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AERI

Aerie Pharmaceuticals

$51.65

-4.45 (-7.93%)

16:06
08/08/17
08/08
16:06
08/08/17
16:06

Aerie Pharmaceuticals comments on status of contract manufacturer for Rhopressa

Aerie Pharmaceuticals has received notification by its contract drug product manufacturer that the contract manufacturer has received a Complete Response Letter from the FDA, regarding the contract manufacturer's New Drug Application for one of their own product candidates, and which refers to a Current Good Manufacturing Practice inspection at the facility. The contract manufacturer will work with the FDA to determine the appropriate next steps. This facility also manufactures on a contract basis Aerie's product candidate Rhopressa, which has a Prescription Drug User Fee Act goal date of February 28, 2018. Aerie currently believes it is probable that open issues will be resolved prior to the February 28, 2018 PDUFA date for Rhopressa.

  • 09

    Aug

  • 28

    Feb

AERI Aerie Pharmaceuticals
$51.65

-4.45 (-7.93%)

04/13/17
HCWC
04/13/17
NO CHANGE
Target $42
HCWC
Buy
Aerie pullback on hyperemia increase an overreaction, says H.C. Wainwright
H.C. Wainwright analyst Corey Davis said despite the "positive" safety and efficacy data Aerie Pharmaceuticals' reported from its trial of Rhopressa, "focus for the Street" was clearly on the 48% hyperemia rate and 31% discontinuation rate. However, the rate of events outside of hyperemia is relatively comparable to that seen with approved products Lumigan and Travatan and mild redness is likely of little real-world concern in a condition as serious as glaucoma, he tells investors. The analyst, who sees the first-read response in the shares as an overreaction, has a Buy rating and $69 price target on Aerie shares, which are down about 1% to $42 in pre-market trading after suffering a sharper decline in after-market trading last night.
05/25/17
COWN
05/25/17
NO CHANGE
Target $100
COWN
Outperform
Aerie Pharmaceuticals probability of a takeout increasing, says Cowen
Cowen analyst Tyler Van Buren noted the Aerie Pharmaceuticals Roclatan trial was successful and appears approvable as the first FDA approved prostaglandin product. He also noted its Rhopressa drug which is also under review appears approvable as well and combined, the drugs represent a $1.5B long duration opportunity. The analyst believes Aerie is a prime consolidation candidate and said it is not unreasonable to put a 4x multiple on peak sales of $1.5B arrives at a $130-$140 per shares valuation. Van Buren reiterated his Outperform rating and raised his price target to $100 from $70 on Aerie Pharmaceuticals shares.
05/25/17
NEED
05/25/17
NO CHANGE
Target $65
NEED
Buy
Aerie Pharmaceuticals price target raised to $65 from $58 at Needham
Needham analyst Serge Belanger raised his price target for Aerie Pharmaceuticals to $65 saying the company reported positive results from Mercury-2, the second of two Phase 3 trials evaluating Roclatan as treatment for glaucoma. Once again, Roclatan met all its endpoints, Belanger tells investors in a research note. The data are a "key derisking event" for the program, the analyst adds. He keeps a Buy rating on Aerie.
07/03/17
ADAM
07/03/17
NO CHANGE
Target $65
ADAM
Buy
Aerie price target raised to $65 from $60 at Canaccord
Canaccord analyst Dewey Steadman said he remains confident in Aerie Pharmaceuticals' ability to launch Rhopressa as early at the first half of next year, noting that the company is preparing for an FDA advisory committee meeting that could happen before Thanksgiving. Steadman, who sees Rhopressa as a $500M product at its peak, also said he's confident in a potential Roclatan approval in 2019, stating that could be a $1B product. The analyst keeps a Buy rating on Aerie shares and raised his price target on the stock to $65 from $60.

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