Tricida Flags Delay In Kidney Disease Trial Data Amid Russia-Ukraine Tension

Tricida Inc TCDA updated on the anticipated date for topline data from the VALOR-CKD trial based on the ongoing events in Ukraine. 

• The VALOR-CKD Phase 3 trial is evaluating the efficacy and safety of TRC101 in delaying chronic kidney disease progression (CKD) in patients with metabolic acidosis.
• The Company said that around 15% of the patients randomized in VALOR-CKD are from Ukraine. 
• Given the uncertainty around the future participation of Ukrainian subjects in the trial and the potential challenges to collecting and monitoring data from Ukrainian sites, topline data from the VALOR-CKD trial is now anticipated early in Q4 2022, versus the previous guidance of Q3 of 2022. 
• Tricida does not expect the utility of the data collected from Ukrainian subjects to be affected. 
• As of March 1, 2022, the VALOR-CKD trial had accrued 197 subjects with positively adjudicated primary endpoint events, defined as renal death, end-stage renal disease (ESRD), or greater than or equal to a 40% decline in estimated glomerular filtration rate (eGFR), with an average treatment duration of approximately 23 months.
• Price Action: TCDA shares closed 4.90% higher at $7.71 on Wednesday.