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Aerie (AERI) Rhopressa Regulatory Application Delayed Again

Aerie Pharmaceuticals, Inc.AERI announced that the manufacturing facility for its lead candidate Rhopressa will not be ready for pre-approval inspection by the FDA until the end of Feb 2017.

We note that Aerie has outperformed the Zacks classified Medical Drugs industry in the last three months. In fact, the stock has lost 1.3% during this period, compared with a drop of 9.7% for the industry.

The company was notified by its third-party manufacturer that the manufacturing line related to Rhopressa in the Tampa, FL facility will not be ready before February.

We remind investors that Aerie had withdrawn its New Drug Application (NDA) for Rhopressa as the contract drug product manufacturer was not prepared for a pre-approval inspection by the FDA in Oct 2016. The contract drug product manufacturer had previously informed Aerie and the FDA that would be prepared for the FDA inspection in Jan 2017.

The manufacturer has, however, clarified that the delay is not a result of any new finding, but the additional time needed to complete the validation of new equipment.

Rhopressa is a once-daily formulation for intraocular pressure (IOP) in patients suffering from open-angle glaucoma and ocular hypertension.

Aerie expects to resubmit the NDA for Rhopressa around the end of the first quarter of 2017, after it receives a notification from the contract drug product manufacturer that the manufacturing line related to the candidate at the Tampa, FL site is ready for inspection.

The delay in the NDA filing is quite disappointing as Rhopressa is Aerie's lead late-stage candidate.

We note that the NDA included results of two phase III studies - Rocket 2 and Rocket 1. While Rocket 2 will represent the pivotal trial and Rocket 1 will be supportive. Meanwhile, two additional phase III registration trials - Rocket 3 and Rocket 4 - on Rhopressa are underway. While Rocket 3 is a 12-month safety-only study in Canada, Rocket 4 will provide adequate six-month safety data for regulatory filing purposes in Europe. However, data from neither of the two studies are needed for the NDA filing.

Aerie's second candidate, Roclatan is a fixed-dose combination of Rhopressa and Pfizer's PFE Xalatan. Two phase III registration trials on the combination is currently underway - Mercury 1 and Mercury 2. If the trials are successful, an NDA filing is expected to take place around the end of 2017.

AERIE PHARMACT Price and Consensus

AERIE PHARMACT Price and Consensus | AERIE PHARMACT Quote

Aerie currently carries a Zacks Rank #3 (Hold).

Key Picks in the Sector

A couple of better-ranked stocks in the health care sector include Heska Corp. HSKA , and Vanda Pharmaceuticals VNDA . Both of them sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here.

Heska's earnings estimates increased from $1.13 to $1.35 for 2016 and from $1.38 to $1.53 for 2017 over the last 60 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 301.64%. Its share price has increased 86.6% year to date.

Vanda's loss estimates for 2016 narrowed from 62 cents to 45 cents, while its earnings estimates for 2017 decreased from 13 cents to 9 cents over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 56.65%. Its share price has surged almost 72.9% year to date.

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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