Ardelyx Stock plummeted after FDA discovery
Ardelyx is a biopharmaceutical enterprise focusing on discovering, developing, and commercializing new first-class drugs for people with kidney and cardiorenal diseases, in order to enhance their treatment.
Ardelyx stock dropped to less than $2.50 in after-hours trading after closing at $7.70 in the regular session for a market capitalization of more than $700 million.
Shares of Ardelyx plunged over 70 percent in after-hours trade Monday as a result of shocking news. Ardelyx made it public: it is doubtful that the biopharmaceutical company’s medicine will be approved for dialysis patients by the Food and Drug Administration.
Deficiencies found in Ardelyx medications
Ardelyx announced that a Food and Drug Administration letter had been received on July 13th claiming that the information enclosed had been judged to be deficient, and was aimed at preventing discussion of the Ardelyx approvals. The letter indicated that the information reviewed does not clearly establish a final decision.
Although the Food and Drug Administration could not disclose particular data on the shortcomings, the company pointed out that the extent of the treatment’s impact, its effects, and its clinical relevance are major issues.
The FDA has detected problems in the company’s New Drug Application (‘NDA’) for the regulation of serum phosphorus in adult patients with chronic kidney disease (‘CKD’) on dialysis.
Ardelyx’s public responses
Ardelyx has requested a meeting in order to examine the flaws, but the FDA rejected it. Ardelyx responded promptly to the public:
‘The FDA noted that a key issue is the size of the treatment effect and its clinical relevance.’
Ardelyx Chief Executive Mike Raab has claimed to the press the following:
‘This is an extremely disheartening and disappointing communication from the FDA, particularly following the weeks of label discussions that occurred in early April, the fact that our NDA submission included three pivotal trials across 1,000 patients, all which met their primary and key secondary endpoints, as well as the additional data analyses we submitted in late April in response to the FDA’s requests. We plan to work with the FDA to learn more about the identified deficiencies and will seek to resolve them as quickly as possible.’
There are concerns regarding Ardelyx’s ability to efficiently resolve the defects found by the Food and Drug Administration and to obtain the regulatory approval for tenapanor. Any reforming declarations made by Ardelyx are subject to change without notice.
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