Shares of Wave Lifesciences (WVE - Free Report) were up 8.26% on Sep 20, after the company announced a positive update from its ongoing phase Ib/IIa SELECT-HD study on its clinical candidate, WVE-009 for treating Huntington’s disease (HD).
Wave Therapeutics’ shares have returned 16.9% in the year-to-date period against the industry’s decline of 16.9%.
Huntington’s disease is a debilitating and fatal autosomal dominant neurological disorder that causes nerve cells in the brain to deteriorate over time. The disease causes cognitive decline, psychiatric illness and chorea. There are currently no approved disease-modifying therapies for Huntington’s.
WVE-003 is an antisense oligonucleotide being developed for HD, which lowers the expression of the disease-causing mutant huntingtin (“mHTT”) protein in the subject by selectively targeting an undisclosed single nucleotide polymorphism (“SNP”), mHTT SNP3. The process keeps the wild-type (healthy) huntingtin (“wtHTT”) protein intact, which is important for neuronal function.
The SELECT-HD study is a randomized, double-blind, placebo-controlled phase Ib/IIa clinical study evaluating the safety and tolerability of intrathecally administered WVE-003 in patients with early manifest HD.
The data from the study showed that the mHTT protein in the cerebrospinal fluid was reduced in subjects, after receiving either a 30mg dose of a 60mg dose of WVE-003.
Eighteen patients were dosed in the SELECT-HD study in three dose cohorts, namely 30mg, 60 mg and 90 mg of WVE-003.
Subjects in the 30 mg and 60 mg dose cohorts of WVE-003 observed a mean reduction of 22% (median reduction of 30%) in CSF mHTT from the baseline at day 85, following a single dose of WVE-003. This shows a compelling pharmacological profile of the candidate for individuals with HD. In these two doses, wtHTT protein was also preserved.
Though increases in neurofilament light chain (NfL) from baseline were observed in some subjects, it was not clinically meaningful.
Overall safety and tolerability were observed in patients receiving single doses of WVE-003 up to 90 mg. No serious adverse effects were observed in the subjects.
Based on this update, Wave plans to expand the single-dose cohorts of the SELECT-HD study tooptimize dose levels and will continue to advance the 90 mg cohort for biomarker analysis.
The company intends to release additional single-dose biomarkers and safety data in the first half of 2023.
Zacks Rank and Stocks to Consider
Wave Therapeutics currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same sector include Sesen Bio , carrying a Zacks Rank #1 (Strong Buy) and Aridis Pharmaceuticals (ARDS - Free Report) and Satsuma Pharmaceuticals , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sesen Bio’s loss per share estimates for 2022 widened from 31 cents to 43 cents in the past 30 days. The same for 2023 has narrowed from 10 cents to a cent in the same time frame.
Earnings of Sesen Bio missed estimates in all of the trailing four quarters. The average negative earnings surprise for SESN is 89.49%.
Aridis Pharmaceuticals' loss estimates for 2022 have narrowed to 23 cents from a loss of 30 cents in the past 30 days. The loss estimates for 2023 also narrowed down from 58 cents per share to 53 cents per share in the same time frame.
ARDS surpassed earnings in three of the trailing four quarters, missing the same in one. The average negative earnings surprise for Aridis is 238.54%.
Satsuma’s loss per share estimates for 2022 widened from $1.88 to $1.97 in the past 30 days. The loss per share for 2023 has widened from 98 cents to $1.50 in the same time frame.
Earnings of Satsuma beat estimates in three of the trailing four quarters, while missing the same in one. The average negative earnings surprise for STSA is 0.54%.
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With strong earnings growth and an expanding customer base, it's positioned to feed the rampant demand for Artificial Intelligence, Machine Learning, and Internet of Things. Global semiconductor manufacturing is projected to explode from $452 billion in 2021 to $803 billion by 2028.
