Tricida (NASDAQ:TCDA), a small cap drug manufacturer based in San Francisco, provided a regulatory update on its main product candidate veverimer this week. On July 14th, the company received a notification from the U.S. Food and Drug Administration (FDA) that stated the regulatory body’s identification of deficiencies that preclude a discussion of labeling and postmarketing requirements and commitments.
Veverimer is a non-absorbed, orally administered polymer that is designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). Metabolic acidosis is a condition commonly associated with CKD that is believed to accelerate kidney deterioration. It affects an estimated three million people in the U.S.
Veverimer has been proven to slow CKD progression and lead to improvements in patients’ physical functioning and quality of life.
The unfavorable memorandum did not offer specifics into the deficiencies that were identified by the FDA. However, the FDA did say that the notification did not represent a final decision on the information under review.
Tricida is a $1.3 billion market cap pharmaceutical company focused on the development and commercialization of veverimer, also known as TRC101.
Setback does not mean the treatment cannot be brought to patients
The FDA had been conducting an ongoing review of Tricida’s New Drug Application (NDA) that was recently accepted as part of the agency’s Accelerated Approval Program.
While the news dealt an unexpected and detrimental blow to the company, the positive takeaway is that a final determination of veverimer’s ability to be brought to patients has yet to be made.
Moreover, the drug has already become the first and only FDA-approved therapy for the treatment for metabolic acidosis in patients with CKD.
President and CEO Dr. Gerrit Klaerner commented, “We are surprised and disappointed by this news. We continue to believe in the potential of veverimer to be disease modifying and our goal is to work with (the) FDA to identify and resolve the issues in order to bring veverimer to patients.”
Tricida said it does not anticipate modifying or suspending its ongoing confirmatory postmarketing trial of veverimer referred to as VALOR-CDK. Postmarketing clinical trials are required of pharmaceutical companies after the FDA has approved a product for marketing. The FDA uses the studies to gather additional information about a drug’s efficacy, safety, or optimal use.
The FDA assigned a Prescription Drug User Free Act (PDUFA) target of August 22nd. This is the time at which it can begin to collect fees from Tricida to fund the new drug approval process for veverimer.
The company will now be looking to regain the momentum it had leading up to the FDA notice. Its stock price had climbed from a March 18th low of $18.03 to a peak of $32.99 on May 8th. Following the Tricida’s July 15th FDA announcement the shares dropped 40% to a 52-week low of $15.04.
Tricida is scheduled to report second quarter results on August 13th. Investors will be seeking further details around the metabolic acidosis drug as it relates to the FDA’s postmarketing study.