On November 9, 2021, Reata announced that its Phase 3 CARDINAL study of bardoxolone in patients with chronic kidney disease caused by Alport syndrome “met its primary and key secondary endpoints at the end of Year 2,” and that “[b]ased on these positive results and following a recently completed pre-NDA meeting with the [FDA], we plan to proceed with the submission of an NDA … in the first quarter of 2021.”
However, FDA briefing documents released on December 6, 2021 indicate that the FDA in fact “did not agree with the proposed approach” to submit an NDA for bardoxolone under the accelerated approval pathway based primarily on the Year 1 data on eGFR from CARDINAL Phase 3. At the pre-NDA meeting, the FDA had “voic[ed] concerns about the interpretability of the eGFR findings … as well as the amount of missing data in the bardoxolone arm and lack of clarity on how patients with missing data were handled in key analyses ….”
The Company’s stock plunged nearly 40% on December 6, 2021 after the briefing documents were released.
Then, on Wednesday December 8, 2021, after market close, Reata announced that an FDA Advisory Committee voted “no” with respect to the question of whether the data Reata submitted show that bardoxolone slows the progress of chronic kidney disease and whether its benefits outweigh its risks. Reata stock fell 42.8% in pre-market trading the following day, December 9, 2021.