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Novartis (NVS) Beovu Gets Label Expansion for DME in EU
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Novartis (NVS - Free Report) recently announced that the European Commission (“EC”) has approved a label expansion of its ophthalmology drug Beovu (brolucizumab).
The EC approved Beovu for the treatment of visual impairment due to diabetic macular edema (DME). This the second indication for which the drug has been approved in the European Union.
Beovu was approved for the treatment of wet age-related macular degeneration in 2020.
DME is a common microvascular complication in patients with diabetes that may have a debilitating impact on visual acuity.
The approval was based on year one data from the phase III, randomized, double-masked KESTREL and KITE studies evaluating Beovu 6 mg versus Regeneron’s (REGN - Free Report) Eylea (aflibercept) in DME patients. Beovu was non-inferior to Eylea in change in best-corrected visual acuity (BCVA) from baseline and showed potential for fluid resolution in numerically more DME patients.
Per the companies, KESTREL and KITE were the first pivotal trials to assess an anti-VEGF on six-week dosing intervals in the loading phase, suggesting Beovu may offer fewer injections from the start of treatment through year one.
Beovu is also under review for the DME indication in the United States.
Meanwhile, additional studies evaluating the impact of brolucizumab in patients with wet AMD, DME and proliferative diabetic retinopathy (PDR) are ongoing.
Regeneron’s key growth driver, Eylea, continues to generate revenues for the company on consistent label expansions. It is approved for wet AMD, DME and macular edema following retinal vein occlusion, including macular edema following central retinal vein occlusion and macular edema following branch retinal vein occlusion. Regeneron is working on expanding the drug’s label into additional indications, which will further boost sales.
Approval of new drugs and label expansion of existing drugs are likely to boost Novartis’ top line in the days to come.
Shares of Novartis have gained 0.3% so far this year compared with the industry’s growth of 4.1%.
Image Source: Zacks Investment Research
The FDA recently approved Novartis’ targeted radioligand therapy, Pluvicto, for the treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer.
Novartis has a strong and diverse portfolio. Solid momentum in key brands like psoriasis drug Cosentyx, cardiovascular drug Entresto, gene therapy Zolgensma, the oncology portfolio and the launch of Kesimpta continue to boost performance.
Novartis has streamlined its business significantly and is looking forward to focusing on its core business. NVS is still evaluating whether to retain or sell its generic business and expects to provide an update on the same by the end of this year.
Novartis currently carries a Zacks Rank #4 (Sell).
The consensus estimate for Vertex’s 2022 earnings has increased 19 cents over the past 60 days to $14.52. Shares of VRTX have gained 18.8% in the year so far.
Loss estimates for KLDO have narrowed to $1.64 from $2.13 for 2022 in the past 60 days. Earnings of Kaleido Biosciences surpassed estimates in three of the trailing four quarters and missed the same once.
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Novartis (NVS) Beovu Gets Label Expansion for DME in EU
Novartis (NVS - Free Report) recently announced that the European Commission (“EC”) has approved a label expansion of its ophthalmology drug Beovu (brolucizumab).
The EC approved Beovu for the treatment of visual impairment due to diabetic macular edema (DME). This the second indication for which the drug has been approved in the European Union.
Beovu was approved for the treatment of wet age-related macular degeneration in 2020.
DME is a common microvascular complication in patients with diabetes that may have a debilitating impact on visual acuity.
The approval was based on year one data from the phase III, randomized, double-masked KESTREL and KITE studies evaluating Beovu 6 mg versus Regeneron’s (REGN - Free Report) Eylea (aflibercept) in DME patients. Beovu was non-inferior to Eylea in change in best-corrected visual acuity (BCVA) from baseline and showed potential for fluid resolution in numerically more DME patients.
Per the companies, KESTREL and KITE were the first pivotal trials to assess an anti-VEGF on six-week dosing intervals in the loading phase, suggesting Beovu may offer fewer injections from the start of treatment through year one.
Beovu is also under review for the DME indication in the United States.
Meanwhile, additional studies evaluating the impact of brolucizumab in patients with wet AMD, DME and proliferative diabetic retinopathy (PDR) are ongoing.
Regeneron’s key growth driver, Eylea, continues to generate revenues for the company on consistent label expansions. It is approved for wet AMD, DME and macular edema following retinal vein occlusion, including macular edema following central retinal vein occlusion and macular edema following branch retinal vein occlusion. Regeneron is working on expanding the drug’s label into additional indications, which will further boost sales.
Approval of new drugs and label expansion of existing drugs are likely to boost Novartis’ top line in the days to come.
Shares of Novartis have gained 0.3% so far this year compared with the industry’s growth of 4.1%.
Image Source: Zacks Investment Research
The FDA recently approved Novartis’ targeted radioligand therapy, Pluvicto, for the treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer.
Novartis has a strong and diverse portfolio. Solid momentum in key brands like psoriasis drug Cosentyx, cardiovascular drug Entresto, gene therapy Zolgensma, the oncology portfolio and the launch of Kesimpta continue to boost performance.
Novartis has streamlined its business significantly and is looking forward to focusing on its core business. NVS is still evaluating whether to retain or sell its generic business and expects to provide an update on the same by the end of this year.
Novartis currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the healthcare space are Vertex Pharmaceuticals (VRTX - Free Report) and Kaleido Biosciences , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The consensus estimate for Vertex’s 2022 earnings has increased 19 cents over the past 60 days to $14.52. Shares of VRTX have gained 18.8% in the year so far.
Loss estimates for KLDO have narrowed to $1.64 from $2.13 for 2022 in the past 60 days. Earnings of Kaleido Biosciences surpassed estimates in three of the trailing four quarters and missed the same once.