The U.S. Food and Drug Administration (FDA) extended the review period of Reata Pharmaceuticals' ( NASDAQ: RETA ) application by three months drug which seeking the approval of omaveloxolone to treat Friedreich's Ataxia.
The FDA is now expected to make a decision on the new drug application (NDA) by Feb. 28, 2023.
Reata stock slumped ~33% a day ago (Aug. 8) after the company said in its Q2 results that during a meeting with the FDA, the agency raised concerns over the strength of the efficacy data currently under review.
Reata said in a Aug. 9 release that it recently submitted updated data, which were provided as confirmatory evidence of the results of the MOXIe Part 2 study in response to concerns raised by the FDA during the communication meeting.
The FDA determined that these submissions were a major amendment to the NDA and thus extended the time period for full review of the new data and analyses, according to the company.
Reata added that the FDA put the planned advisory committee meeting on hold pending review of the new NDA amendments.
Friedreich's ataxia a genetic, progressive, neurodegenerative movement disorder, which includes symptoms such as difficulty in walking, fatigue, changes in sensation, and slowed speech, among others.
RETA -1.04% to $23.81 premarket Aug. 9
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Reata stock slips as FDA extends review period for rare disorder drug omaveloxolone