2019

Nicox: Third Quarter 2019 Business Update and Financial Highlights

  • Positive topline results from Dolomites Phase 2 clinical trial of NCX 470 in glaucoma
  • VYZULTA prescriptions exceeded 3,000 per week for the first time1
  • Q3 2019 net revenue of €0.5 million

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today provided a Q3 2019 business update and financial highlights,

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Nicox Amends Bond Financing Agreement with Kreos and Draws Down Additional €4 Million

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that it has amended its bond financing agreement with Kreos Capital and drawn down an additional €4 million of debt under the bond financing. Nicox may now draw down a further €3 million or €8 million on December 31, 2019, subject to notice to Kreos by December 16,

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Top Line Results from Glaucoma Dolomites Phase 2 Trial Show Nicox’s NCX 470 Meets Primary Endpoint and Demonstrates Statistical Superiority vs Latanoprost

  • NCX 470 met the primary endpoint of non-inferiority and also demonstrated superiority to latanoprost, the U.S. market leader in prostaglandin analog prescriptions, in multiple pre-specified analyses
  • Intraocular pressure (IOP) lowering effect from baseline of NCX 470 was 7.6 to 9.8 mmHg
  • All doses of NCX 470 were well tolerated with no drug-related serious adverse events

Sophia Antipolis,

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Nicox Completes Enrolment of NCX 4251 Phase 2 Trial with Top-Line Results on Track for Q4 2019

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that it has completed enrolment in its multicenter, dose escalating, U.S. Phase 2 clinical trial evaluating the safety and tolerability of NCX 4251 in acute exacerbations of blepharitis. The primary objective of this clinical trial is to select the dose(s) of NCX 4251 to advance into the next stage of development which will be a larger Phase 2b clinical trial.

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Nicox: First Half 2019 Financial Results and Business Update

  • H1 2019 net revenue1 of €5.6 million and net loss2 of €0.8 million
  • Enrollment completed in NCX 470 Phase 2 DOLOMITES clinical trial in patients with glaucoma or ocular hypertension. Top-line results on track for early Q4 2019
  • Collaboration in the Chinese market further strengthened with ZERVIATE and NCX 4251 transactions with Ocumension Therapeutics
  • Top-line results of NCX 4251 Phase 2 clinical trial on track for Q4 2019

Sophia Antipolis,

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Nicox: Second Quarter 2019 Business Update and Financial Highlights

  • Enrollment completed in the NCX 470 Phase 2 clinical trial in patients with glaucoma and ocular hypertension with results expected in early Q4 of this year
  • Q2 2019 net revenue, including licensing payments, of €5.2 million

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today provided Q2 2019 operational highlights,

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Nicox Announces Completion of Enrollment in NCX 470 Phase 2 Clinical Study with Top-Line Results on Track for Early 4Q 2019

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that it has completed enrollment of patients in its multicenter, United States (U.S.) Phase 2 clinical study evaluating NCX 470, a novel second generation nitric oxide (NO)-donating bimatoprost analog, being tested in patients with open-angle glaucoma or ocular hypertension for its ability to lower intraocular pressure (IOP).

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Nicox Receives $3 Million Milestone Payment from Eyevance for ZERVIATE in the U.S.

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that it has received a $3 million milestone payment from partner Eyevance Pharmaceuticals, triggered by the completion of the regulatory and manufacturing activities under Nicox’s responsibility necessary for the final manufacturing milestone payment in preparation for the future launch of ZERVIATETM in the U.S.

