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Tricida Plunges To New Lows On 'Major Setback' For Drug Approval; Headcount Slashed By 61%

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Tricida Plunges To New Lows On 'Major Setback' For Drug Approval; Headcount Slashed By 61%

Shares of Tricida Inc (NASDAQ: TCDA) were hitting new lows Thursday following a regulatory update on veverimer, the only investigational asset in its pipeline.

What Happened: Following an end-of-review conference held as a Type A meeting, the South San Francisco, California-based company said the FDA sought data on the effect of its investigational drug veverimer on renal disease progression for according accelerated approval.

Veverimer is a non-absorbed, orally administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease. Metabolic acidosis is a serious electrolyte disorder resulting from an imbalance in the body's acid-base base, and chronic kidney disease is one of the three major causes. 

The company's NDA for veverimer had a PDUFA action date of Aug. 22. The FDA notified the company regarding deficiencies in the regulatory application on July 15, and subsequently handed down a complete response letter.

Ahead of the Type A meeting, Tricida proposed to conduct an interim analysis of serum bicarbonate data from the VALOR-CKD study in 500 patients treated for 12 months.

If the FDA were to agree to the proposal, the company said it was confident in resubmitting the NDA within months.

From the end-of-review meeting, it appears that the FDA will also require evidence of veverimer's effect on CKD progression from a near-term interim analysis of the VALOR-CKD trial.

The agency is unlikely to rely solely on serum bicarbonate data for determination of efficacy, the company said.

"The introduction of a requirement for data on the effect of veverimer on renal disease progression to support initial accelerated approval clearly represents a major setback in the timeline for the development of veverimer," said Gerrit Klaerne, CEO of Tricida.

Related Link: The Week Ahead In Biotech: Kala FDA Decision, Merck & Pfizer Earnings, Vaccine Updates And IPOs

Tricida Makes Cost Cuts: Amid the veverimer setback, Tricida said it is reorganizing the company to extend its financial runway in order to maximize the options for bringing veverimer to patients.

Consequently, the company said it is reducing its headcount from 152 to 59 people.

This reduction in headcount will reduce annual operating costs by approximately $25 million, the company said. 

Discussions with vendors and contract service providers to potentially provide additional financial flexibility are also ongoing, according to Tricida. 

As of Sept. 30, the company had cash and cash equivalents of about $375 million.

What's Next For Tricida: Tricida said it plans to wait for formal meeting minutes from the FDA related to the end-of-review Type A meeting prior to determining how to proceed with obtaining regulatory approval for veverimer.

The formal minutes are usually received within 30 days from the meeting.

Tricida said it remains committed to bringing veverimer to patients with CKD and metabolic acidosis, for which there is no FDA-approved therapy.

TCDA Price Action: At last check, Tricida shares were slumping 52.82% to $3.90. 

Related Link: The Daily Biotech Pulse: Novartis Acquires Gene Therapy Company, Moderna's Japanese Vaccine Supply Deal

 

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