FDA Raises Concerns On Reata's Kidney Disease Drug Data; Shares Plunge

Reata Pharmaceuticals Inc RETA shares are trading lower during the market trading session after the FDA released briefing documents ahead of the Advisory Committee meeting scheduled on December 08 for marketing application for the kidney disease drug bardoxolone methyl.

• The application for bardoxolone seeks approval as a treatment for patients with chronic kidney disease (CKD) caused by Alport syndrome (AS). This disease can cause damages to tiny blood vessels in the kidneys.
• In its staff documents, the regulator has cited its concerns over the clinical data submitted by the Company regarding the estimated glomerular filtration rate (eGFR), a key measure on kidney function and the primary endpoint of the trial that supported the NDA submission.
• In addition to the concerns with CARDINAL Phase 3, there are no data in this application from an animal model of Alport syndrome or other adequate and well-controlled clinical trials in AS or CKD that show that bardoxolone slows the loss of kidney function, the FDA said.
• Despite the Company's explanation, the "loss of statistical significance based on a change in a single factor in the analytic model raises concerns regarding the robustness of the study's findings," the federal agency wrote in its review.
• Related Link: Reata's Stock Plunges After FDA Identifies Review Issues With Bardoxolone Methyl US Application.
• Price Action: RETA shares are down 37.9% at $48.89 during the market session on the last check Monday.