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Nicox signs agreement for NCX 4251 in China with Ocumension Therapeutics for up to €12 million in milestones plus royalties

  • Upfront payment of €2 million and potential future milestones of €10 million
  • Tiered royalties from 5% to 10%
  • With 3 partnered programs Nicox & Ocumension have forged a strong partnership in China

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, and Ocumension Therapeutics today announced they have entered into an exclusive license agreement for the development and commercialization of Nicox’s product candidate,

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Nicox: 2019 Ordinary Shareholder Meeting postponed to June 19, 2019

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, informs its shareholders that the ordinary general meeting convened on first call on June 4, 2019, cannot be held as the quorum required by law will not be reached.
The shareholders are thus convened on second call for an ordinary general meeting on the same agenda on Wednesday June 19,

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Nicox Presents First Data on Promising New Class of Nitric Oxide (NO)-Donating Compounds for Glaucoma at the ARVO 2019 Annual Meeting

  • Nitric oxide (NO)-donating phosphodiesterase-5 (PDE5) inhibitors constitute new drug class for patients with glaucoma
  • Lead molecule substantially and sustainably lowers intraocular pressure (IOP) in non-human primate model of ocular hypertension
  • Potential for development as adjunctive therapy or in fixed-dose combinations with latanoprost or other prostaglandin analogs (PGAs) for lowering IOP in patients with glaucoma or ocular hypertension

Nicox SA (Euronext Paris: FR0013018124,

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Nicox to Present at Upcoming Pharmaceutical Industry and Financial Events

Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that it will be presenting at the following pharmaceutical industry and financial events in Q2 2019:

  • Michele Garufi, Chairman and CEO, will present at the 2019 Ophthalmology Innovation Summit (OIS) on May 2, 2019, prior to the 2019 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting.
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Nicox: 2019 Ordinary Shareholder Meeting

Nicox SA (Euronext Paris: FR0013018124, COX), international ophthalmology company, has convened an ordinary shareholder meeting on Tuesday June 4, 2019 at 2:00 pm CET in the offices of BuroClub – Drakkar 2 – Bâtiment D – 2405 route des Dolines – 06560 Valbonne Sophia Antipolis – France.
The documents mentioned in articles R.225-73-1 of the French Code de commerce,

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Nicox First Quarter 2019 Business Update and Financial Highlights

  • Total VYZULTA® prescriptions for the first quarter 2019 increased by 18% compared to the fourth quarter 2018 and by 360% compared to the first quarter 2018
  • NCX 470 Phase 2 clinical trial in glaucoma over 85% enrolled
  • NCX 4251 Phase 2 clinical trial initiated in blepharitis
  • ZERVIATE multiple licensing discussions ongoing ex-U.S.
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Venez rencontrer et échanger avec les dirigeants de Nicox jeudi 9 mai 2019

Dans le cadre des soirées évènements organisées par Biotech Agora, une réunion débat avec la société Nicox est organisée le jeudi 9 mai à 18h45 à l’hôtel Bedford 17, rue de l’Arcade, 75008 Paris, au cours de laquelle vous aurez l’opportunité d’échanger avec Mr Michele Garufi, Président Directeur Général de Nicox, qui présentera les actualités de la Société,

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Nicox Initiates Phase 2 Trial of NCX 4251 in Blepharitis

  • Trial to randomize 30 blepharitis patients in clinical sites across the U.S.
  • Top-line results expected in Q4 2019
  • Targets the estimated $500+ million U.S. blepharitis market

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the initiation of a Phase 2 clinical trial evaluating NCX 4251,

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Nicox Poster Presentation at AGS 2019 Annual Meeting Discloses Preclinical Data for NCX 4251, a Novel Blepharitis Therapy

  • NCX 4251 is a novel therapy in development for blepharitis, administered via a novel route of delivery directly to eyelid margin, where blepharitis originates
  • Preclinical data supports dose ranging in Phase 2 clinical study up to the highest tested dose

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company,

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Nicox signs agreement for ZERVIATE in China for up to €17 million in milestone payments plus royalties

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, and Ocumension Therapeutics today announced they have entered into an exclusive license agreement for the development and commercialization of Nicox’s product ZERVIATETM (cetirizine ophthalmic solution), 0.24% for the treatment of allergic conjunctivitis for a territory comprising mainland China, Hong Kong,

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Nicox Announces Presentations at Upcoming Scientific Conferences

