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PSDV

pSivida

$1.06

-0.04 (-3.64%)

16:12
02/07/18
02/07
16:12
02/07/18
16:12

pSivida Durasert study maintains positive efficacy, safety profile at 12 months

-- pSivida announced that results from the Company's second Phase 3 trial for Durasert three-year treatment for posterior segment uveitis confirmed a significant reduction in uveitis recurrence rate at 12 months. The study involved 153 patients with posterior segment uveitis and the primary endpoint was prevention of recurrence of posterior uveitis at six months with patients continuing to be followed for 36 months. "The continued positive efficacy and safety data for Durasert, now confirmed in two separate Phase 3 studies at both six and 12 months, is encouraging for patients that are suffering from posterior segment uveitis," commented by Glenn J. Jaffe, M.D., Chief, Division of Retinal Ophthalmology, Duke University, and a primary clinical investigator in the phase 3 program. "While today's standard of care treatment options are mainly directed at controlling flares, Durasert is designed to help prevent flares for up to three years with a single injection administered in an office setting." "As we await the US Food and Drug Administration's decision on acceptance of our New Drug Applicationsubmitted in January, we are solidifying our go-to-market plan," added Nancy Lurker, President and CEO of pSivida. "We continue to receive highly positive feedback from specialists regarding Durasert three year for posterior segment uveitis, which bolsters our team's confidence that there will be strong interest to treat patients dealing with this devastating disease, which is the third leading cause of blindness, pending a favorable regulatory review."

  • 07

    Feb

PSDV pSivida
$1.06

-0.04 (-3.64%)

05/30/17
RODM
05/30/17
INITIATION
Target $8
RODM
Buy
pSivida initiated with a Buy at Rodman & Renshaw
Rodman & Renshaw analyst Raghuram Selvaraju started pSivida with a Buy rating and $8 price target.
06/13/17
LTCO
06/13/17
NO CHANGE
Target $12.5
LTCO
Buy
pSivida data on Durasert provide basis for NDA filing, says Ladenburg
Ladenburg analyst Matthew Kaplan was "impressed" with the results from pSivida's second Phase 3 trial of Durasert, which he said strongly confirm the efficacy and safety seen in the earlier study and can serve as the basis for a U.S. NDA filing. The company currently plans an NDA filing by Q4 and plans to commercialize Durasert via a contract sales organization, noted Kaplan, who reiterates a Buy rating and $12.50 price target on the stock, which is down 32c, or 15%, to $1.76 in afternoon trading.
12/04/17
RILY
12/04/17
INITIATION
Target $5
RILY
Buy
pSivida resumed with a Buy at B. Riley FBR
B. Riley FBR resumed coverage of pSivida with a Buy rating and $5 price target.

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SIG

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T

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SHI

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ORCL

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WGO

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HAL

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I

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DAL

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