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Roche's (RHHBY) Lucentis Gets FDA Nod for Fifth Indication
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Roche Holding AG (RHHBY - Free Report) announced today that the FDA has approved a label expansion of ophthalmology drug Lucentis.
Notably, Roche has underperformed the Zacks classified Large Cap Pharmaceuticals industry in the last twelve months. In fact, the stock has lost 10.9% in the last twelve months, compared with a drop of 1.0% for the industry
The FDA approved Lucentis 0.5 mg for the treatment of patients with myopic choroidal neovascularization (mCNV). This is the fifth indication for which Lucentis obtained FDA approval.
We remind investors that Lucentis is already approved in the U.S. for the treatment of patients with wet age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) in people with DME and myopic choroidal neovascularization (mCNV).
Notably, Roche has a collaboration agreement with Novartis (NVS - Free Report) for Lucentis. While Roche retains the commercial rights for the drug in the U.S, Novartis has exclusive commercial rights for the same throughout the world.
Lucentis generated sales of CHF1.1 billion in the first nine months of 2016, down 8% from the same period in 2015. This has been a result of the drug’s sales being continuously impacted by competition. However, Roche expects the decline to moderate in the coming quarters.
We note that Regeneron Pharmaceuticals, Inc. (REGN - Free Report) ’s Eylea is also approved for the treatment of neovascular wet AMD, diabetic DME, RVO, which includes macular edema following central retinal vein occlusion (CRVO) and macular edema following branch retinal vein occlusion (BRVO) in the U.S.
In Oct 2016, the FDA approved the Lucentis prefilled syringe as a new method of administering the medicine to patients suffering from wet age-related macular degeneration and to patients with macular edema after retinal vein occlusion.
A label expansion of the drug should boost sales and somewhat offset the impact of competition.
Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space with strong demand for its HER2 franchise drugs. The HER2 franchise includes Herceptin, Perjeta and Kadcyla. Roche is making efforts to develop its portfolio beyond oncology into immunology and ophthalmology as well.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 90 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 31.2% in the last twelve months.
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Roche's (RHHBY) Lucentis Gets FDA Nod for Fifth Indication
Roche Holding AG (RHHBY - Free Report) announced today that the FDA has approved a label expansion of ophthalmology drug Lucentis.
Notably, Roche has underperformed the Zacks classified Large Cap Pharmaceuticals industry in the last twelve months. In fact, the stock has lost 10.9% in the last twelve months, compared with a drop of 1.0% for the industry
The FDA approved Lucentis 0.5 mg for the treatment of patients with myopic choroidal neovascularization (mCNV). This is the fifth indication for which Lucentis obtained FDA approval.
We remind investors that Lucentis is already approved in the U.S. for the treatment of patients with wet age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) in people with DME and myopic choroidal neovascularization (mCNV).
Notably, Roche has a collaboration agreement with Novartis (NVS - Free Report) for Lucentis. While Roche retains the commercial rights for the drug in the U.S, Novartis has exclusive commercial rights for the same throughout the world.
Lucentis generated sales of CHF1.1 billion in the first nine months of 2016, down 8% from the same period in 2015. This has been a result of the drug’s sales being continuously impacted by competition. However, Roche expects the decline to moderate in the coming quarters.
We note that Regeneron Pharmaceuticals, Inc. (REGN - Free Report) ’s Eylea is also approved for the treatment of neovascular wet AMD, diabetic DME, RVO, which includes macular edema following central retinal vein occlusion (CRVO) and macular edema following branch retinal vein occlusion (BRVO) in the U.S.
In Oct 2016, the FDA approved the Lucentis prefilled syringe as a new method of administering the medicine to patients suffering from wet age-related macular degeneration and to patients with macular edema after retinal vein occlusion.
A label expansion of the drug should boost sales and somewhat offset the impact of competition.
Roche has a strong presence in the oncology market. In particular, the company dominates the breast cancer space with strong demand for its HER2 franchise drugs. The HER2 franchise includes Herceptin, Perjeta and Kadcyla. Roche is making efforts to develop its portfolio beyond oncology into immunology and ophthalmology as well.
ROCHE HLDG LTD Price and Consensus
ROCHE HLDG LTD Price and Consensus | ROCHE HLDG LTD Quote
Roche currently carries a Zacks Rank #4 (Sell).
Key Pick in the Sector
Cambrex Corp. sports a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 90 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 31.2% in the last twelve months.
The Best Place to Start Your Stock Search
Today, you are invited to download the full list of 220 Zacks Rank #1 "Strong Buy" stocks – absolutely free of charge. Since 1988, Zacks Rank #1 stocks have nearly tripled the market, with average gains of +26% per year. Plus, you can access the list of portfolio-killing Zacks Rank #5 "Strong Sells" and other private research. See these stocks free >>