NicOx Newswire

NicOx Newswire

Comprehensive Real-Time News Feed for NicOx.

Results 1 - 20 of 49 in NicOx

  1. Nicox: Issuing and admission to trading on the Euronext regulated...Read the original story

    Thursday Jun 8 | World News Report

    Nicox announces the issuing and admission to trading on the Euronext regulated market in Paris of 597,897 new shares awarded to existing Aciex shareholders following the US FDA's approval of the new drug application in the US for ZERVIATE 0.24%. Nicox S.A. , the international ophthalmic R&D company, has announced a capital increase of a nominal amount of €597,897 by means of the issuing and admission to trading on the Euronext regulated market in Paris of 597,897 new shares following the approval by the US FDA of the new drug application in the US for ZERVIATE 0.24% , in order to provide existing Aciex shareholders with the Nicox shares due to them in respect of their category A-1 stock warrants .

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  2. Nicox Receives FDA Approval of Zerviate (cetirizine ophthalmic solution) 0.24%Read the original story w/Photo

    Wednesday May 31 | Drugs.com

    Nicox S.A. , the international ophthalmic R&D company, today announced that the U.S. Food and Drug Administration has approved the New Drug Application for Zerviate1 the first topical ocular formulation of this well-known antihistamine, for the treatment of ocular itching associated with allergic conjunctivitis. "Receiving approval from the U.S. FDA for Zerviate is a huge milestone for Nicox and partnering discussions are underway for U.S. commercialization rights," commented Michele Garufi, Chairman and Chief Executive Officer of Nicox.

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  3. FDA Approves Nicoxa s Zerviate, the First Topical Ocular Formulation of Antihistamine CetirizineRead the original story w/Photo

    Sunday Jun 4 | Vision Monday

    SOPHIA ANTIPOLIS, France- Nicox S.A. , an ophthalmic research and discovery company, has announced that the Food and Drug Administration has approved its new drug Zerviate , the first topical ocular formulation of this antihistamine. The new drug is approved as a treatment for ocular itching associated with allergic conjunctivitis.

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  4. Ms. Lauren P. Silvernail Appointed To NicOx SA Board Of DirectorsRead the original story

    May 16, 2017 | BioSpace

    May 17, 2017 - release at 7:30 am CET Sophia Antipolis, France Nicox S.A. , the international ophthalmic R&D company, today announced the appointment of Ms. Lauren P. Silvernail to the Company's Board of Directors, for a period of four years.

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  5. Dutch Biotech Firm Argenx SE Set To Dual ListRead the original story w/Photo

    May 17, 2017 | Seeking Alpha

    ... management experience, including 19 years in the biopharmaceutical industry. Previously, he served as the CFO of Nicox SA (1998 to 2014). Castaldi holds an undergraduate degree in finance, accountancy and administration from the University of Nice. ...

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  6. Ms. Lauren P. Silvernail appointed to Nicox Board of DirectorsRead the original story

    May 16, 2017 | World News Report

    Ms. Lauren P. Silvernail appointed to Nicox Board of Directors   Renewal of the terms of office of Birgit Stattin Norinder and Michele Garufi   May 17, 2017 - release at 7:30 am CET Sophia Antipolis, France   Nicox S.A. , the international ophthalmic R&D company, today announced the appointment of Ms. Lauren P. Silvernail to the Company's Board of Directors, for a period of four years.

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  7. FMI Releases New Report on the Dry Eye Syndrome Treatment Market 2016-2026Read the original story w/Photo

    May 8, 2017 | PR-inside.com

    ... artificial tear REFRESH OPTIVE gel drops to provide artificial tear option to relieve dry eye symptoms. In 2014, Nicox S.A. a French pharmaceutical company launched AdenoPlus and Xailin to relief of dry eye symptoms. Globally, increasing patient ...

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  8. NicOx SA First Quarter 2017 Business Update And Cash PositionRead the original story

    Apr 26, 2017 | BioSpace

    Nicox first quarter 2017 business update and cash position VyzultaTM1 PDUFA date set for August 24, 2017 ZERVIATE2 PDUFA date set for September 8, 2017 NCX 4251 and NCX 470 on track to enter Phase 2 Cash position of 25 million3 as of March 31, 2017 April 27, 2017 Sophia Antipolis, France Nicox S.A. , the international ophthalmic R&D company, today provided an update on its activities and cash position as of March 31, 2017.

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  9. Nicox Announces PDUFA Date for Zerviate NDARead the original story w/Photo

    Apr 10, 2017 | Drugs.com

    Nicox S.A. , the international ophthalmic R&D company, today announced that the U.S. Food and Drug Administration has set a PDUFA date of September 8, 2017 for its decision on the New Drug Application for Zerviate1 0.24%, Nicox's novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis. Michele Garufi, Chairman and Chief Executive Officer of Nicox, commented: "The FDA's acknowledgement regarding the completeness of the NDA resubmission for Zerviate and the assignment of a PDUFA goal date of September 8, 2017 are important milestones for Nicox.

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  10. NicOx Sa Announces Pdufa Date For Zerviate NdaRead the original story

    Apr 10, 2017 | BioSpace

    Nicox S.A. , the international ophthalmic R&D company, today announced that the U.S. Food and Drug Administration has set a PDUFA date of September 8, 2017 for its decision on the New Drug Application for ZERVIATE1 0.24%, Nicox's novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis. Michele Garufi, Chairman and Chief Executive Officer of Nicox, commented : "The FDA's acknowledgement regarding the completeness of the NDA resubmission for ZERVIATE and the assignment of a PDUFA goal date of September 8, 2017 are important milestones for Nicox.

