(RTTNews) - Tricida, Inc. (TCDA) received a Complete Response Letter from the FDA for the New Drug Application for veverimer on August 21, 2020. The FDA is seeking additional data beyond the TRCA-301 and TRCA-301E trials regarding the magnitude and durability of the treatment effect of veverimer. Tricida said, in order to obtain approval for veverimer, the company may or may not have to conduct an additional clinical trial.
Veverimer (TRC101) is a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease.
Tricida plans to request a Type A meeting with the FDA in the coming weeks. Based on the current operating plan, the company believes that it is well positioned financially to fund its operations into early 2022.
Shares of Tricida fell 15% in pre-market trade on Monday.
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