The release of the FDA’s briefing document for a Dec. 8 meeting of its Cardiovascular and Renal Drugs Advisory Committee triggered heavy trading and a 38% drop in value in Reata Pharmaceuticals Inc., of Plano, Texas.
As the world awaits more phase III data due any day from Akebia Therapeutics Inc. with vadadustat, its oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), in chronic kidney disease (CKD), the company is basking in the approval of the product in Japan as Vafseo as a once-daily treatment for CKD anemia.
Wall Street dinged Reata Pharmaceuticals Inc. earlier this week after mixed regulatory news on the nuclear factor erythroid-2 related factor 2 (NRF2) activators omaveloxolone for Friedreich’s ataxia (FA) and bardoxolone for Alport syndrome (AS), but the Plano, Texas-based firm stayed resolute, and its recent deal with Blackstone Life Sciences (BXLS) provides cause for optimism. Increased clarity on paths forward “debunks the bear-case view” of Reata, in the opinion of Jefferies analyst Maury Raycroft, who went as far as to say in a report that the stock “overreaction create[d] a buying opportunity.”
As the company gears up for two NDA filings this year, Reata Pharmaceuticals Inc.’s $350 million deal with funds managed by Blackstone Life Sciences provides cash runway through the end of 2023.