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AERI

Aerie Pharmaceuticals

$52.40

1.5 (2.95%)

06:32
05/15/18
05/15
06:32
05/15/18
06:32

Aerie Pharmaceuticals submits NDA to FDA for Roclatan

Aerie Pharmaceuticals announced the submission of its New Drug Application to the U.S. FDA for Roclatan 0.02%/0.005%. Roclatan is a once-daily eye drop designed to reduce intraocular pressure in patients with glaucoma or ocular hypertension. It is a fixed dose combination of Aerie's Rhopressa, which is currently available in the United States, and the widely-prescribed PGA latanoprost. Roclatan successfully 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 results of which are included in the NDA submission. The expected FDA review period for Roclatan NDA is only ten months instead of twelve months because Aerie's submission is filed under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act, since Roclatan is a fixed dose combination of two previously approved drugs in the United States.

  • 16

    May

AERI Aerie Pharmaceuticals
$52.40

1.5 (2.95%)

01/26/18
GHSC
01/26/18
INITIATION
Target $78
GHSC
Buy
Aerie Pharmaceuticals initiated with a Buy at Seaport Global
Seaport Global analyst Corey Davis initiated Aerie Pharmaceuticals with a Buy and $78 price target. The analyst expects a successful Q2 launch for Rhopressa in glaucoma, a market that has not seen a new chemical entity in more than 20 years. Davis believes this novel mechanism that targets the site of disease pathology to drive usage in combination therapy for those patients that are not reaching goal with their current glaucoma treatments. This corrects a prior note regarding the reasons for the analyst's rating.
02/16/18
HCWC
02/16/18
INITIATION
Target $78
HCWC
Buy
Aerie Pharmaceuticals assumed with a Buy at H.C. Wainwright
H.C. Wainwright analyst Oren Livnat assumed coverage of Aerie Pharmaceuticals with a Buy rating and $78 price target.
03/01/18
CANT
03/01/18
NO CHANGE
Target $86
CANT
Overweight
Aerie Pharmaceuticals price target raised to $86 from $77 at Cantor Fitzgerald
Cantor Fitzgerald analyst Elemer Piros raised his price target for Aerie Pharmaceuticals to $86 to reflect the decrease in the future tax rate to 21% from 35%. The analyst reiterates an Overweight rating on the shares following the company's Q4 results.
05/01/18
MZHO
05/01/18
NO CHANGE
Target $77
MZHO
Buy
Aerie Pharmaceuticals price target lowered to $77 from $87 at Mizuho
Mizuho analyst Difei Yang lowered her price target for Aerie Pharmaceuticals to $77 citing a reduction in takeover premium in her valuation. The analyst does not expect a takeover to occur during the Rhopressa launch phase. Yang keeps a Buy rating on Aerie and continues to have confidence that management can successfully execute the launch.

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