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pSivida Corp (PSDV.OQ)

PSDV.OQ on NASDAQ Stock Exchange Global Market

1.10USD
16 Jan 2018
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Latest Key Developments (Source: Significant Developments)

pSivida Submits New Drug Application For Durasert Three-Year Treatment For Posterior Segment Uveitis To The U.S. FDA
Monday, 8 Jan 2018 

Jan 8 (Reuters) - pSivida Corp ::PSIVIDA SUBMITS NEW DRUG APPLICATION (NDA) FOR DURASERT™ THREE-YEAR TREATMENT FOR POSTERIOR SEGMENT UVEITIS TO THE U.S. FDA.PSIVIDA CORP - ‍SUBMITTED NDA TO U.S. FDA FOR DURASERT THREE-YEAR TREATMENT FOR POSTERIOR SEGMENT UVEITIS​.  Full Article

Psivida Granted Waiver By The FDA For New Drug Application Filing Fee
Thursday, 4 Jan 2018 

Jan 4 (Reuters) - Psivida Corp ::PSIVIDA GRANTED WAIVER BY THE FDA FOR NEW DRUG APPLICATION FILING FEE.PSIVIDA CORP - ON TRACK TO FILE DURASERT NDA IN EARLY JANUARY.PSIVIDA - FDA GRANTED BUSINESS WAIVER OF PDUFA FEE OF ABOUT $2.4 MILLION FOR NDA FOR CO'S DURASERT 3 YEAR MICROINSERT FOR POSTERIOR SEGMENT UVEITIS.  Full Article

pSivida reports Q1 loss per share of $0.15
Tuesday, 7 Nov 2017 

Nov 7 (Reuters) - pSivida Corp ::Q1 loss per share $0.15.Q1 revenue $385,000 versus $277,000.Q1 revenue view $640,000 -- Thomson Reuters I/B/E/S.Q1 earnings per share view $-0.15 -- Thomson Reuters I/B/E/S.  Full Article

Nicox and pSivida enter collaboration agreement to develop sustained release drug for glaucoma patients​
Tuesday, 10 Oct 2017 

Oct 10 (Reuters) - Nicox SA :Nicox-Co and pSivida enter strategic collaboration agreement to develop sustained release drug to lower intraocular pressure in patients with glaucoma​.Would make additional payments for any incremental development activities for each implant formulation product candidate.Expected payments from Nicox associated with agreement are not considered material to Nicox's financial statements at this time​.Says ‍pSivida will be responsible for initial development activities of ocular insert formulations, for which it will receive undisclosed sums​.  Full Article

Nicox and pSivida enter strategic collaboration agreement
Tuesday, 10 Oct 2017 

Oct 10 (Reuters) - NICOX SA ::REG-NICOX AND PSIVIDA ENTER STRATEGIC COLLABORATION AGREEMENT TO DEVELOP SUSTAINED RELEASE DRUG TO LOWER INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA.NEW INTELLECTUAL PROPERTY FROM THE COLLABORATION RELATING TO THE DRUG-DEVICE COMBINATION WILL BE JOINTLY OWNED‍​.PSIVIDA TO BE RESPONSIBLE FOR INITIAL DEVELOPMENT ACTIVITIES OF OCULAR INSERT FORMULATIONS, FOR WHICH IT WILL RECEIVE UNDISCLOSED SUMS BY NICOX‍​.  Full Article

pSivida says primary endpoint met in utilization study of new Medidur inserter with smaller diameter needle
Tuesday, 9 Aug 2016 

pSivida Corp : Psivida corp says primary endpoint met in psivida's utilization study of new medidur inserter with smaller diameter needle .Results of study will form part of planned u.s. Nda and application for eu marketing authorization for medidur for posterior uveitis.  Full Article

Psivida Corp says first Phase 3 trial of Medidur continued to meet primary endpoint
Wednesday, 27 Jul 2016 

Psivida Corp :First phase 3 trial of medidur for treatment of posterior uveitis continued to meet its primary endpoint.  Full Article

pSivida to consolidate all R&D in current U.S. facility
Friday, 15 Jul 2016 

pSivida Corp : pSivida Corp announces plan to consolidate all research and development in current U.S. facility . Expects site consolidation plan will reduce pre-tax operating expenses by about $900,000 annually, beginning in Q2 of fiscal year 2017 . Says pSivida estimates that it will record approximately $680,000 of charges associated with plan . Charges are expected to be recorded primarily in Q1 of fiscal 2017, ending September 30, 2016 . Says charges include approximately $550,000 estimated to be cash expenditures . Site consolidation expected to be substantially completed during that quarter, subject to local U.K. Labor requirements .Proposes to close research facility in Malvern, U.K. & locate all research, product development activities in CGMP facility in Watertown, MA.  Full Article

BRIEF-pSivida Submits New Drug Application For Durasert Three-Year Treatment For Posterior Segment Uveitis To The U.S. FDA

* PSIVIDA SUBMITS NEW DRUG APPLICATION (NDA) FOR DURASERT™ THREE-YEAR TREATMENT FOR POSTERIOR SEGMENT UVEITIS TO THE U.S. FDA