Here's Why Tricida Shares Plummeted Today
Shares of Tricida (NASDAQ: TCDA) are down 30% at 1:33 p.m. EST today after the Food and Drug Administration denied the company's appeal of a complete response letter (CRL) that the agency issued for Tricida's marketing application for veverimer as a treatment for chronic kidney disease.
A CRL, like the one Tricida received in August 2020, is essentially a rejection letter from the FDA with instructions on what data the agency would need to see for the drug to eventually get approved. Tricida was trying to get veverimer approved under the accelerated approval pathway, which uses surrogate endpoints, such as biomarkers, to predict clinical outcomes. In Tricida's case, it wanted to use change in serum bicarbonate levels to predict future kidney function in patients with chronic kidney disease.
Rather than address the issues and resubmit the marketing application with more clinical data, which would take awhile, Tricida appealed the FDA's decision, arguing that the change in serum bicarbonate seen in the one clinical trial run by the company was sufficient for accelerated approval.
Source Fool.com
