- Reata Pharmaceuticals ( NASDAQ: RETA ) climbed ~14% on above-average volume on Friday as Wall Street awaits the FDA decision on the company's marketing application for Friedreich's ataxia (FA) therapy, omaveloxolone.
- A favorable decision could mark a milestone for the clinical-stage biotech as FA, an inherited neuronal disorder, has no FDA-approved therapies currently.
- More than 1M RETA shares have changed hands, compared to the 65-day average of 581.4K shares, and the stock once jumped over 16% intraday to reach the highest level in more than two years.
- In August, the FDA extended the review period for the company's New Drug Application (NDA) for omaveloxolone in FA by three months, granting February 28, 2023, as the new action date. As the reason for its decision, the agency noted that Reata's ( RETA ) newly submitted data for the NDA was a major amendment that required additional review.
- Seeking Alpha contributor Stephen Ayers issued a Sell rating on Reta ( RETA ) on Friday, citing a potential FDA snub for omaveloxolone and arguing that even if the drug is approved, the company will struggle to market it.
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Reata adds 14% ahead of FDA decision on Friedreich’s ataxia therapy