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Aerie (AERI) Up on FDA Review Committee Result for Rhopressa
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Shares of Aerie Pharmaceuticals, Inc. have moved up 15.8% in the last one week on positive news for its lead drug, Rhopressa.
In fact, Aerie’s stock has surged 71.4% year to date, compared with the industry’s gain of 3.4%.
On Oct 13, the Dermatologic and Ophthalmic Drugs Advisory Committee of the FDA voted in favor of Rhopressa’s approval. The members of the committee unanimously agreed that the trials support the efficacy of netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
In addition, majority of the members agreed that the Rhopressa’s efficacy outweigh safety risks.
The FDA has set a Prescription Drug User Fee Act date of Feb 28, 2018. We note that the FDA is not bound by the Advisory Committee’s guidance, but takes its advice into consideration when reviewing drugs.
Rhopressa is designed to lower intraocular pressure (IOP) in patients through novel mechanisms of action ( MOAs). The company believes that Rhopressa represents the first new MOAs for lowering IOP in patients with glaucoma in over 20 years.
A potential approval of the drug will significantly boost Aerie’s growth prospects. However, Rhopressa is expected to face tough competion from established branded and generic drugs like such as Novartis AG’s (NVS - Free Report) Simbrinza and Travtan, and Allergan plc’s Lumigan, as well as other smaller biotechnology and pharmaceutical companies.
Meanwhile, Aerie initiated a phase III study — Mercury 3 in Europe for its other pipeline candidate Roclatan 0.02%/0.005%. Roclatan is a once-daily, quadruple-action fixed-dose combination of Rhopressa and Pfizer’s (PFE - Free Report) Xalatan, is being evaluated to lower IOP in patients with glaucoma or ocular hypertension. The company plans to submit its NDA for the same in the first half of 2018.
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Aerie (AERI) Up on FDA Review Committee Result for Rhopressa
Shares of Aerie Pharmaceuticals, Inc. have moved up 15.8% in the last one week on positive news for its lead drug, Rhopressa.
In fact, Aerie’s stock has surged 71.4% year to date, compared with the industry’s gain of 3.4%.
On Oct 13, the Dermatologic and Ophthalmic Drugs Advisory Committee of the FDA voted in favor of Rhopressa’s approval. The members of the committee unanimously agreed that the trials support the efficacy of netarsudil ophthalmic solution for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
In addition, majority of the members agreed that the Rhopressa’s efficacy outweigh safety risks.
The FDA has set a Prescription Drug User Fee Act date of Feb 28, 2018. We note that the FDA is not bound by the Advisory Committee’s guidance, but takes its advice into consideration when reviewing drugs.
Rhopressa is designed to lower intraocular pressure (IOP) in patients through novel mechanisms of action ( MOAs). The company believes that Rhopressa represents the first new MOAs for lowering IOP in patients with glaucoma in over 20 years.
A potential approval of the drug will significantly boost Aerie’s growth prospects. However, Rhopressa is expected to face tough competion from established branded and generic drugs like such as Novartis AG’s (NVS - Free Report) Simbrinza and Travtan, and Allergan plc’s Lumigan, as well as other smaller biotechnology and pharmaceutical companies.
Meanwhile, Aerie initiated a phase III study — Mercury 3 in Europe for its other pipeline candidate Roclatan 0.02%/0.005%. Roclatan is a once-daily, quadruple-action fixed-dose combination of Rhopressa and Pfizer’s (PFE - Free Report) Xalatan, is being evaluated to lower IOP in patients with glaucoma or ocular hypertension. The company plans to submit its NDA for the same in the first half of 2018.
Zacks Rank
Aerie currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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