(RTTNews) - Tricida, Inc. (TCDA) announced that it received a notification on July 14, 2020, as part of its ongoing review of Veverimer New Drug Application, stating that the FDA has identified deficiencies that preclude discussion of labeling and postmarketing requirements/commitments at this time. Following the news, the company's stock fell 32% to $17.85 in the after-hours trading.
Veverimer or TRC101 is a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease.
The notification does not specify the deficiencies identified by the FDA. The company said it plans to work with the FDA to identify and seek to resolve the deficiencies. However, the company said at this time it is unable to evaluate whether it will be able to address the FDA's concerns.
The company has no current plans to modify or suspend its ongoing confirmatory postmarketing trial, VALOR-CKD.
Meanwhile, the FDA has stated that the notification does not reflect a final decision on the information under review.
"We are surprised and disappointed by this news," said Gerrit Klaerner, Tricida's Chief Executive Officer and President.
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