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Roche (RHHBY) SMA Drug Gets Positive CHMP Opinion for Expanded Use
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Roche (RHHBY - Free Report) announced that its spinal muscular atrophy (SMA) drug, Evrysdi (risdiplam), has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for extended use.
The CHMP recommended extending the drug’s marketing authorization in the European Union (EU) to treat infants with SMA (from birth to below two months of age).
The positive opinion was adopted on an interim analysis of the ongoing RAINBOWFISH study, which focuses on pre-symptomatic babies with SMA type I from birth to six weeks of age.
The interim analysis showed that all the infants enrolled were able to sit independently after one year of treatment with Evrysdi. Additionally, 67% could stand and 50% could walk without any aid. Furthermore, all infants were alive at 12 months, without the need of permanent ventilation.
Evrysdi is currently approved in the EU for the treatment of SMA patients aged two months or older.
Apart from RAINBOWFISH, the drug is currently being evaluated in four other studies in SMA patients.
These studies include SUNFISH, a two-part, double-blind, placebo-controlled pivotal study in those aged 2-25 years with types II or III SMA; JEWELFISH, an open-label exploratory study designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in people with SMA aged 6 months to 60 years who received other investigational or approved SMA therapies for at least 90 days before receiving Evrysdi; and FIREFISH, an open-label, two-part pivitol study in infants with type I SMA.
MANATEE is a global phase II/III study, evaluating the safety and efficacy of GYM329, an anti-myostatin molecule targeting muscle growth, in combination with Evrysdi for the treatment of SMA in patients aged 2-10 years.
Roche’s shares have rallied 1.7% year to date compared with the industry’s growth of 3.3%.
Image Source: Zacks Investment Research
We note that Evrysdi is already a key contributor to Roche’s top line. Pharmaceuticals Division sales increased 9% in the first quarter of 2023 and Evrysdi was one of the top five contributors to this growth, apart from Vabysmo, Ocrevus (multiple sclerosis), Hemlibra (hemophilia) and Tecentriq (cancer immunotherapy).
The final decision regarding the abovementioned approval of the extension is expected from the European Commission later this year. Once approved, Evrysdi will become a vital treatment option for infants with SMA (from birth to below two months of age) in the EU, complementing its existing approval for patients aged two months or older.
In the past 90 days, the Zacks Consensus Estimate for ADC Therapeutics has widened from a loss of $2.58 per share to a loss of $2.61 for 2023. The consensus estimate has narrowed from a loss of $2.72 per share to a loss of $2.45 for 2024 during the same time frame. Shares of the company have lost 63% year to date.
ADCT’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 10.70%.
In the past 90 days, the Zacks Consensus Estimate for Acadia Pharmaceuticals has narrowed from a loss of 58 cents per share to a loss of 31 cents for 2023. Shares of the company have rallied 93.5% year to date.
ACAD’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 2.75%.
In the past 90 days, the Zacks Consensus Estimate for Akoya Biosciences has narrowed from a loss of $1.80 per share to a loss of $1.71 for 2023. The consensus estimate for Akoya Biosciences has narrowed from a loss of $1.57 per share to a loss of $1.33 for 2024 during the same time frame. Shares of the company have lost 25.5% year to date.
AKYA’s earnings missed estimates in each of the trailing four quarters, delivering an average negative surprise of 21.05%.
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Roche (RHHBY) SMA Drug Gets Positive CHMP Opinion for Expanded Use
Roche (RHHBY - Free Report) announced that its spinal muscular atrophy (SMA) drug, Evrysdi (risdiplam), has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for extended use.
The CHMP recommended extending the drug’s marketing authorization in the European Union (EU) to treat infants with SMA (from birth to below two months of age).
The positive opinion was adopted on an interim analysis of the ongoing RAINBOWFISH study, which focuses on pre-symptomatic babies with SMA type I from birth to six weeks of age.
The interim analysis showed that all the infants enrolled were able to sit independently after one year of treatment with Evrysdi. Additionally, 67% could stand and 50% could walk without any aid. Furthermore, all infants were alive at 12 months, without the need of permanent ventilation.
Evrysdi is currently approved in the EU for the treatment of SMA patients aged two months or older.
Apart from RAINBOWFISH, the drug is currently being evaluated in four other studies in SMA patients.
These studies include SUNFISH, a two-part, double-blind, placebo-controlled pivotal study in those aged 2-25 years with types II or III SMA; JEWELFISH, an open-label exploratory study designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in people with SMA aged 6 months to 60 years who received other investigational or approved SMA therapies for at least 90 days before receiving Evrysdi; and FIREFISH, an open-label, two-part pivitol study in infants with type I SMA.
MANATEE is a global phase II/III study, evaluating the safety and efficacy of GYM329, an anti-myostatin molecule targeting muscle growth, in combination with Evrysdi for the treatment of SMA in patients aged 2-10 years.
Roche’s shares have rallied 1.7% year to date compared with the industry’s growth of 3.3%.
Image Source: Zacks Investment Research
We note that Evrysdi is already a key contributor to Roche’s top line. Pharmaceuticals Division sales increased 9% in the first quarter of 2023 and Evrysdi was one of the top five contributors to this growth, apart from Vabysmo, Ocrevus (multiple sclerosis), Hemlibra (hemophilia) and Tecentriq (cancer immunotherapy).
The final decision regarding the abovementioned approval of the extension is expected from the European Commission later this year. Once approved, Evrysdi will become a vital treatment option for infants with SMA (from birth to below two months of age) in the EU, complementing its existing approval for patients aged two months or older.
Roche Holding AG Price and Consensus
Roche Holding AG price-consensus-chart | Roche Holding AG Quote
Zacks Rank and Stocks to Consider
Roche currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the same industry are ADC Therapeutics (ADCT - Free Report) , Acadia Pharmaceuticals (ACAD - Free Report) and Akoya Biosciences (AKYA - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for ADC Therapeutics has widened from a loss of $2.58 per share to a loss of $2.61 for 2023. The consensus estimate has narrowed from a loss of $2.72 per share to a loss of $2.45 for 2024 during the same time frame. Shares of the company have lost 63% year to date.
ADCT’s earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 10.70%.
In the past 90 days, the Zacks Consensus Estimate for Acadia Pharmaceuticals has narrowed from a loss of 58 cents per share to a loss of 31 cents for 2023. Shares of the company have rallied 93.5% year to date.
ACAD’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average negative surprise of 2.75%.
In the past 90 days, the Zacks Consensus Estimate for Akoya Biosciences has narrowed from a loss of $1.80 per share to a loss of $1.71 for 2023. The consensus estimate for Akoya Biosciences has narrowed from a loss of $1.57 per share to a loss of $1.33 for 2024 during the same time frame. Shares of the company have lost 25.5% year to date.
AKYA’s earnings missed estimates in each of the trailing four quarters, delivering an average negative surprise of 21.05%.