Shares of Tricida, Inc. TCDA plunged 40.31% after it announced the receipt of a notification from the FDA about the identification of deficiencies in its ongoing review of the New Drug Application (NDA) for pipeline candidate, veverimer (TRC101).
Veverimer is a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). Metabolic acidosis is estimated to pose a health risk to approximately three million patients with CKD in the United States.
Due to these deficiencies, the FDA could not discuss labeling and post-marketing requirements/commitments at this time. The FDA stated that the notification does not reflect a final decision on the information under review.
The notification does not specify the deficiencies identified by the FDA.
The NDA for veverimer was accepted for review by the FDA through the Accelerated Approval Program. The FDA had assigned a PDUFA goal date of Aug 22, 2020.
Tricida’s shares have plunged 58.6% in the year so far compared with the industry’s 5.6% decline.
The news was disappointing as it will delay a tentative approval. There are currently no FDA-approved therapies for treating chronic metabolic acidosis.
Results from the company’s phase III, 12-week efficacy trial, TRCA-301, and a follow-on 40-week extension trial, TRCA-301E, formed the primary basis of the NDA submission. The company plans to work with the FDA to identify and seek to resolve the deficiencies. Tricida has no current plans to modify or suspend its ongoing confirmatory post-marketing trial, VALOR-CKD. However, at this time, Tricida is unable to evaluate whether it will be able to address the FDA’s concerns.
Zacks Rank & Key Picks
Tricida currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the healthcare sector include Horizon Therapeutics HZNP, Emergent Biosolutions, Inc EBS and BioMarin Pharmaceuticals BMRN. All three carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Earnings estimates per share for BioMarin for 2020 are up 2 cents in the past 30 days.
Emergent’s earnings per share estimates have increased from $3.18 to $4.03 in the past sixty days for 2020.
Earnings estimates per share for Horizon for 2020 are up 4 cents in the past 30 days.
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