We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Reata (RETA) Stock Doubles This Year on Skyclarys FDA Nod
Read MoreHide Full Article
Reata Pharmaceuticals’ shares have more than doubled in 2023. The main reason for the surge is the approval of its Skyclarys or omaveloxolone, across a broad patient population of an ultra-rare disease named Friedreich’s ataxia on Feb 28.
Reata's shares have surged 118.4% year over year compared to the industry's 9.2% decline.
Image Source: Zacks Investment Research
The FDA approved Reata's Skyclarys (omaveloxolone) for Friedreich's ataxia in adults and adolescents aged 16 and older.
Friedreich's ataxia is an ultra-rare genetic, progressive and neurodegenerative movement disorder that affects approximately 5,000 people in the United States. This disease, usually diagnosed during adolescence, causes progressive loss of coordination, muscle weakness and fatigue, eventually resulting in loss of mobility and death.
There are no currently approved disease-modifying therapies for Friedreich's ataxia, which means Reata will enjoy the first-mover advantage for some time. Skyclarys is the first therapy explicitly indicated for treating Friedreich's ataxia. It is also Reata's first commercial product. The company expects the drug to be available commercially in the second quarter of 2023.
Although there are no currently approved therapies for Friedreich's ataxia, several companies are developing candidates targeting similar indications. One of them is vatiquinone in phase III pivotal studies for children and young adults with Friedreich ataxia developed by PTC Therapeutics.
If approved and launched commercially, omaveloxolone may face competition from PTC Therapeutics’ vatiquinone,
Reata has a pivotal-stage pipeline candidate, bardoxolone, being developed for treating chronic kidney diseases (CKD) in multiple indications. In early 2022, Reata received a complete response letter (CRL), which indicated that the FDA could not approve the NDA for bardoxolone in its present form.
Reata also has an important early-stage candidate called cemdomespib (RTA 901), the lead product candidate fromR the company's Hsp90 modulator program, in neurological indications. The company plans to begin a phase II study to evaluate cemdomespib in patients with diabetic peripheral neuropathic pain by the third quarter of 2023.
Loss per share estimates for Kala Pharmaceuticals have narrowed from $19.67 to $15.35 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. The stock has plunged 50.6% in the year-to-date period.
KALA’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Estimates for CRISPR Therapeutics' 2023 bottom line have narrowed from a loss per share of $8.21 to $7.33 in the past 60 days.
CRSP's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 3.19%. The stock has gained 6.4% in the year-to-date period.
loss per share estimates for Allogene Therapeutics have narrowed from $2.84 to $2.57 for 2023 and from $2.79 to $2.49 for 2024 in the past 60 days. The stock has plunged 9.4% in the year-to-date period.
ALLO’s earnings beat estimates in all the last four quarters, the average surprise being 8.33%.
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Reata (RETA) Stock Doubles This Year on Skyclarys FDA Nod
Reata Pharmaceuticals’ shares have more than doubled in 2023. The main reason for the surge is the approval of its Skyclarys or omaveloxolone, across a broad patient population of an ultra-rare disease named Friedreich’s ataxia on Feb 28.
Reata's shares have surged 118.4% year over year compared to the industry's 9.2% decline.
Image Source: Zacks Investment Research
The FDA approved Reata's Skyclarys (omaveloxolone) for Friedreich's ataxia in adults and adolescents aged 16 and older.
Friedreich's ataxia is an ultra-rare genetic, progressive and neurodegenerative movement disorder that affects approximately 5,000 people in the United States. This disease, usually diagnosed during adolescence, causes progressive loss of coordination, muscle weakness and fatigue, eventually resulting in loss of mobility and death.
There are no currently approved disease-modifying therapies for Friedreich's ataxia, which means Reata will enjoy the first-mover advantage for some time. Skyclarys is the first therapy explicitly indicated for treating Friedreich's ataxia. It is also Reata's first commercial product. The company expects the drug to be available commercially in the second quarter of 2023.
Although there are no currently approved therapies for Friedreich's ataxia, several companies are developing candidates targeting similar indications. One of them is vatiquinone in phase III pivotal studies for children and young adults with Friedreich ataxia developed by PTC Therapeutics.
If approved and launched commercially, omaveloxolone may face competition from PTC Therapeutics’ vatiquinone,
Reata has a pivotal-stage pipeline candidate, bardoxolone, being developed for treating chronic kidney diseases (CKD) in multiple indications. In early 2022, Reata received a complete response letter (CRL), which indicated that the FDA could not approve the NDA for bardoxolone in its present form.
Reata also has an important early-stage candidate called cemdomespib (RTA 901), the lead product candidate fromR the company's Hsp90 modulator program, in neurological indications. The company plans to begin a phase II study to evaluate cemdomespib in patients with diabetic peripheral neuropathic pain by the third quarter of 2023.
Reata Pharmaceuticals, Inc. Price and Consensus
Reata Pharmaceuticals, Inc. price-consensus-chart | Reata Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Currently, Reata has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same sector include Kala Pharmaceuticals (KALA - Free Report) and CRISPR Therapeutics (CRSP - Free Report) , both carrying a Zacks Rank #2 (Buy), and Allogene Therapeutics (ALLO - Free Report) , holding a Zacks Rank #3. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
Loss per share estimates for Kala Pharmaceuticals have narrowed from $19.67 to $15.35 for 2023 and from $14.41 to $13.12 for 2024 in the past 60 days. The stock has plunged 50.6% in the year-to-date period.
KALA’s earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 11.56%.
Estimates for CRISPR Therapeutics' 2023 bottom line have narrowed from a loss per share of $8.21 to $7.33 in the past 60 days.
CRSP's earnings beat estimates in two of the last four quarters and missed the mark in the other two, the average surprise being 3.19%. The stock has gained 6.4% in the year-to-date period.
loss per share estimates for Allogene Therapeutics have narrowed from $2.84 to $2.57 for 2023 and from $2.79 to $2.49 for 2024 in the past 60 days. The stock has plunged 9.4% in the year-to-date period.
ALLO’s earnings beat estimates in all the last four quarters, the average surprise being 8.33%.