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Aerie's (AERI) Rhopressa NDA Sufficient for FDA Review
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Aerie Pharmaceuticals, Inc. announced that it has received notification from the FDA about the completion of the initial 60-day review of the new drug application (NDA) for Rhopressa. The FDA determined that the application is sufficiently complete and can undergo a substantive review. Concurrently, the Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA’s review has been set on Feb 28, 2018.
We note that Aerie has outperformed the Zacks classified Medical Drugs industry in the last 12 months. In fact, the stock rallied 191.4% during this period, compared with the industry’s 17.2% gain.
The acceptance indicates that the FDA has not identified any potential review issues. The FDA is currently planning to hold an advisory committee.
We note that Rhopressa is Aerie’s lead candidate. Rhopressa is a once-daily formulation for intraocular pressure (IOP) in patients suffering from open-angle glaucoma and ocular hypertension. Aerie filed a NDA for the drug in the U.S. in Sep 2016. However, in Oct 2016, the company withdrew the NDA due to the failure of a third-party manufacturing facility not ready for pre-approval inspection. The company resubmitted its NDA in Feb 2017.
Hence, a potential approval and successful commercialization will boost the company’s growth prospects in the global ophthalmic market significantly.
Currently, Rhopressa is being evaluated in two phase III registration studies – the Rocket 4 study (six-month data expected in the second quarter of 2017), designed to gain adequate safety data for regulatory filings in EU and the Rocket 3 study, a 12-month, safety-only study for regulatory filings in Canada. Aerie expects to submit regulatory application for Rhopressa in the EU in the second half of 2017.
Apart from Rhopressa, Aerie is evaluating Roclatan, a once-daily, quadruple-action fixed-dose combination of Rhopressa and Pfizer’s (PFE - Free Report) Xalatan. The company expects top-line 90-day efficacy and safety data from the second phase III clinical trial, Mercury 2, for Roclatan 0.02%/0.005%, in the second quarter of 2017. Data from Mercury 1 is expected in the third quarter of 2017. If Mercury 1 and Mercury 2 are successful, the NDA for Roclatan is expected to be filed in late 2017 or early 2018.
The company also expects to commence a trial, Mercury 3, in mid-2017, in Europe to support filings there. The trial will be a non-inferiority trial comparing Roclatan to prescribed fixed dose combination of Ganfort (a combination of the bimatoprost along with timolol), marketed by Allergan in Europe.
VIVUS’ loss per share estimates narrowed from 502 cents to 39 cents for 2017 over the last 60 days. The company posted positive earnings surprises in all of the four trailing quarters, with an average beat of 233.69%.
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Aerie's (AERI) Rhopressa NDA Sufficient for FDA Review
Aerie Pharmaceuticals, Inc. announced that it has received notification from the FDA about the completion of the initial 60-day review of the new drug application (NDA) for Rhopressa. The FDA determined that the application is sufficiently complete and can undergo a substantive review. Concurrently, the Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA’s review has been set on Feb 28, 2018.
We note that Aerie has outperformed the Zacks classified Medical Drugs industry in the last 12 months. In fact, the stock rallied 191.4% during this period, compared with the industry’s 17.2% gain.
The acceptance indicates that the FDA has not identified any potential review issues. The FDA is currently planning to hold an advisory committee.
We note that Rhopressa is Aerie’s lead candidate. Rhopressa is a once-daily formulation for intraocular pressure (IOP) in patients suffering from open-angle glaucoma and ocular hypertension. Aerie filed a NDA for the drug in the U.S. in Sep 2016. However, in Oct 2016, the company withdrew the NDA due to the failure of a third-party manufacturing facility not ready for pre-approval inspection. The company resubmitted its NDA in Feb 2017.
Hence, a potential approval and successful commercialization will boost the company’s growth prospects in the global ophthalmic market significantly.
Currently, Rhopressa is being evaluated in two phase III registration studies – the Rocket 4 study (six-month data expected in the second quarter of 2017), designed to gain adequate safety data for regulatory filings in EU and the Rocket 3 study, a 12-month, safety-only study for regulatory filings in Canada. Aerie expects to submit regulatory application for Rhopressa in the EU in the second half of 2017.
Apart from Rhopressa, Aerie is evaluating Roclatan, a once-daily, quadruple-action fixed-dose combination of Rhopressa and Pfizer’s (PFE - Free Report) Xalatan. The company expects top-line 90-day efficacy and safety data from the second phase III clinical trial, Mercury 2, for Roclatan 0.02%/0.005%, in the second quarter of 2017. Data from Mercury 1 is expected in the third quarter of 2017. If Mercury 1 and Mercury 2 are successful, the NDA for Roclatan is expected to be filed in late 2017 or early 2018.
The company also expects to commence a trial, Mercury 3, in mid-2017, in Europe to support filings there. The trial will be a non-inferiority trial comparing Roclatan to prescribed fixed dose combination of Ganfort (a combination of the bimatoprost along with timolol), marketed by Allergan in Europe.
Zacks Rank & Key Pick
Aerie currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the healthcare sector is VIVUS, Inc. which currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
VIVUS’ loss per share estimates narrowed from 502 cents to 39 cents for 2017 over the last 60 days. The company posted positive earnings surprises in all of the four trailing quarters, with an average beat of 233.69%.
5 Trades Could Profit "Big-League" from Trump Policies
If the stocks above spark your interest, wait until you look into companies primed to make substantial gains from Washington's changing course.
Today Zacks reveals 5 tickers that could benefit from new trends like streamlined drug approvals, tariffs, lower taxes, higher interest rates, and spending surges in defense and infrastructure. See these buy recommendations now >>