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Nicox SA (NCOX.PA)

NCOX.PA on Paris Stock Exchange

9.30EUR
22 Mar 2017
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Latest Key Developments (Source: Significant Developments)

Bausch + Lomb and Nicox announce PDUFA date for novel glaucoma candidate latanoprostene bunod
Monday, 20 Mar 2017 05:00pm EDT 

Nicox Sa : Bausch + lomb and nicox announce pdufa date for novel glaucoma candidate latanoprostene bunod .Valeant - fda has set a pdufa date of august 24, 2017 for its decision on new drug application (nda) for latanoprostene bunod ophthalmic solution.  Full Article

Nicox resubmits AC-170 (ZERVIATE) NDA to the U.S. FDA
Thursday, 9 Mar 2017 01:44am EST 

Nicox SA :Reg-Nicox resubmits AC-170 (ZERVIATE) NDA to the U.S. FDA.  Full Article

Bausch + Lomb, Nicox resubmit US NDA for Latanoprostene Bunod
Monday, 27 Feb 2017 01:30am EST 

Nicox Sa : Bausch + Lomb and Nicox resubmit US New Drug Application for novel glaucoma candidate Latanoprostene Bunod .Data submitted in NDA support Latanoprostene Bunod as first nitric-oxide donating prostaglandin f2α analog for ophthalmic use.  Full Article

Nicox receives complete response letter from FDA for AC-170
Monday, 10 Oct 2016 01:31am EDT 

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 02:30am EDT 

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 02:30am EDT 

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 01:30am EDT 

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 01:30am EDT 

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 01:30am EDT 

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

NicOx submits new drug application for AC-170 to U.S. FDA
Monday, 18 Apr 2016 08:00pm EDT 

NicOx SA:Submits new drug application for AC-170 to U.S. FDA.Approval of the AC-170 NDA prior to 1st December 2016 will trigger a milestone payment of $35 million in Nicox shares to ex-Aciex shareholders or $10 million in Nicox shares if approval of the NDA is received after this date.Also commenced an additional clinical safety study on AC-170.  Full Article

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BRIEF-Bausch + Lomb and Nicox announce PDUFA date for novel glaucoma candidate latanoprostene bunod

* Bausch + lomb and nicox announce pdufa date for novel glaucoma candidate latanoprostene bunod