000 patients. He added that the trials met primary and key secondary endpoints in addition to the data analysis submitted in late April.
The firm’s shares closed at $7.70 in the regular session and market capitalisation of over $700 million, saw stocks nosedive to less than $2.50 in the after-hours trading period.
Raab also said that the firm will work with FDA to know more about the shortcomings and will also aim to resolve them quickly, in response to the letter dated July 13.
Market Reaction:
As of 11:06, ARDX stock slumped 76% at $1.88 with more than 92.40 million shares, compared to its average volume of 2.23 million shares. The stock has moved within a range of $1.8100 – 2.1500 after opening the trade at $2.23. Over the past 52-week, the stock has been trading within a range of $1.8100 – 9.2300.