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Shares of Wave Lifesciences (WVE - Free Report) were up 8.26% on Sep 20, after the company announced a positive update from its ongoing phase Ib/IIa SELECT-HD study on its clinical candidate, WVE-009 for treating Huntington’s disease (HD).
Wave Therapeutics’ shares have returned 16.9% in the year-to-date period against the industry’s decline of 16.9%.
Huntington’s disease is a debilitating and fatal autosomal dominant neurological disorder that causes nerve cells in the brain to deteriorate over time. The disease causes cognitive decline, psychiatric illness and chorea. There are currently no approved disease-modifying therapies for Huntington’s.
WVE-003 is an antisense oligonucleotide being developed for HD, which lowers the expression of the disease-causing mutant huntingtin (“mHTT”) protein in the subject by selectively targeting an undisclosed single nucleotide polymorphism (“SNP”), mHTT SNP3. The process keeps the wild-type (healthy) huntingtin (“wtHTT”) protein intact, which is important for neuronal function.
The SELECT-HD study is a randomized, double-blind, placebo-controlled phase Ib/IIa clinical study evaluating the safety and tolerability of intrathecally administered WVE-003 in patients with early manifest HD.
The data from the study showed that the mHTT protein in the cerebrospinal fluid was reduced in subjects, after receiving either a 30mg dose of a 60mg dose of WVE-003.
Eighteen patients were dosed in the SELECT-HD study in three dose cohorts, namely 30mg, 60 mg and 90 mg of WVE-003.
Subjects in the 30 mg and 60 mg dose cohorts of WVE-003 observed a mean reduction of 22% (median reduction of 30%) in CSF mHTT from the baseline at day 85, following a single dose of WVE-003. This shows a compelling pharmacological profile of the candidate for individuals with HD. In these two doses, wtHTT protein was also preserved.
Though increases in neurofilament light chain (NfL) from baseline were observed in some subjects, it was not clinically meaningful.
Overall safety and tolerability were observed in patients receiving single doses of WVE-003 up to 90 mg. No serious adverse effects were observed in the subjects.
Based on this update, Wave plans to expand the single-dose cohorts of the SELECT-HD study tooptimize dose levels and will continue to advance the 90 mg cohort for biomarker analysis.
The company intends to release additional single-dose biomarkers and safety data in the first half of 2023.
Zacks Rank and Stocks to Consider
Wave Therapeutics currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same sector include Sesen Bio , carrying a Zacks Rank #1 (Strong Buy) and Aridis Pharmaceuticals (ARDS - Free Report) and Satsuma Pharmaceuticals , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sesen Bio’s loss per share estimates for 2022 widened from 31 cents to 43 cents in the past 30 days. The same for 2023 has narrowed from 10 cents to a cent in the same time frame.
Earnings of Sesen Bio missed estimates in all of the trailing four quarters. The average negative earnings surprise for SESN is 89.49%.
Aridis Pharmaceuticals' loss estimates for 2022 have narrowed to 23 cents from a loss of 30 cents in the past 30 days. The loss estimates for 2023 also narrowed down from 58 cents per share to 53 cents per share in the same time frame.
ARDS surpassed earnings in three of the trailing four quarters, missing the same in one. The average negative earnings surprise for Aridis is 238.54%.
Satsuma’s loss per share estimates for 2022 widened from $1.88 to $1.97 in the past 30 days. The loss per share for 2023 has widened from 98 cents to $1.50 in the same time frame.
Earnings of Satsuma beat estimates in three of the trailing four quarters, while missing the same in one. The average negative earnings surprise for STSA is 0.54%.
Zacks Names #1 Semiconductor Stock
It's only 1/9,000th the size of NVIDIA which skyrocketed more than +800% since we recommended it. NVIDIA is still strong, but our new top chip stock has much more room to boom.
With strong earnings growth and an expanding customer base, it's positioned to feed the rampant demand for Artificial Intelligence, Machine Learning, and Internet of Things. Global semiconductor manufacturing is projected to explode from $452 billion in 2021 to $803 billion by 2028.
See This Stock Now for Free >>
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