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EYEG

EyeGate

$0.47

0.0799 (20.48%)

08:42
04/09/18
04/09
08:42
04/09/18
08:42

EyeGate receives FDA Fast Track designation for EyeGate OBG

EyeGate Pharmaceuticals announced that it has received a letter from the FDA responding to the company's amended investigational device exemption, or IDE, application for a second pilot study of the company's lead product, EyeGate Ocular Bandage Gel, or EyeGate OBG, a cross-linked thiolated carboxymethyl hyaluronic acid, or CMHA-S, platform being developed for the acceleration of re-epithelialization of large corneal epithelial defects in patients having undergone photorefractive keratectomy, or PRK. In its letter, the FDA identified four deficiencies in the Company's submission, requesting additional information on the manufacturing processes associated with the EyeGate OBG product. The primary comment relates to the validation of the filter specifically used for sterilization of the CMHA material, while the remaining comments include a request for clarification to the previously submitted data and modifications to the manufacturing process documents.

EYEG EyeGate
$0.47

0.0799 (20.48%)

02/06/18
HCWC
02/06/18
NO CHANGE
Target $3
HCWC
Buy
EyeGate price target lowered to $3 from $5 at H.C. Wainwright
H.C. Wainwright analyst Raghuram Selvaraju lowered his price target for EyeGate Pharmaceuticals to $3 after the top-line results from the Phase 2b trial of the iontophoretically-delivered EGP-437 combination product for the treatment of pain and inflammation after cataract surgery did not show statistical significance in the co-primary endpoints. However, EGP-437 showed numerically better clinical efficacy throughout the study, especially from day 14 to day 28, Selvaraju tells investors in a research note. He reiterates a Buy rating on EyeGate.
06/14/17
RODM
06/14/17
NO CHANGE
Target $6
RODM
Buy
EyeGate price target lowered to $6 from $10 at Rodman & Renshaw
Rodman & Renshaw analyst Raghuram Selvaraju lowered his price target for EyeGate Pharmaceuticals (EYEG( to $6 after the company granted a subsidiary of Valeant Pharmaceuticals (VRX) exclusive commercial and manufacturing rights to the EyeGate II Delivery System and EGP-437 combination product for treatment of post-operative pain and inflammation in ocular surgery patients. The analyst views the development, along with the top-line data from the first-in-human pilot trial of ocular bandage gel in patients with large corneal epithelial defects, as positive developments and raised his valuation of the company to $112M from $80M. His lowered target reflects higher shares outstanding. Selvaraju reiterates an Outperform rating on EyeGate.

TODAY'S FREE FLY STORIES

KEG

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LOW

Lowe's

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STXB

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STKS

One Group Hospitality

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LOW

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CDNS

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KW

Kennedy Wilson

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LOW

Lowe's

$91.34

-1.95 (-2.09%)

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Earnings
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SNPS

Synopsys

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CYAD

Celyad

$26.97

(0.00%)

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CSII

Cardiovascular Systems

$28.79

-1.7 (-5.58%)

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  • 20

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ACAD

Acadia

$18.14

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, KKR

KKR

$21.08

-0.75 (-3.44%)

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ACAD

Acadia

$18.14

-0.78 (-4.12%)

KKR

KKR

$21.08

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MDGL

Madrigal Pharmaceuticals

$120.49

-8.98 (-6.94%)

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  • 20

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MCD

McDonald's

$186.69

-0.96 (-0.51%)

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KEX

Kirby

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EFX

Equifax

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0.84 (0.83%)

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IOVA

Iovance Biotherapeutics

$8.90

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  • 20

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FLWS

1-800-Flowers.com

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BSX

Boston Scientific

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DHR

Danaher

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ARRS

Arris

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COO

Cooper Companies

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AMP

Ameriprise

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EPAM

Epam Systems

$120.96

-4.25 (-3.39%)

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