Reata to seek FDA approval after positive pivotal data in rare disease
Shares of Reata Pharmaceuticals (Nasdaq: RETA) rocketed yesterday, after it said it will seek FDA approval for drug candidate omaveloxolone (omav) for the treatment of Friedreich’s ataxia (FA) following Monday’s announcement of positive data from its registrational clinical trial.
The stock rose 5% by close of trading and then leapt a further 34.4% to $135.43 in after-hours trading.
The study met its primary endpoint, with patients experiencing a significant slowing of disease progression after 48-weeks of treatment. This trial is the first to demonstrate a significant improvement in neurological function in patients with FA and could be the first ever FDA approved drug for these patients.
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