The U.S. Food and Drug Administration on Tuesday approved Reata Pharmaceuticals Inc's drug for the treatment of a rare genetic disorder that causes progressive damage to the nervous system, sending shares up nearly 160% after the bell.
Reata's case for approval was based on additional data requested by the FDA and a mid-stage study that the drugmaker said showed patients who took the drug experienced an improvement in neurological functions such as speaking, swallowing and standing, compared with a placebo.
The FDA said in 2020 there was not enough evidence to support approval based on the single study, but Reata has since then submitted additional analyses, stopping short of conducting another clinical trial. The FDA has previously approved drugs for neurological conditions based on limited data such as for Biogen Inc'sThose approvals were made under the leadership of Billy Dunn, whofrom the agency on Monday after which Reata's shares tumbled 30% as investors fretted about the possibility of approval under a new division head.
Reporting by Raghav Mahobe, Mariam E Sunny and Pratik Jain in Bengaluru; Editing by Krishna Chandra Eluri and Sherry Jacob-Phillips
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