FDA flags deficiencies in Tricida’s Veverimer

Tricida (NASDAQ:TCDA) shares tank ~33% AH in reaction to the FDA notification regarding “deficiencies” regarding labeling and postmarketing requirements for veverimer for metabolic acidosis in chronic kidney disease patients. Though the notice doesn’t specify the deficiencies identified by the FDA.

Tricida says the notification doesn’t reflect a final decision, and it will work with the FDA to identify and seek to resolve deficiencies.

The company has no plans to modify/suspend its ongoing confirmatory postmarketing trial, VALOR-CKD.

Marketing application was filed in September last year.

https://seekingalpha.com/news/3591669-fda-flags-deficiencies-in-tricidas-veverimer