Reata's (RETA) Skyclarys PAS Gets FDA Nod, Stock Rises 7%
Reata Pharmaceuticals RETA announced that the FDA approved its prior approval supplement (PAS) application to update the drug substance specification for Skyclarys (omaveloxolone). The company further reported that following the PAS approval, Skyclarys is available to patients with Friedreich’s ataxia (FA) in the United States.
Earlier this month, Reata had reported FDA acceptance of the PAS for Skyclarys. It is to be noted that a company files a PAS application with the FDA when certain predefined changes are considered to have a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of a drug product. This is a matter of concern as these factors may relate to the safety or effectiveness of the drug product.
The stock of the company climbed 7% on Wednesday, following the encouraging news. Year to date, shares of Reata have skyrocketed 160.1% against the industry’s 10% decline.
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We would like to remind the investors that in February 2023, the FDA approved Skyclarys for treating FA in adults and adolescents aged 16 years and older. The approval was based on efficacy and safety data from the MOXIe Part 2 study and a post hoc analysis of the open-label MOXIe extension study.
The recommended daily oral dosage for Skyclarys is 150 mg.
FA is an ultra-rare genetic, progressive and neurodegenerative movement disorder that affects approximately 5,000 diagnosed patients in the United States. This disease, which is usually diagnosed during adolescence, causes progressive loss of coordination, muscle weakness and fatigue, eventually resulting in loss of mobility and finally death.
Skyclarys is the first drug to be approved specifically for the treatment of FA and also Reata’s first commercial product. There are no currently approved disease-modifying therapies for FA, which means Reata will enjoy the first-mover advantage for some time. With the product available in the U.S. market, Skyclarys is expected to generate significant revenues for the company.
The FDA has granted Reata a rare pediatric disease priority review voucher along with the approval of Skyclarys.
A regulatory application, seeking approval for Skyclarys as a treatment for FA patients in Europe, is currently under review.
It is important to note that another company that is making a drug for Friedreich’s ataxia is PTC Therapeutics PTCT.
PTC Therapeutics is developing vatiquinone (PTC743) in phase III pivotal studies for children and young adults with FA. PTC Therapeutics’ vatiquinone has been granted Orphan Drug Designation and Fast Track Designation by the FDA. In May 2023, PTCT reported top-line results from its MOVE-FA study on vatiquinone for the treatment of FA.
The study failed to achieve its primary endpoint of statistically significant change in mFARS score at week 72, in the primary analysis population. However, significant benefits on key disease subscales and secondary endpoints were observed upon treatment with vatiquinone. Furthermore, PTCT reported that the mFARS score and several secondary endpoints reached significance in the population of patients that completed the study protocol.
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 Adaptimmune Therapeutics ADAP and Akero Therapeutics AKRO, 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.
In the past 90 days, the Zacks Consensus Estimate for Adaptimmune Therapeutics’ 2023 loss per share has narrowed from 63 cents to 46 cents. During the same period, the estimate for Adaptimmune Therapeutics’ 2024 loss per share has narrowed from 59 cents to 56 cents. Year to date, shares of ADAP have fallen by 37.6%.
ADAP beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 36.89%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $2.96 to $2.80. During the same period, the estimate for Akero Therapeutics’ 2024 loss per share has narrowed from $3.40 to $3.27. Year to date, shares of AKRO have lost 17.1%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
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