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Reata (RETA) Announces FDA's Acceptance of Skyclarys PAS
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Reata 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.
Image Source: Zacks Investment Research
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.
Loss per share estimate for Akero Therapeutics has narrowed from $3.22 to $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have declined 0.4% year to date.
AKRO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 7.96%.
Loss per share estimate for ADMA Biologics has narrowed from 19 cents to 9 cents for 2023 in the past 90 days. Shares of ADMA Biologics have risen 1.3% year to date.
ADMA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
Loss per share estimate for Omega Therapeutics has narrowed from $2.51 to $2.05 for 2023 in the past 90 days. Shares of the company have rallied 31.1% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.
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Reata (RETA) Announces FDA's Acceptance of Skyclarys PAS
Reata 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.
Image Source: Zacks Investment Research
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 - Free Report) , ADMA Biologics, Inc. (ADMA - Free Report) and Omega Therapeutics , 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.
Loss per share estimate for Akero Therapeutics has narrowed from $3.22 to $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have declined 0.4% year to date.
AKRO’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 7.96%.
Loss per share estimate for ADMA Biologics has narrowed from 19 cents to 9 cents for 2023 in the past 90 days. Shares of ADMA Biologics have risen 1.3% year to date.
ADMA’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
Loss per share estimate for Omega Therapeutics has narrowed from $2.51 to $2.05 for 2023 in the past 90 days. Shares of the company have rallied 31.1% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.