BioCentury
ARTICLE | Product Development

Friedreich’s ataxia program hits FDA snag, denting Reata’s shares

November 25, 2020 9:16 PM UTC

FDA’s conclusion about data Reata added to a potentially registrational package for its Friedreich’s ataxia program sliced about $420 million from the company’s market cap, and could complicate the therapy’s path to U.S. approval.

The agency said results from Reata’s Baseline-Controlled Study of omaveloxolone “do not strengthen” prior data from its pivotal Phase II MOXIe trial to treat Friedreich’s ataxia. The newer analysis was designed to evaluate patients as their own controls, comparing data from an extension study in which they received the drug from their results while receiving placebo during a randomized part of MOXIe...

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Reata Pharmaceuticals Inc.