Mizuho Securities USA LLC has reiterated its ‘Buy’ rating and price target of $70 on shares of Aerie Pharmaceuticals, Inc.’s (NASDAQ: AERI) stock following review of the Rhopressa advisory committee briefing package. The analyst noted that, upon review, they believe the FDA’s stance is favorable toward Aerie’s Rhopressa. Per the briefing package, the FDA agrees with Aerie’s conclusion regarding the overall efficacy of Rhopressa with once-daily dosing for the reduction of elevated intraocular pressure. The analyst noted that the FDA didn’t uncover anything concerning regarding Aeri’s safety findings. However, the FDA did suggest modifications to the proposed language used on the label, which the Mizuho analyst noted as ‘minor’.
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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