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Home Bio/Med/Pharma

FDA Grants Approval of Reata Pharmaceuticals’ (NASDAQ: RETA) SKYCLARYS Drug, Making the First and Only Drug for Friedreich’s Ataxia

by admin

March 1, 2023

in Bio/Med/Pharma

Reata Pharmaceuticals NASDAQ RETA FDA Approval SKYCLARYS Friedreich's Ataxia Spotlight Growth

Reata Pharmaceuticals, Inc. (NASDAQ: RETA) is engaged as a biopharmaceutical company, which is focused on the research, development and commercialization of therapies for life-threatening diseases. Shares of the biopharma company are skyrocketing 182% through early trading on Wednesday, March 1, 2023. Over the past three months, Reata Pharmaceuticals has seen average daily volume of 1.01 million shares. However, volume of 6.25 million shares or dollar volume of around $552.44 million, has already exchanged hands through early trading.

Shares of Reata Pharmaceuticals are surging after the company announced that the U.S. Food and Drug Administration (FDA) has approved SKYCLARYS for the treatment of Friedreich’s ataxia in patients aged 16 years and older. The FDA approval came as a result of a granted rare pediatric disease priority review voucher.

Friedreich’s ataxia is a very rare, progressive neuromuscular disease that affects 5,000 diagnosed patients in the United States. The disease is inherited and typically diagnosed during adolescence. The disease causes progressive loss of coordination, muscle weakness, fatigue and more. The disease has been known to cause reliance on a wheelchair by the patient’s late teens or early twenties, eventually resulting in death.

The FDA’s approval came as SKYCLARYS was found to have strong efficacy and safety from its MOXle Part 2 trial and a post hoc Propensity-Matched Analysis of the open-label MOXle Extension trial.

“The approval of SKYCLARYS, the first therapy specifically indicated for the treatment of Friedreich’s ataxia, is an important milestone for patients affected by this disease as well as their families and caregivers,” said Warren Huff, Reata’s Chief Executive Officer. “We are grateful to Friedreich’s ataxia patients, investigators, U.S. regulators, and our scientists and employees who made this approval possible. As a company, this is a transformative milestone that highlights our commitment to developing and commercializing novel therapies for patients with severe diseases with few or no approved therapies. We look forward to delivering SKYCLARYS to eligible patients as quickly as possible.”

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