The FDA Accepts Reata Pharmaceuticals' Filing Of The Prior Approval Supplement To Update The Drug Substance Specification For Skyclarys (Omaveloxolone)
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The FDA has accepted Reata Pharmaceuticals' filing of the Prior Approval Supplement (PAS) to update the drug substance specification for Skyclarys (Omaveloxolone). The PAS is under expedited Priority Review with a target action date of mid-August 2023.
June 16, 2023 | 8:44 am
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Reata Pharmaceuticals' Skyclarys (Omaveloxolone) filing has been accepted by the FDA, with a target action date of mid-August 2023 under expedited Priority Review.
The FDA's acceptance of Reata Pharmaceuticals' filing for Skyclarys (Omaveloxolone) indicates a positive development for the company. The expedited Priority Review suggests that the FDA sees potential in the drug, which could lead to faster approval and commercialization. This news is likely to have a positive short-term impact on Reata's stock price.
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