News | November 14, 2019

Tricida Announces FDA Acceptance Of New Drug Application For Veverimer

SOUTH SAN FRANCISCO, CALIF.--(BUSINESS WIRE)--

Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for veverimer under the Accelerated Approval Program. In its correspondence, FDA also stated that no filing review issues were identified. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 22, 2020 and indicated that it is currently planning to hold a Cardiovascular and Renal Drugs Advisory Committee meeting to discuss the application.

The NDA submission is supported by data from Tricida’s successful Phase 3 clinical trials that were recently published in back-to-back publications in The Lancet (March 2019 and June 2019).

“We are pleased that our application for veverimer was accepted for review under the Accelerated Approval Program and look forward to engaging with experts at an advisory committee meeting,” said Gerrit Klaerner, Ph.D., Tricida’s chief executive officer and president. “With a potential approval in August 2020, veverimer would be the first and only FDA-approved therapy for the chronic treatment of metabolic acidosis in patients with CKD. Our commercial team is targeting a successful launch with a full quarter of revenue in the fourth quarter of 2020.”

About Metabolic Acidosis

Metabolic acidosis is a chronic condition commonly caused by CKD and is believed to accelerate the progression of kidney deterioration. Metabolic acidosis is estimated to pose a health risk to approximately three million patients with CKD in the United States and currently there are no FDA-approved chronic therapies for treating metabolic acidosis. Metabolic acidosis is a serious condition in which the body has accumulated too much acid and occurs when a patient’s kidneys can no longer excrete sufficient acid or produce enough bicarbonate to balance acid production. The prevalence and severity of metabolic acidosis in people with CKD progressively rises as kidney function declines. As a chronic condition, metabolic acidosis is associated with an increased risk of CKD progression and death. It is also associated with an increased risk of muscle wasting and loss of bone density.

Today’s Conference Call and Webcast

Tricida will host a conference call today at 4:30 pm Eastern Time to discuss its financial results and business progress. Please access the Tricida Conference Call as follows:

Tricida Third Quarter 2019 Conference Call

4:30 pm Eastern Time Today

 

Webcast:

           

IR.Tricida.com

Dial-in:

           

(877) 377-5478

International:

           

(629) 228-0740

Conference ID:

           

4076109

A replay of the webcast will be available on the Investor Relations page of Tricida’s website approximately two hours following the completion of the call and will be available for up to 90 days following the presentation.

About Tricida

Tricida, Inc. is a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with CKD. Tricida is currently conducting its confirmatory postmarketing trial, VALOR-CKD, of veverimer. The Tricida NDA for veverimer is currently under review by the FDA under the Accelerated Approval Program. The FDA has assigned a PDUFA goal date of August 22, 2020.

For more information about Tricida, please visit www.Tricida.com.

Cautionary Note on Forward-Looking Statements

This press release includes forward-looking statements, including for example, statements about the potential timing for approval or commercial launch of veverimer, such as the PDUFA goal date and advisory committee meeting, and the potential availability of the Accelerated Approval Program, as well as the therapeutic potential of, and potential clinical and commercial development plans for, veverimer. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, among others, that we may not be able to achieve upcoming milestones: the cost, timing and results of clinical trials and other studies; that many drug candidates that have completed Phase 3 trials do not become approved drugs on a timely or cost effective basis, or at all; there can be no assurance that the FDA would approve an NDA under the Accelerated Approval Program, or at all, and even if approval for a drug is obtained, there can be no assurance that it will be adopted in the market or accepted as a benefit to patients and healthcare providers; possible safety and efficacy concerns; and that we completely rely on third-party suppliers and manufacturers. These and other factors that may affect our future results of operations are identified and described in more detail in our filings with the Securities and Exchange Commission (SEC), including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. The forward-looking statements contained in this press release reflect Tricida’s current views with respect to future events, and Tricida does not undertake and specifically disclaims any obligation to update any forward-looking statements.

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