Why Reata Pharma (RETA) Shares Are Skyrocketing Today

The FDA approved Reata Pharmaceuticals Inc's RETA Skyclarys (omaveloxolone) for Friedreich's ataxia in adults and adolescents aged 16 and older.
With this approval, the FDA granted a rare pediatric disease priority review voucher.
The company says Skyclarys is the first therapy specifically indicated for Friedreich's ataxia.
Related: Why Reata Pharmaceuticals Shares Are Falling Monday?
Friedreich's ataxia is an ultra-rare, inherited neurodegenerative disorder typically diagnosed during adolescence.
Patients with Friedreich's ataxia experience progressive loss of coordination, muscle weakness, and fatigue, which commonly progresses to motor incapacitation and wheelchair reliance by their teens or early twenties, eventually death.
Friedreich's ataxia affects approximately 5,000 diagnosed patients in the U.S.
The approval of Skyclarys is supported by the efficacy and safety data from the MOXIe Part 2 trial and a post hoc Propensity-Matched Analysis of the open-label MOXIe Extension trial.
Treatment with Skyclarys resulted in statistically significantly lower mFARS scores (less impairment) than placebo at Week 48.
Further, in a post hoc Propensity-Matched Analysis, lower (improved) mFARS scores were observed in patients treated with Skyclarys after three years relative to the matched set of untreated patients from the FA-COMS natural history study.
The company is completing commercial drug product manufacturing and anticipates a commercial drug supply of Skyclarys to be available in the second quarter of 2023.
Price Action: RETA shares are up 166.12% at $82.95 during the premarket session on the last check Wednesday.

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Why Reata Pharma Shares Are Skyrocketing Today