Reata Pharmaceuticals won the Food and Drug Administration's blessing to go ahead with production of its Friedreich's ataxia drug. RETA stock advanced in response.
Specifically, the FDA signed off on a supplemental application that pertains to the drug's manufacturing process. Reata says the drug, dubbed Skyclarys, is now available to patients age 16 and older. Friedreich's ataxia is a genetic disorder that affects the nerves and can cause muscle weakness and fatigue.
Reata's Skyclarys is the first treatment approved for Friedreich's ataxia. It's a once-daily pill. The company also is working to win approval in Europe.
On today's stock market, RETA stock jumped 7% and closed at 98.83.
RETA Stock: Early Skyclarys Decision
After gaining initial FDA approval in February, RETA stock nearly tripled. But the company said it would delay launching Skyclarys after finding an impurity in the manufacturing process. The FDA said it would review Reata's request to increase the limit on how much of that impurity can show up in the process.
The decision, which came late Tuesday, is much earlier than expectations for mid-August.
The move puts RETA stock closer to a buy point at 105.55 out of a cup-with-handle base that began forming in May, according to MarketSmith.com.
It's also important to note that Reata shares have a best-possible IBD Digital Relative Strength Rating of 99. This means RETA stock ranks among the top 1% of all stocks in terms of 12-month performance. Shares have soared more than 143% this year as of Tuesday's close.
But RETA stock has a lower Composite Rating — a measure of fundamental and technical performance — at 55.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
