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Roche (RHHBY) Receives FDA Nod for Vabysmo Prefilled Syringe
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Roche (RHHBY - Free Report) obtained FDA approval for a single-dose prefilled syringe (PFS) of ophthalmology drug Vabysmo (faricimab) for three main causes of vision loss.
The PFS has been approved for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).
The PFS delivers the same drug as the currently available Vabysmo vials in an alternative, ready-to-use format. It has been designed to simplify administration.
Vabysmo is the first and only bispecific antibody approved for the eye. It targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Vabysmo has put a stellar performance.
The drug is already approved in several countries for the aforementioned indications, and review by other health authorities across the globe is ongoing.
Roche’s shares have lost 5.8% year to date against the industry’s growth of 19.7%.
Image Source: Zacks Investment Research
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recently recommended a label expansion of Vabysmo for the treatment of visual impairment due to macular edema secondary to RVO.
The European Commission is expected to give a final decision shortly.
Roche’s ophthalmology portfolio also comprises Susvimo and Lucentis. Susvimo (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant was approved by the FDA in 2021.
Approval of new drugs and label expansion of the existing ones should bode well for Roche. Drugs like Vabysmo, Ocrevus, Hemlibra and Polivy fuel Roche’s top line as the company looks to fill up the dent in revenues caused by a decline in COVID-19-related sales. Competition from biosimilars for established drugs like Avastin, MabThera/Rituxan and Herceptin continues to hurt sales.
Sales of Regeneron’s (REGN - Free Report) blockbuster ophthalmology drug Eylea have been under pressure due to competition from Vabysmo.
To counter the decline in Eylea sales, Regeneron developed a higher dose of the drug. The initial uptake of Eylea HD is encouraging as Eylea patients transition to the higher dose.
In the past 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73.
ALX Oncology beat on earnings in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has remained constant at 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.
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Roche (RHHBY) Receives FDA Nod for Vabysmo Prefilled Syringe
Roche (RHHBY - Free Report) obtained FDA approval for a single-dose prefilled syringe (PFS) of ophthalmology drug Vabysmo (faricimab) for three main causes of vision loss.
The PFS has been approved for use in the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO).
The PFS delivers the same drug as the currently available Vabysmo vials in an alternative, ready-to-use format. It has been designed to simplify administration.
Vabysmo is the first and only bispecific antibody approved for the eye. It targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Vabysmo has put a stellar performance.
The drug is already approved in several countries for the aforementioned indications, and review by other health authorities across the globe is ongoing.
Roche’s shares have lost 5.8% year to date against the industry’s growth of 19.7%.
Image Source: Zacks Investment Research
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recently recommended a label expansion of Vabysmo for the treatment of visual impairment due to macular edema secondary to RVO.
The European Commission is expected to give a final decision shortly.
Roche’s ophthalmology portfolio also comprises Susvimo and Lucentis. Susvimo (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant was approved by the FDA in 2021.
Approval of new drugs and label expansion of the existing ones should bode well for Roche. Drugs like Vabysmo, Ocrevus, Hemlibra and Polivy fuel Roche’s top line as the company looks to fill up the dent in revenues caused by a decline in COVID-19-related sales. Competition from biosimilars for established drugs like Avastin, MabThera/Rituxan and Herceptin continues to hurt sales.
Sales of Regeneron’s (REGN - Free Report) blockbuster ophthalmology drug Eylea have been under pressure due to competition from Vabysmo.
To counter the decline in Eylea sales, Regeneron developed a higher dose of the drug. The initial uptake of Eylea HD is encouraging as Eylea patients transition to the higher dose.
Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the healthcare sector are ALX Oncology Holdings (ALXO - Free Report) and Compugen (CGEN - 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 30 days, the Zacks Consensus Estimate for ALX Oncology’s 2024 loss per share has remained constant at $2.89. During the same period, the consensus estimate for 2025 loss per share has remained constant at $2.73.
ALX Oncology beat on earnings in two of the trailing four quarters and missed twice, delivering an average negative surprise of 8.83%.
In the past 30 days, the Zacks Consensus Estimate for Compugen’s 2024 earnings per share has remained constant at 5 cents. The consensus estimate for 2025 loss per share is currently pegged at 11 cents.
CGEN’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 5.79%.