Mizuho Securities USA LLC has reiterated its ‘Buy’ rating and price target of $70 on shares of Aerie Pharmaceuticals, Inc.’s (NASDAQ: AERI) stock. The analyst noted the FDA’s recently reported date of the Advisory Committee for Aerie Pharmaceutical’s Rhopressa to take place on October 13, 2017. This meeting is considered routine to take place before approval of a new product, specifically a new molecular entity. The analyst also noted another key date to remember in regards to the FDA meeting: October 11, the anticipated date that the FDA will release the background information on Rhopressa. This document typically offers a hint as to whether or not the FDA has any major concerns on efficacy, safety of the compound or the rigor of statistical analysis.
For more information, visit: www.AeriePharma.com
About Aerie Pharmaceuticals, Inc.
Aerie is a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class therapies for the treatment of patients with glaucoma and other diseases of the eye. Aerie’s two current product candidates are once-daily intraocular pressure lowering therapies with novel mechanisms of action to treat patients with glaucoma or ocular hypertension. The NDA (new drug application) for Rhopressa™ (netarsudil ophthalmic solution) 0.02% was submitted to the U.S. Food and Drug Administration (FDA) in February 2017, and, in May 2017, the FDA set the PDUFA (Prescription Drug User Fee Act) goal date for the completion of the FDA’s review™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, which is a fixed dose combination of Rhopressa™ and widely prescribed PGA latanoprost, achieved its primary efficacy endpoint in two Phase 3 registration trials, named Mercury 1 and Mercury 2, and also achieved successful 12-month safety and efficacy results in Mercury 1. The Roclatan™ NDA submission is expected to take place in the first half of 2018. Aerie is also focused on the development of additional product candidates and technologies in ophthalmology.
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