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  11. Nicox announces Pdufa date for Zerviate NdaRead the original story

    Apr 10, 2017 | World News Report

    April 11, 2017 Sophia Antipolis, France Nicox S.A. , the international ophthalmic R&D company, today announced that the U.S. Food and Drug Administration has set a PDUFA date of September 8, 2017 for its decision on the New Drug Application for ZERVIATE 0.24%, Nicox's novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis.

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  12. NicOx SA: Business Update And 2016 Financial ResultsRead the original story

    Mar 30, 2017 | BioSpace

    Two potential U.S. product approvals for Vyzulta 1 0.024% and ZERVIATE2 0.24% expected in 2017 Strong pipeline including two products poised to enter in Phase 2 clinical trials Significant reduction in future fixed costs Cash position of a 28.9 million as of December 31, 2016 March 31, 2017 - Sophia Antipolis, France - Nicox S.A. , the international ophthalmic R&D company, today announced its financial and operating results for the year ended December 31, 2016, as approved by the Board of Directors on March 29, 2017, and provided an overview of its milestones and activities.

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  13. Bausch + Lomb And Nicox Announce PDUFA Date For Novel Glaucoma Candidate Latanoprostene BunodRead the original story w/Photo

    Mar 20, 2017 | Drugs.com

    Valeant Pharmaceuticals International, Inc.'s wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. today announced that the U.S. Food and Drug Administration has set a PDUFA date of August 24, 2017 for its decision on the New Drug Application for latanoprostene bunod ophthalmic solution, 0.024%. Latanoprostene bunod is an intraocular pressure lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma or ocular hypertension .

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  14. Bausch & Lomb And NicOx SA Announce PDUFA Date For Novel Glaucoma Candidate Latanoprostene BunodRead the original story

    Mar 20, 2017 | BioSpace

    ... -- Valeant Pharmaceuticals International, Inc.'s (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. (Euronext Paris: FR0013018124, COX) today announced that the U.S. Food and Drug Administration (FDA) has set a PDUFA ...

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  15. Nicox Resubmits AC-170 (Zerviate) NDA to the U.S. FDARead the original story w/Photo

    Mar 8, 2017 | Drugs.com

    March 9, 2017 -- Nicox S.A. , the international ophthalmic R&D company, today announced the resubmission of the New Drug Application for AC-170, its novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis. The brand name provisionally approved by the U.S. Food and Drug Administration for AC-170 is Zerviate1.

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  16. Nicox resubmits AC-170 NDA after API supplier resolves GMP issuesRead the original story w/Photo

    Mar 9, 2017 | In-PharmaTechnologist.com

    Nicox S.A. has resubmitted AC-170, its conjunctivitis associated itching drug candidate, for US FDA review after its API supplier resolved the problems that saw the agency reject the New Drug Application last year. The French drug firm announced the resubmission today, explaining that it is seeking approval for AC-170 - which has the provisional brand name Zerviate cetirizine ophthalmic solution - as a treatment for ocular itching associated with allergic conjunctivitis.

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  17. NicOx SA Resubmits AC-170 (ZERVIATE) NDA To The FDARead the original story

    Mar 8, 2017 | BioSpace

    CGMP issues at the API manufacturer have been resolved NDA resubmitted on March 8, 2017 ZERVIATE as the brand name provisionally approved by the U.S. FDA for AC-170 Nicox S.A. , the international ophthalmic R&D company, today announced the resubmission of the New Drug Application for AC-170, its novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis. The brand name provisionally approved by the U.S. Food and Drug Administration for AC-170 is ZERVIATE.

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  18. Nicox resubmits AC-170 (ZERVIATE) NDA to the U.S. FDARead the original story

    Mar 8, 2017 | World News Report

    Nicox resubmits AC-170 NDA to the U.S. FDA   CGMP issues at the API manufacturer have been resolved NDA resubmitted on March 8, 2017 ZERVIATE as the brand name provisionally approved by the U.S. FDA for AC-170   March 9, 2017 Sophia Antipolis, France   Nicox S.A. , the international ophthalmic R&D company, today announced the resubmission of the New Drug Application for AC-170, its novel, proprietary, cetirizine eye drop formulation for the treatment of ocular itching associated with allergic conjunctivitis.  The brand name provisionally approved by the U.S. Food and Drug Administration for AC-170 is ZERVIATE.

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  19. Bausch + Lomb And Nicox Resubmit US New Drug Application For Novel...Read the original story w/Photo

    Feb 26, 2017 | Drugs.com

    Valeant Pharmaceuticals International, Inc.'s wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. today announced the resubmission of a New Drug Application to the U.S. Food and Drug Administration seeking approval for latanoprostene bunod ophthalmic solution, 0.024%. Latanoprostene bunod is an intraocular pressure lowering single-agent eye drop dosed once daily, for patients with open angle glaucoma or ocular hypertension .

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  20. Nicox to participate at two upcoming investor conferencesRead the original story

    Mar 1, 2017 | World News Report

    Nicox to participate at two upcoming investor conferences   March 1, 2017 Sophia Antipolis, France Nicox S.A. , the international ophthalmic R&D company, today announced that members of the management team will participate in the following investor conferences in March 2017 in the United States: Cowen and Company 37th Annual Health Care Conference on Tuesday, March 7 at 9:20 a.m. ET at the Boston Marriott Copley Place in Boston.  The presentation will be available on Nicox website in "Presentations & Events".  Oppenheimer 27th Annual Healthcare Conference on Wednesday, March 22 at 8:35 a.m. ET at the Westin Grand Central Hotel in New York.

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