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AERI

Aerie Pharmaceuticals

$62.95

-1.35 (-2.10%)

07:06
10/13/17
10/13
07:06
10/13/17
07:06

Aerie Pharmaceuticals stock trading halted ahead of FDA committee meeting

Aerie Pharmaceuticals announced that NASDAQ has halted trading of the company's common stock. A meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee of the U.S. FDA has been scheduled for today to review the Company's New Drug Application for Rhopressa 0.02% for the treatment of patients with open-angle glaucoma or ocular hypertension. Aerie submitted the NDA for Rhopressa to the FDA in February 2017, following which the FDA set a PDUFA goal date of February 28, 2018 for the completion of its review of the Rhopressa NDA. The Advisory Committee meeting is scheduled to begin at 8:30 a.m. ET.

  • 13

    Oct

  • 28

    Feb

AERI Aerie Pharmaceuticals
$62.95

-1.35 (-2.10%)

10/11/17
JMPS
10/11/17
NO CHANGE
Target $68
JMPS
Outperform
Rhopressa meeting briefing document 'bullish' for Aerie, says JMP Securities
JMP Securities analyst Donald Ellis called the briefing document for the advisory meeting to review Aerie Pharmaceuticals' Rhopressa "bullish," noting that the document included a statement that the company has shown in three Phase 3 trials that the drug is non-inferior to timolol. "Surprisingly," the FDA included a sample product label, which it rarely does, suggesting the agency "is fully planning on approving Rhopressa," Ellis tells investors. He maintains an Outperform rating and $68 price target on Aerie shares, which are up 16% to $64.20 in afternoon trading.
10/11/17
MZHO
10/11/17
NO CHANGE
MZHO
Buy
FDA stance looks favorable towards Aerie's Rhopressa, says Mizuho
Mizuho analyst Difei Yang said the briefing documents for the FDA's advisory committee meeting to discuss Rhopressa make it appear that the agency's stance is favorable towards Aerie's treatment. The analyst views the FDA's modifications to Aerie's proposed language to be "very minor" and is encouraged by the language used in the indication and usage section. Yang keeps a Buy rating on Aerie Pharmaceuticals shares, which are trading higher following the posting of the meeting documents.
10/05/17
COWN
10/05/17
NO CHANGE
Target $100
COWN
Outperform
Aerie Pharmaceuticals should receive positive FDA review next week, says Cowen
Cowen analyst Tyler Van Buren conducted an ophthalmology panel and survey and received very optimistic responses suggesting Rhopressa should receive a positive advisory committee vote on October 13, which should ultimately lead to approval. The panelists he spoke to believed the company's Rocket clinical trial program demonstrated that Rhopressa is an effective agent as it achieved non-inferiority to timolol, said Van Buren, who reiterated his Outperform rating and $100 price target on Aerie Pharmaceuticals shares.
10/02/17
MZHO
10/02/17
NO CHANGE
Target $70
MZHO
Buy
Aerie recent weakness a buying opportunity, says Mizuho
Mizuho analyst Difei Yang noted that Aerie Pharmaceuticals shares have fallen by about 20% since the company announced on September 20 that the FDA will hold an advisory committee meeting to discuss Rhopressa. However, after speaking with Aerie's management, the analyst believes a fair amount of preparation had already taken place prior to receiving the FDA notice and views the pullback in the stock as a buying opportunity. Yang keeps a $70 price target and Buy rating on Aerie shares.

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DVN

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DVN

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