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Nicox SA (NCOX.PA)

NCOX.PA on Paris Stock Exchange

9.85EUR
15 Dec 2017
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Latest Key Developments (Source: Significant Developments)

Bausch + Lomb and Nicox announces FDA approval of Vyzulta
Friday, 3 Nov 2017 

Nov 2 (Reuters) - Valeant Pharmaceuticals International Inc :Bausch + Lomb and Nicox announce FDA approval of Vyzulta™ (latanoprostene Bunod Ophthalmic Solution), 0.024%.Valeant - ‍co's wholly owned subsidiary, Bausch + Lomb and Nicox S.A announced FDA approved NDA for Vyzulta​.  Full Article

Nicox says ‍cash balance was 47.1 million euros as of Sept. 30
Tuesday, 24 Oct 2017 

Oct 24 (Reuters) - NICOX SA ::‍CASH BALANCE OF EUR 47.1 MILLION AS OF SEPTEMBER 30, 2017​.Q3 NO REVENUE ‍​ VERSUS NO REVENUE YEAR AGO.  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

Nicox receives complete response letter from FDA for AC-170
Monday, 10 Oct 2016 

Nicox SA : Receives complete response letter from FDA related to GMP on NDA for AC-170 . FDA's stated reason for CRL pertains to good manufacturing practice inspection at a third party facility producing API cetirizine and supplying it to manufacturer of finished product .Safety and efficacy data submitted by Nicox in AC-170 NDA have not resulted in FDA requesting any further clinical or non-clinical testing for approval.  Full Article

Nicox raises 18 mln euros to finance R&D
Thursday, 28 Jul 2016 

Nicox SA : Nicoxraises 18 million euros ($20.0 million) to finance development of its pipeline .Proceeds to finance development of NCX 4251 in blepharitis and NCX 470 in glaucoma and for general corporate purposes.  Full Article

FDA to inspect Nicox partner Bausch + Lomb
Friday, 22 Jul 2016 

Nicox SA : Has been informed by its partner Bausch + Lomb, a Valeant unit , of receipt of a complete response letter from U.S. FDA concerning latanoprostene bunod . FDA's letter did not identify any efficacy or safety concerns with respect to NDA or additional clinical trials needed for approval of NDA for latanoprostene bunod ophthalmic solution, 0.024 pct . Concerns raised by the FDA pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb's manufacturing facility in Tampa, Florida . Some deficiencies were identified by the FDA at the Tampa plant .Valeant intends to meet with FDA as soon as possible to work on a resolution and address these concerns.  Full Article

Nicox to transfer commercial operations to new company, gets minority stake
Tuesday, 5 Jul 2016 

Nicox SA : Nicox to transfer commercial operations to new pan-European ophthalmic specialty pharmaceutical company led by GHO Capital . Transaction values Nicox's European and international commercial operations and related late-stage development programs at up to 26 million euros ($28.9 million) .Nicox to receive a 9 million euro upfront cash payment and a minority stake in new company.  Full Article

FDA grants priority review for Nicox's AC-170 new drug application
Tuesday, 21 Jun 2016 

Nicox SA : FDA grants priority review for Nicox's AC-170 new drug application .FDA also granted priority review and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 18, 2016.  Full Article

Nicox Q1 revenue rises to 3.5 million euros
Tuesday, 10 May 2016 

Nicox SA : Q1 revenue EUR 3.5 million ($3.98 million) versus EUR 2.1 million year ago . Cash burn in Q1 2016 included EUR 3.1 million of non-recurrent spending .Cash, cash equivalents and financial instruments EUR 20.8 million as of March 31.  Full Article

BRIEF-Bausch + Lomb and Nicox announces FDA approval of Vyzulta

* Bausch + Lomb and Nicox announce FDA approval of Vyzulta™ (latanoprostene Bunod Ophthalmic Solution), 0.024%