The drugmaker Tricida, Inc.’s (TCDA) shares experienced a fall of -29.62% in the trading after the ring of the bell on Thursday. The South San Francisco, California-based firm has already seen a decline of -3.92% in its stock’s price in regular session on the day to close at $7.36. The price fall came as the company released weaker results as well as a decline of its drug approval request by authorities.
What actually happened?
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An investigational drug candidate, veverimer (also known as TRC101) is being developed by Tricida, Inc. for patients with chronic kidney disease (CKD). Tricida is currently conducting a renal outcomes trial, VALOR-CKD, to evaluate whether the drug veverimer slows CKD progression. For chronic metabolic acidosis, no FDA-approved treatment is available. Metabolic acidosis is thought to accelerate kidney deterioration in patients with CKD. The condition has been estimated to pose a health risk to approximately three million patients with CKD in the United States.
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Today, the company announced financial results for the fourth quarter and full-year of 2020 and shared an update on its Formal Dispute Resolution Request (FDRR).
Net loss was -$54.8 million or -$1.09 per share for the three months ended December 31, 2020, against a net loss of -$58.2 million or -$1.17 per share posted in the same period of 2019. Analysts were estimating -$0.94 per share of the loss for the reported quarter. For the full year 2020, net loss remained -$264.8 million or -$5.29 per share compared to a net loss of -$176.8 million or -$3.72 for 2019, while analysts estimates were -$5.14 for the same.
As the company announced separately today, it has received a denial letter from the FDA’s Office of New Drugs (OND) in response to its FDRR. Additional deficiencies were also addressed in OND’s decision which also discussed several other concerns which are especially relevant in the context of a new drug authorization supported by a single clinical trial.