Shares of Reata Pharmaceuticals (RETA Quick QuoteRETA ) increased 20.6% on Oct 14 on investors’ optimism about the FDA’s decision not to hold an advisory committee (AdCom) meeting to review the company’s new drug application (“NDA”) seeking approval for its lead pipeline candidate, omaveloxolone.
The NDA, currently under FDA’s review, is seeking approval for omaveloxolone as a treatment for patients with Friedreich’s ataxia (FA), an inherited disorder that affects some of the body’s nerves. A decision from the FDA on the potential approval of omaveloxolone is expected by Feb 28, 2023.
Before arriving at this decision, the FDA had initially put the AdCom meeting on hold to review Reata’s amendments filed in the NDA. Initially, the NDA filing was supported by data from a two-part pivotal study, MOXIe and MOXIe Extension studies. However, during a mid-cycle meeting with the FDA in the first quarter, the regulatory body raised concerns regarding the strength of the omaveloxolone’s efficacy evidence.
Post the meeting, as confirmatory evidence, Reata submitted additional data, which resulted in the extension of the target action date by an additional three months.
The FDA’s latest decision to waive holding an AdCom meeting also indicates that the additional data submitted by RETA satisfies its earlier concerns.
Shares of Reata Pharmaceuticals have increased 14.6% in the year so far against the industry’s 26.7% decline.
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Presently there are no approved therapies for FA indication. Management estimates that 22,000 individuals worldwide are affected by the disease, out of which nearly 5,000 are living in the United States.
If approved, omaveloxolone will be the first FDA-approved therapy for FA. Management has already started commercial preparations to support the launch of omaveloxolone as a FA therapy in early 2023.
Reata also intends to file a regulatory application for omaveloxolone in FA indication in Europe during the fourth quarter of 2022.
Reata Pharmaceuticals, Inc. Price
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Zacks Rank & Stocks to Consider
Reata currently carries a Zacks Rank #3 (Hold). Some better-ranked stock in the overall healthcare sector includes Aerie Pharmaceuticals (AERI Quick QuoteAERI ) , Catalyst Pharmaceuticals (CPRX Quick QuoteCPRX ) and Morphic (MORF Quick QuoteMORF ) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
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