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Reata Pharmaceuticals (NASDAQ:RETA) has more than doubled premarket after the U.S. Food and Drug Administration (FDA) approved SKYCLARYS to treat Friedreich’s ataxia.
Reata shares are currently up more than 172% at $85 per share after closing Tuesday’s session at $31.17.
SKYCLARYS has been approved to treat Friedreich’s ataxia in adults and adolescents aged 16 years and older. The inherited neurodegenerative disorder causes progressive spinal cord, peripheral nerves, and brain damage.
The FDA also granted a rare pediatric disease priority review voucher.
The approval was supported by efficacy and safety data from Reata’s MOXIe Part 2 trial and a post hoc Propensity-Matched Analysis of the open-label MOXIe Extension trial. The company said that treatment with SKYCLARYS “resulted in statistically significant lower mFARS scores (less impairment) relative to placebo at Week 48.”
J Warren Huff, Reata’s chief executive officer, said the approval is an “important milestone for patients” and a “transformative milestone” for the company.
