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Roche's (RHHBY) Lucentis 0.3 mg PFS Receives FDA Approval
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Roche Holding AG (RHHBY - Free Report) announced that the FDA has approved the Lucentis 0.3 mg prefilled syringe (“PFS”) as a new method of administering medicine for all forms of diabetic retinopathy.
We remind investors that Lucentis 0.3 mg is the first and only FDA-approved medicine to treat all forms of diabetic retinopathy in people with or without diabetic macular edema (“DME”). It was approved for this indication in April 2017.
The PFS variation is expected be available by the second quarter of 2018.
The diabetic retinopathy market has great potential as it is one of the major cause of blindness among working adults and affects nearly 7.7 million people in the United States.
Lucentis 0.5 mg PFS was also approved by the FDA in October 2016 for the treatment of neovascular (wet) age-related macular degeneration (“AMD”), macular edema following retinal vein occlusion (“RVO”) and myopic choroidal neovascularization (mCNV).
Roche has a collaboration agreement with Novartis (NVS - Free Report) for Lucentis. While Roche retains the commercial rights in the United States, Novartis has exclusive commercial rights for the rest of the world.
Lucentis is the lead drug in Roche’s ophthalmology franchise but faces stiff competition from Regeneron’s (REGN - Free Report) Eylea.
Over a year, shares of Roche have declined 6.5% against the industry’s growth of 11.5%.
Roche performance in 2017 was strong driven by contribution from newly launched drugs. The label expansion of key drugs, Perjeta, Tecentriq and Alecensa will further drive growth. Ocrevus and Hemlibra have been successfully launched and the drugs are expected to bolster the top-line further.
Roche dominates the breast cancer space with strong demand for its HER2 franchise drugs. The recently announced Ignyta acquisition will further strengthen pipeline.
Approval of new drugs and a potential label expansion of existing drugs bode well for Roche as its legacy drugs like Herceptin, MabThera are facing competition from biosimilars. Novartis has already launched its biosimilar version of Rituxan/ MabThera in Europe. Amgen (AMGN - Free Report) also obtained FDA approval for a biosimilar version of Avastin.
Earlier this month, credit bureau Equifax announced a massive data breach affecting 2 out of every 3 Americans. The cybersecurity industry is expanding quickly in response to this and similar events. But some stocks are better investments than others.
Zacks has just released Cybersecurity! An Investor’s Guide to help Zacks.com readers make the most of the $170 billion per year investment opportunity created by hackers and other threats. It reveals 4 stocks worth looking into right away.
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Roche's (RHHBY) Lucentis 0.3 mg PFS Receives FDA Approval
Roche Holding AG (RHHBY - Free Report) announced that the FDA has approved the Lucentis 0.3 mg prefilled syringe (“PFS”) as a new method of administering medicine for all forms of diabetic retinopathy.
We remind investors that Lucentis 0.3 mg is the first and only FDA-approved medicine to treat all forms of diabetic retinopathy in people with or without diabetic macular edema (“DME”). It was approved for this indication in April 2017.
The PFS variation is expected be available by the second quarter of 2018.
The diabetic retinopathy market has great potential as it is one of the major cause of blindness among working adults and affects nearly 7.7 million people in the United States.
Lucentis 0.5 mg PFS was also approved by the FDA in October 2016 for the treatment of neovascular (wet) age-related macular degeneration (“AMD”), macular edema following retinal vein occlusion (“RVO”) and myopic choroidal neovascularization (mCNV).
Roche has a collaboration agreement with Novartis (NVS - Free Report) for Lucentis. While Roche retains the commercial rights in the United States, Novartis has exclusive commercial rights for the rest of the world.
Lucentis is the lead drug in Roche’s ophthalmology franchise but faces stiff competition from Regeneron’s (REGN - Free Report) Eylea.
Over a year, shares of Roche have declined 6.5% against the industry’s growth of 11.5%.
Roche performance in 2017 was strong driven by contribution from newly launched drugs. The label expansion of key drugs, Perjeta, Tecentriq and Alecensa will further drive growth. Ocrevus and Hemlibra have been successfully launched and the drugs are expected to bolster the top-line further.
Roche dominates the breast cancer space with strong demand for its HER2 franchise drugs. The recently announced Ignyta acquisition will further strengthen pipeline.
Approval of new drugs and a potential label expansion of existing drugs bode well for Roche as its legacy drugs like Herceptin, MabThera are facing competition from biosimilars. Novartis has already launched its biosimilar version of Rituxan/ MabThera in Europe. Amgen (AMGN - Free Report) also obtained FDA approval for a biosimilar version of Avastin.
Zacks Rank
Roche carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Can Hackers Put Money INTO Your Portfolio?
Earlier this month, credit bureau Equifax announced a massive data breach affecting 2 out of every 3 Americans. The cybersecurity industry is expanding quickly in response to this and similar events. But some stocks are better investments than others.
Zacks has just released Cybersecurity! An Investor’s Guide to help Zacks.com readers make the most of the $170 billion per year investment opportunity created by hackers and other threats. It reveals 4 stocks worth looking into right away.
Download the new report now>>