- The stock price of Reata Pharmaceuticals Inc (NASDAQ: RETA) increased by over 14% pre-market. This is why it happened.
The stock price of Reata Pharmaceuticals Inc (NASDAQ: RETA) increased by over 14% pre-market. Investors are responding positively to the company announcing that it received a communication from the Division of Neurology Products 1 of the U.S. Food and Drug Administration stating that, after a preliminary review of briefing materials for an upcoming Type C meeting, a pre-NDA meeting is the most appropriate format for a discussion of the development program for omaveloxolone in Friedreich’s ataxia.
The Division suggested that Reata Pharmaceuticals withdraws the current meeting request for a Type C meeting and instead request a pre-NDA meeting, which the Division will grant upon receipt. And the Division asked Reata Pharmaceuticals to focus the new briefing package on questions, issues, and needs applicable to a pre-NDA meeting. As requested by the FDA, Reata Pharmaceuticals plans to withdraw the current request for a Type C meeting and submit a request for a pre-NDA meeting as soon as practicable.
“We welcome the opportunity to have a pre-NDA meeting regarding our omaveloxolone development program for the treatment of patients with FA,” said Reata’s President and Chief Executive Officer Warren Huff. “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 FA.”
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