Reata (RETA) Announces FDA's Acceptance of Skyclarys PAS
Reata RETA announced that the FDA has accepted the Prior Approval Supplement (PAS) to update the drug substance specification for Skyclarys (omaveloxolone).
In February 2023, the company received FDA approval for Skyclarys in adult and adolescents aged 16 years and older for the treatment of an ultra-rare disease called Friedreich’s ataxia (FA).
The acceptance of the PAS signifies that the agency has confirmed that the submission is complete enough to undergo substantive review. Reata has been working closely with the FDA to ensure the completeness and accuracy of the submission. The recommended daily oral dosage for Skyclarys is 150 mg.
Shares of RETA have risen 145.8% year to date against the industry’s 6.1% decline.
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FA is an ultra-rare genetic, progressive, neurodegenerative movement disorder that affects approximately 5,000 diagnosed patients in the United States.
Skyclarys is the first drug to be approved specifically for the treatment of FA. It is also Reata’s first commercial product.
With no existing approved therapies for the condition, the company stands to benefit from a significant first-mover advantage in the market for an extended period. As a result, Skyclarys is expected to yield substantial revenues for the company.
RETA had previously communicated that the PAS for Skyclarys is being assessed under expedited priority review. This designation is reserved for therapies that address serious conditions and show the potential to provide significant improvements in safety or effectiveness compared with existing treatments.
The target action date for the PAS’ review is set for mid-August 2023. Management expects Skyclarys to be launched by mid-August 2023, if the FDA finds no issues with the review.
A regulatory application seeking approval for Skyclarys as a treatment for FA patients in Europe is currently under review.
Reata Pharmaceuticals, Inc. Price and Consensus
Reata Pharmaceuticals, Inc. price-consensus-chart | Reata Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Reata currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Akero Therapeutics AKRO, ADMA Biologics, Inc. ADMA and Omega Therapeutics OMGA, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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