The FDA's Cardiovascular and Renal Drugs Advisory Committee voted that the agency should not approve Reata Pharmaceuticals Inc's (NASDAQ:RETA) bardoxolone methyl capsules to slow the progression of chronic kidney disease in those with the rare Alport syndrome.

• Adcomm members largely agreed with the agency, citing safety concerns. Members of the committee also sought clarifications on why Reata used eGFR as the primary measure for its Phase 3, noting other measures might have been more informative.
• Related Link: FDA Raises Concerns On Reata's Kidney Disease Drug Data; Shares Plunge.
• The use of eGFR, which is an estimate of the kidney's filtration rate, was meant to assess disease progression.
• Reata argued that Phase 3 showed patients treated with bardoxolone experienced a statistically significant improvement in kidney function as measured by eGFR at Week 100 and Week 104, compared to patients treated with placebo.
• Nearly every Adcomm member seemed to disagree with that conclusion.
• Reata will continue to work closely with the agency to provide additional information and data until the upcoming Prescription Drug User-Fee Act date of February 25, 2022.
• Price Action: RETA shares are down 42.9% at $31.06 during the premarket session on the last check Thursday.