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Reata Pharma Soars as FDA Requests Preliminary Drug Meeting

Reata Pharmaceuticals soars as the FDA asks for a preliminary drug application meeting for one of its treatments, instead of a more general type of meeting.

Reata Pharmaceuticals  (RETA) - Get Reata Pharmaceuticals, Inc. Class A Report skyrocketed Wednesday after the biopharma said government regulators had asked for a preliminary application meeting to discuss the company's treatment for a neuromuscular disorder in lieu of a more general type of meeting.

Shares of the Plano, Texas company were rising 21.05% to $100.36 at last check.

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Reata said the meeting concerns omaveloxolone, its treatment for Friedreich’s ataxia, a rare degenerative neuromuscular disorder normally diagnosed during adolescence.

The company said that the U.S. Food & Drug Administration's division of neurology products had contacted the company asking for a pre-New Drug Application (NDA) meeting, instead of an upcoming more general Type C meeting.

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The division made the request after preliminary review of briefing materials for the Type C meeting, Reata said, and decided a pre-NDA meeting was the most appropriate format for a discussion of the development program for omaveloxolone.

The company said it plans to withdraw the current request for a Type C meeting and submit a request for a pre-NDA meeting.

“We welcome the opportunity to have a pre-NDA meeting regarding our omaveloxolone development program for the treatment of patients with FA,” Warren Huff, Reata’s president and CEO, said in a statement. “We look forward to working with the FDA on our goal of securing the regulatory review and approval necessary to make omaveloxolone available to patients with [Friedreich's ataxia].”

Last year, Reata warned that a filing for omaveloxolone could be delayed due to a limited number of patients with Friedreich's ataxia. 

In June, Blackstone  (BX) - Get Blackstone Group Inc. Class A Report made a deal with Reata Pharmaceuticals worth $350 million.

The company's shares soared in early 2020 on rumors that it might be acquired by drugmaking giant Amgen  (AMGN) - Get Amgen Inc. Report.