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Reata Pharmaceuticals, Inc. announced that the FDA has accepted its new drug application (“NDA”) for its lead pipeline candidate, omaveloxolone. The NDA is seeking approval for the candidate as a treatment for patients with Friedreich’s ataxia, an inherited disorder that affects some of the body's nerves.
The FDA has granted priority review designation to the omaveloxolone NDA. A priority review designation shortens the review period of an NDA from 12 months to 8 months. The candidate also enjoys Fast Track designation and Rare Pediatric Disease designation.
A decision from the FDA on the potential approval of omaveloxolone is expected by Nov 30, 2022.
Following a potential approval, omaveloxolone will become the first FDA-approved therapy for the rare, genetic neuromuscular disorder, Friedreich’s ataxia. Reata expects to launch the candidate in early 2023.
Shares of Reata gained 3.4% on May 26, following the FDA acceptance of omaveloxolone NDA. In fact, Reata’s shares have gained 5.4% so far this year against the industry’s decrease of 24.3%.
Image Source: Zacks Investment Research
The NDA for omaveloxolone was supported by data from a two-part pivotal study, MOXIe, as well as MOXIe Extension studies.
Reata successfully completed the pivotal MOXIe study on its omaveloxolone as a potential treatment for FA in 2019. The data showed a statistically significant improvement in mFARS (a measure of FA disease progression) compared to placebo after 48 weeks of treatment. The company also successfully completed a baseline-controlled study (crossover study) and exploratory analyses for additional data requested by the FDA previously.
The company is also developing another pipeline candidate, bardoxolone, as a potential treatment for chronic kidney disease (“CKD”) caused by the Alport syndrome. The CRL indicated that the regulatory body could not approve the NDA in its present form. The submission of omaveloxolone NDA boosts the prospects of a commercialized product for Reata by next year.
Please note that the CRL for bardoxolone NDA was based on the negative outcome of an FDA advisory committee. The committee stated that clinical data provided with the NDA does not support the effectiveness of the candidate in slowing the progression of CKD.
Reata continues to work with the FDA to decide the next step for bardoxolone. However, this will significantly delay any potential approval to the candidate for treating CKD.
Meanwhile, Reata is also developing bardoxolone for treating autosomal dominant polycystic kidney disease (“ADPKD”) in a late-stage study. The company recently filed a protocol amendment and requested a Type A meeting with the FDA to discuss the ADPKD development program.
Reata currently carries a Zacks Rank #3 (Hold). Some better-ranked biotech/drug stocks are Alkermes (ALKS - Free Report) , ProPhase Labs (PRPH - Free Report) and Sesen Bio . While ProPhase and Sesen Bio sport a Zacks Rank #1 (Strong Buy), Alkermes carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 10 cents to 3 cents in the past 30 days. Shares of ALKS have risen 24% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.48%.
Earnings estimates for ProPhase’s 2022 bottom line have improved from earnings of 27 cents per share to 55 cents per share over the past 30 days. PRPH stock is up 23.8% this year so far.
ProPhase exceeded earnings expectations in two of the last four quarters, while missing the same twice. The company has a negative four-quarter earnings surprise of 130.56%, on average.
The Zacks Consensus Estimate for Sesen Bio’s 2022 loss has declined from 33 cents to 32 cents per share in the past 30 days. Shares of SESN have declined 38.1% in the year-to-date period.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.94%.
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Reata (RETA) Friedreich's Ataxia NDA Gets Priority Review
Reata Pharmaceuticals, Inc. announced that the FDA has accepted its new drug application (“NDA”) for its lead pipeline candidate, omaveloxolone. The NDA is seeking approval for the candidate as a treatment for patients with Friedreich’s ataxia, an inherited disorder that affects some of the body's nerves.
The FDA has granted priority review designation to the omaveloxolone NDA. A priority review designation shortens the review period of an NDA from 12 months to 8 months. The candidate also enjoys Fast Track designation and Rare Pediatric Disease designation.
A decision from the FDA on the potential approval of omaveloxolone is expected by Nov 30, 2022.
Following a potential approval, omaveloxolone will become the first FDA-approved therapy for the rare, genetic neuromuscular disorder, Friedreich’s ataxia. Reata expects to launch the candidate in early 2023.
Shares of Reata gained 3.4% on May 26, following the FDA acceptance of omaveloxolone NDA. In fact, Reata’s shares have gained 5.4% so far this year against the industry’s decrease of 24.3%.
Image Source: Zacks Investment Research
The NDA for omaveloxolone was supported by data from a two-part pivotal study, MOXIe, as well as MOXIe Extension studies.
Reata successfully completed the pivotal MOXIe study on its omaveloxolone as a potential treatment for FA in 2019. The data showed a statistically significant improvement in mFARS (a measure of FA disease progression) compared to placebo after 48 weeks of treatment. The company also successfully completed a baseline-controlled study (crossover study) and exploratory analyses for additional data requested by the FDA previously.
The company is also developing another pipeline candidate, bardoxolone, as a potential treatment for chronic kidney disease (“CKD”) caused by the Alport syndrome. The CRL indicated that the regulatory body could not approve the NDA in its present form. The submission of omaveloxolone NDA boosts the prospects of a commercialized product for Reata by next year.
Please note that the CRL for bardoxolone NDA was based on the negative outcome of an FDA advisory committee. The committee stated that clinical data provided with the NDA does not support the effectiveness of the candidate in slowing the progression of CKD.
Reata continues to work with the FDA to decide the next step for bardoxolone. However, this will significantly delay any potential approval to the candidate for treating CKD.
Meanwhile, Reata is also developing bardoxolone for treating autosomal dominant polycystic kidney disease (“ADPKD”) in a late-stage study. The company recently filed a protocol amendment and requested a Type A meeting with the FDA to discuss the ADPKD development program.
Reata Pharmaceuticals, Inc. Price
Reata Pharmaceuticals, Inc. price | Reata Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Reata currently carries a Zacks Rank #3 (Hold). Some better-ranked biotech/drug stocks are Alkermes (ALKS - Free Report) , ProPhase Labs (PRPH - Free Report) and Sesen Bio . While ProPhase and Sesen Bio sport a Zacks Rank #1 (Strong Buy), Alkermes carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 10 cents to 3 cents in the past 30 days. Shares of ALKS have risen 24% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 350.48%.
Earnings estimates for ProPhase’s 2022 bottom line have improved from earnings of 27 cents per share to 55 cents per share over the past 30 days. PRPH stock is up 23.8% this year so far.
ProPhase exceeded earnings expectations in two of the last four quarters, while missing the same twice. The company has a negative four-quarter earnings surprise of 130.56%, on average.
The Zacks Consensus Estimate for Sesen Bio’s 2022 loss has declined from 33 cents to 32 cents per share in the past 30 days. Shares of SESN have declined 38.1% in the year-to-date period.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.94%.