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WVE Stock Soars on Upbeat Efficacy Data From Muscle Disease Study
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Shares of Wave Life Sciences (WVE - Free Report) surged 53.4% on Tuesday after the company announced positive interim data from a mid-stage study evaluating its investigational candidate, WVE-N531, to treat boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping.
WVE-N531, an exon skipping oligonucleotide, is currently being developed as a disease-modifying treatment for DMD indication in boys. The candidate enjoys the FDA’s Orphan Drug and Rare Pediatric Disease designations in the United States for the same indication.
The data readout is from the planned interim analysis of the phase II FORWARD-53 study after 24 weeks, where the DMD patients received a 10 mg/kg dose of WVE-N531 every two weeks. Per Wave Life Sciences, treatment with the candidate demonstrated substantial dystrophin expression and was generally safe and overall well tolerated.
WVE expects to share 48-week data from the complete FORWARD-53 study of WVE-N531 for DMD in the first quarter of 2025 and receive feedback from regulators on a pathway to accelerated approval.
Year to date, WVE shares have rallied 62.2% against the industry’s 1.5% decline.
Image Source: Zacks Investment Research
WVE’s DMD Drug Demonstrates Superior Efficacy
Per the interim data readout from the mid-stage study, treatment with WVE-N531 for 24 weeks resulted in a mean muscle content-adjusted dystrophin expression of 9% and unadjusted dystrophin of 5.5%. Per management, such high and consistent dystrophin levels underscore the potential of the candidate to treat boys with DMD who are amenable to exon 53 skipping, where there is a high unmet medical need.
Please note that dystrophin is expressed in multiple functional isoforms. The interesting fact is that the two isoforms observed in the interim data readout from the DMD study are consistent with Becker muscular dystrophy patients who display milder disease. Additionally, Wave Life Sciences reported that 89% of ambulatory participants achieved muscle content-adjusted dystrophin levels of at least 5%.
Apart from favorable dystrophin expression, treatment with WVE-N531 for 24 weeks also resulted in myofiber regeneration and improvements in muscle health. The interim data readout also showed significant decreases in creatine kinase and aspartate aminotransferaselevels from baseline, signifying meaningful improvement in muscle health.
Wave Life Sciences also reported that skeletal muscle concentrations of ~41,000 ng/g combined with 61-day tissue half-life support monthly dosing of the candidate going forward, which will further reduce the treatment burden of DMD patients.
Treatment-related adverse events were mostly mild in intensity, with no oligonucleotide class-related safety events.
WVE’s Pipeline Programs Beyond DMD
Apart from the DMD indication, there are several other candidates like WVE-006, WVE-003 and WVE-007 in Wave Life Sciences’ pipeline that are being developed for rare and prevalent diseases, including alpha-1 antitrypsin deficiency (AATD), Huntington’s disease and obesity, respectively.
While the obesity candidate is currently in the preclinical stage, WVE-006 and WVE-003 are currently undergoing mid-stage clinical development for their respective indications. Wave Life Sciences currently anticipates reporting proof-of-mechanism data from its phase Ib/IIa RestorAATion-2 study evaluating WVE-006 for AATD in the fourth quarter of 2024.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 6.1%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $2.09 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have jumped 44.7%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 52.4%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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WVE Stock Soars on Upbeat Efficacy Data From Muscle Disease Study
Shares of Wave Life Sciences (WVE - Free Report) surged 53.4% on Tuesday after the company announced positive interim data from a mid-stage study evaluating its investigational candidate, WVE-N531, to treat boys with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping.
WVE-N531, an exon skipping oligonucleotide, is currently being developed as a disease-modifying treatment for DMD indication in boys. The candidate enjoys the FDA’s Orphan Drug and Rare Pediatric Disease designations in the United States for the same indication.
The data readout is from the planned interim analysis of the phase II FORWARD-53 study after 24 weeks, where the DMD patients received a 10 mg/kg dose of WVE-N531 every two weeks. Per Wave Life Sciences, treatment with the candidate demonstrated substantial dystrophin expression and was generally safe and overall well tolerated.
WVE expects to share 48-week data from the complete FORWARD-53 study of WVE-N531 for DMD in the first quarter of 2025 and receive feedback from regulators on a pathway to accelerated approval.
Year to date, WVE shares have rallied 62.2% against the industry’s 1.5% decline.
Image Source: Zacks Investment Research
WVE’s DMD Drug Demonstrates Superior Efficacy
Per the interim data readout from the mid-stage study, treatment with WVE-N531 for 24 weeks resulted in a mean muscle content-adjusted dystrophin expression of 9% and unadjusted dystrophin of 5.5%. Per management, such high and consistent dystrophin levels underscore the potential of the candidate to treat boys with DMD who are amenable to exon 53 skipping, where there is a high unmet medical need.
Please note that dystrophin is expressed in multiple functional isoforms. The interesting fact is that the two isoforms observed in the interim data readout from the DMD study are consistent with Becker muscular dystrophy patients who display milder disease. Additionally, Wave Life Sciences reported that 89% of ambulatory participants achieved muscle content-adjusted dystrophin levels of at least 5%.
Apart from favorable dystrophin expression, treatment with WVE-N531 for 24 weeks also resulted in myofiber regeneration and improvements in muscle health. The interim data readout also showed significant decreases in creatine kinase and aspartate aminotransferaselevels from baseline, signifying meaningful improvement in muscle health.
Wave Life Sciences also reported that skeletal muscle concentrations of ~41,000 ng/g combined with 61-day tissue half-life support monthly dosing of the candidate going forward, which will further reduce the treatment burden of DMD patients.
Treatment-related adverse events were mostly mild in intensity, with no oligonucleotide class-related safety events.
WVE’s Pipeline Programs Beyond DMD
Apart from the DMD indication, there are several other candidates like WVE-006, WVE-003 and WVE-007 in Wave Life Sciences’ pipeline that are being developed for rare and prevalent diseases, including alpha-1 antitrypsin deficiency (AATD), Huntington’s disease and obesity, respectively.
While the obesity candidate is currently in the preclinical stage, WVE-006 and WVE-003 are currently undergoing mid-stage clinical development for their respective indications. Wave Life Sciences currently anticipates reporting proof-of-mechanism data from its phase Ib/IIa RestorAATion-2 study evaluating WVE-006 for AATD in the fourth quarter of 2024.
WAVE Life Sciences Ltd. Price and Consensus
WAVE Life Sciences Ltd. price-consensus-chart | WAVE Life Sciences Ltd. Quote
Zacks Rank & Stocks to Consider
Wave Life Sciences currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 6.1%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $2.09 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have jumped 44.7%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 52.4%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.