Biopharma company Reata Pharmaceuticals Inc (NASDAQ:RETA) was in the spotlight on Wednesday after a key approval from the US Food and Drug Administration (FDA) sent its stock soaring.
The company announced that the FDA had approved omaveloxolone (brand name SKYCLARYS) for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older.
With this approval, the FDA granted a rare pediatric disease priority review voucher, the company said in a statement.
Shares of Reata were up 170% on Wednesday at $84.46 on the Nasdaq.
Skyclarys treats Friedreich's ataxia. Patients with this neurological disorder experience progressive difficulty walking.
The approval is based on one Phase 3 study called Moxie. Patients treated with Skyclarys showed statistically significant improvements in symptoms after 48 weeks.
Analysts at Citi believe that Skyclarys could bring Reata revenue of around $1.2 billion, noting that the pharma firm’s pipeline should get more focus now that it has shown it can generate a commercial asset.
Citi’s analysts raised their target price on Reata stock to $120 from $53, with a Buy rating.
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