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Reata (RETA) Omaveloxolone Program Faces Delay on FDA Update
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Reata Pharmaceuticals, Inc. announced that the FDA has proposed additional exploratory analyses for omaveloxolone as a potential treatment of Friedreich’s ataxia (“FA”), following completion of its internal review of a baseline-controlled study. The company completed the pivotal, two-part phase II study — MOXIe — in 2019. The baseline-controlled study was agreed upon by the FDA and the company, during the first meeting to discuss MOXIe data, for additional data to support a new drug application (“NDA”) for omaveloxolone.
The FDA stated that data from the baseline-controlled study do not strengthen the results of Part 2 of the MOXIe study and additional data are required. However, the FDA cautioned that the requested analyses may not be enough to strengthen MOXIe data due to the small number of patients available for analysis. The FDA advised to use patients randomized to placebo during the MOXIe Part 2 study for the additional data. Although requested additional data by the FDA is unlikely to support an NDA filing, it is likely to help shape the future development program for omaveloxolone as potential FA treatment.
The company plans to submit the requested data and meet with the FDA to discuss future path for omaveloxolone. The company may also consider initiating another pivotal study on FA patients. We note that the company was planning to file an NDA in mid-2021, which will likely be delayed following the FDA’s request for additional data. Moreover, the availability of a small number of patients due to the rare nature of the disease and very slow progression rate of FA will pose a challenge to quick completion of the second pivotal study, if initiated.
Shares of Reata declined 8.8% during after-hours trading on Nov 24 on anticipated delay in the omaveloxolone program and its potential approval. The company’s shares have declined 19.5% so far this year while the industry remained flat.
Please note that the MOXIe study was evaluating omaveloxolone as a potential treatment of patients with FA, a rare genetic disease affecting brain and spinal cord. In October 2019, the company announced that the study has met its primary endpoint. However, the FDA was not convinced that these results were enough to support an approval for the candidate without additional evidence and recommended conducting a second pivotal study in a type C meeting requested by Reata.
During its meeting with the FDA, the company convinced the regulatory authority to allow a crossover study instead of pivotal study for additional data. The data showed statistically significant improvement in mFARS (a measure of FA disease progression) compared to placebo after 48 weeks of treatment. The company designed the baseline-controlled study for additional data, which compared changes in mFARS during the pre-treatment period in either part of MOXIe study to changes in mFARS during the treatment period in the open-label extension study (“MOXIe Extension”). The study met its primary endpoint and achieved a statistically significant 3.76-point improvement in mFARS compared to pre-treatment periods.
Apart from omaveloxolone, Reata has another pipeline candidate — bardoxolone methyl — that is being developed for treating chronic kidney disease caused by Alport syndrome and autosomal dominant polycystic kidney disease in late-stage studies. An NDA for Alport syndrome indication is expected to be filed in the first quarter of 2021.
Repligen’s earnings per share estimates have moved up from $1.42 to $1.63 for 2021 in the past 30 days. The company delivered an earnings surprise of 37.36%, on average, in the last four quarters. The stock has risen 93.6% so far this year.
Travere’s loss per share estimates have improved from $2.53 to $2.14 for 2021 in the past 30 days. The company delivered an earnings surprise of 31.73%, on average, in the last four quarters. The stock has surged 64.4% so far this year.
Immunovant’s loss per share estimates have narrowed from $1.67 to $1.45 for 2021 in the past 30 days. The company delivered an earnings surprise of 7.99%, on average, in the last four quarters. The stock has risen 186.3% so far this year.
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Reata (RETA) Omaveloxolone Program Faces Delay on FDA Update
Reata Pharmaceuticals, Inc. announced that the FDA has proposed additional exploratory analyses for omaveloxolone as a potential treatment of Friedreich’s ataxia (“FA”), following completion of its internal review of a baseline-controlled study. The company completed the pivotal, two-part phase II study — MOXIe — in 2019. The baseline-controlled study was agreed upon by the FDA and the company, during the first meeting to discuss MOXIe data, for additional data to support a new drug application (“NDA”) for omaveloxolone.
The FDA stated that data from the baseline-controlled study do not strengthen the results of Part 2 of the MOXIe study and additional data are required. However, the FDA cautioned that the requested analyses may not be enough to strengthen MOXIe data due to the small number of patients available for analysis. The FDA advised to use patients randomized to placebo during the MOXIe Part 2 study for the additional data. Although requested additional data by the FDA is unlikely to support an NDA filing, it is likely to help shape the future development program for omaveloxolone as potential FA treatment.
The company plans to submit the requested data and meet with the FDA to discuss future path for omaveloxolone. The company may also consider initiating another pivotal study on FA patients. We note that the company was planning to file an NDA in mid-2021, which will likely be delayed following the FDA’s request for additional data. Moreover, the availability of a small number of patients due to the rare nature of the disease and very slow progression rate of FA will pose a challenge to quick completion of the second pivotal study, if initiated.
Shares of Reata declined 8.8% during after-hours trading on Nov 24 on anticipated delay in the omaveloxolone program and its potential approval. The company’s shares have declined 19.5% so far this year while the industry remained flat.
Please note that the MOXIe study was evaluating omaveloxolone as a potential treatment of patients with FA, a rare genetic disease affecting brain and spinal cord. In October 2019, the company announced that the study has met its primary endpoint. However, the FDA was not convinced that these results were enough to support an approval for the candidate without additional evidence and recommended conducting a second pivotal study in a type C meeting requested by Reata.
During its meeting with the FDA, the company convinced the regulatory authority to allow a crossover study instead of pivotal study for additional data. The data showed statistically significant improvement in mFARS (a measure of FA disease progression) compared to placebo after 48 weeks of treatment. The company designed the baseline-controlled study for additional data, which compared changes in mFARS during the pre-treatment period in either part of MOXIe study to changes in mFARS during the treatment period in the open-label extension study (“MOXIe Extension”). The study met its primary endpoint and achieved a statistically significant 3.76-point improvement in mFARS compared to pre-treatment periods.
Apart from omaveloxolone, Reata has another pipeline candidate — bardoxolone methyl — that is being developed for treating chronic kidney disease caused by Alport syndrome and autosomal dominant polycystic kidney disease in late-stage studies. An NDA for Alport syndrome indication is expected to be filed in the first quarter of 2021.
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 stocks from the biotech sector include Repligen (RGEN - Free Report) , Travere Therapeutics (TVTX - Free Report) and Immunovant (IMVT - Free Report) , all carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings per share estimates have moved up from $1.42 to $1.63 for 2021 in the past 30 days. The company delivered an earnings surprise of 37.36%, on average, in the last four quarters. The stock has risen 93.6% so far this year.
Travere’s loss per share estimates have improved from $2.53 to $2.14 for 2021 in the past 30 days. The company delivered an earnings surprise of 31.73%, on average, in the last four quarters. The stock has surged 64.4% so far this year.
Immunovant’s loss per share estimates have narrowed from $1.67 to $1.45 for 2021 in the past 30 days. The company delivered an earnings surprise of 7.99%, on average, in the last four quarters. The stock has risen 186.3% so far this year.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 27 billion devices in just 3 years, creating a $1.7 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 6 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2021.
Click here for the 6 trades >>