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PSDV

pSivida

$2.94

-0.07 (-2.33%)

07:09
10/04/16
10/04
07:09
10/04/16
07:09

pSivida Phase 3 trial of Medidur meets enrollment target

pSivida announced that its second Phase 3 trial of Medidur in chronic, non-infectious posterior segment uveitis met its target enrollment of 150 patients. The trial is being conducted in clinical sites in India, with the same study design and endpoints as the first Phase 3 trial conducted in the U.S., EU and India. The results of both Phase 3 trials will support U.S. product registration, with NDA submission planned for the second half of 2017. Filing for EU registration remains on track for Q1 of 2017. This first Medidur trial met the primary efficacy endpoint of prevention of recurrence of posterior segment uveitis at six months in December 2015. Primary efficacy endpoint readout in the second study is expected in the second half of 2017.

PSDV pSivida
$2.94

-0.07 (-2.33%)

12/17/15
NORL
12/17/15
NO CHANGE
Target $10
NORL
Outperform
Alimera sale would have implications for pSivida, says Northland
Northland analyst Suraj Kalia noted the Reuters report that Alimera Sciences (ALIM), a licensee of pSivida (PSDV), is exploring strategic alternatives. If Alimera get bought, the acquirer could keep its current contractual arrangement with pSivida, under which it is entitled to 20% of "net profits" on sales of Iluvien in DME, in place, or could try to negotiate an upfront lump sum payment to pSivida for Iluvien, the analyst stated. Kalia keeps an Outperform rating and $10 price target on pSivida shares.
12/22/15
NORL
12/22/15
NO CHANGE
Target $10
NORL
Outperform
pSivida' Meddidur results a big positive, says Northland
Northland analyst Suraj Kalia said pSivida announced strong Phase III results from its Medidur uveitis study. Overall, the data improves pSivida's bargaining position if a strategic buyer steps in for partner Alimera, and it positions pSivida strongly from a go-direct strategy perspective, the analyst reported. Kalia rates pSivida an Outperform with a $10 price target on shares.
12/23/15
LTCO
12/23/15
NO CHANGE
Target $12.5
LTCO
Buy
pSivida price target raised to $12.50 from $8 at Ladenburg
Ladenburg analyst Matthew Kaplan raised pSivida's price target to $12.50 from $8 and reiterated his Buy rating following the "outstanding" top-line data for first Medidur Phase 3 trial in treating chronic noninfectious posterior uveitis. Kaplan said the data presents a strong case that the FDA may allow Medidur NDA filing without completion of the 2nd Phase 3 study.
06/23/16
FBRC
06/23/16
NO CHANGE
FBRC
Outperform
pSivida could see positive catalysts shortly, says FBR Capital
FBR Capital analyst Vernon Bernardino thinks pSivida is on track to announce the 12-month data from the first Medidur Phase III trial, which he expects to be a significant catalyst, in July and that an IND filing for a Durasert osteoarthritis product by the company's partner is on track to be announced in the next few weeks. Given the company's upcoming catalysts, its potential to turn positive on cash flow in the near-term and its attractive potential as an acquisition target, the firm reiterates its Outperform rating on pSivida.

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