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced a number of presentations of data at scientific conferences.
Details of the presentations (all times PST):
AGS 2019 Annual Meeting – March 14-17, 2019, San Francisco, U.S.
Poster title: Preclinical Evaluation of NCX 4251, A Novel Steroid Therapy For Blepharitis, Targeted Directly To The Eyelid Margin To Reduce The Potential For IOP Elevations
Type: Poster session
Date: March 15,

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Nicox to participate in upcoming investor conferences

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that members of the management team will participate in the following investor conferences in Europe and U.S. in the coming months:

  • Cowen 39th Annual Health Care Conference, March 11-13 in Boston, U.S.
  • Oppenheimer’s 29th Annual Healthcare Conference,
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Nicox Announces 2018 Financial Results and 2019 Milestones

Net revenue1 increased by 74% Loss before tax in 2018 reduced compared to 2017 Cash balance and 2019 loan financing provide strong foundation for rapid advancement of Nicox’s clinical-stage programs Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the financial and operating results for Nicox and its subsidiaries…

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Nicox to Present at the Glaucoma 360 New Horizons Forum

Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that Tomas Navratil, PhD, Executive Vice President, Head of Development, will present at the Glaucoma 360 New Horizons Forum hosted by the Glaucoma Research Foundation on February 1st, 2019 at 1:22 PM PST. Dr. Navratil will present in the session…

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Nicox Announces U.S. FDA Acceptance of Investigational New Drug Application for NCX 4251 Phase 2 Trial in Blepharitis

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Company’s Investigational New Drug (IND) application for NCX 4251, a novel patented ophthalmic suspension of fluticasone propionate nanocrystals, being developed as the first targeted topical treatment of the eyelid margin for patients with acute exacerbations of blepharitis.

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Nicox Establishes High-Profile Glaucoma Clinical Advisory Board

  • Key U.S. clinical investigators and opinion leaders to support and guide the development of Nicox’s innovative NO-donating therapeutics including NCX 470 currently in a U.S. Phase 2 clinical study

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the formation of Nicox Glaucoma Clinical Advisory Board,

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Nicox Fourth Quarter 2018 Business Update and Financial Highlights

  • Total VYZULTA® prescriptions for the fourth quarter 2018 up 47% compared to the third quarter 2018
  • Quarterly net revenue of €3.3 million
  • Net revenue for the year 2018 of €4.0 million

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today provided Q4 2018 operational highlights,

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Nicox Reaches 50% Enrollment Threshold in U.S. Phase 2 Study with NCX 470 Ahead of Schedule

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced it has reached the 50% patient enrollment threshold of its multicenter, United States (U.S.) Phase 2 clinical study evaluating NCX 470 ahead of schedule. Nicox’s lead product candidate, NCX 470, is a novel, second-generation nitric oxide (NO)-donating prostaglandin analog for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

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VYZULTA Approved in Canada by Nicox’s Partner

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that its partner has received approval in Canada of VYZULTATM (latanoprostene bunod ophthalmic solution), 0.024%. Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Bausch Health Companies Inc. (NYSE/TSX: BHC) and exclusive global licensee for VYZULTATM,

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2018

Nicox Focuses Research Activities on Novel NO-Donating PDE5 Inhibitors for Glaucoma and Enters into Collaboration with Novaliq on Innovative Topical Ophthalmic Formulations

  • Encouraging preclinical efficacy data on NO-donating PDE5 inhibitors
  • Focusing of research activities on the most promising new pharmacologic classes
  • Collaboration with Novaliq to access novel formulation technology for these new compounds

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that it will be focusing its research activities on topical nitric oxide (NO)-donating phosphodiesterase-5 (PDE5) inhibitors and soluble guanylate cyclase (sGC) stimulators.

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Nicox and Ocumension Therapeutics Sign Exclusive License Agreement to Develop and Commercialize NCX 470 in the Chinese market

  • Accesses the fast-growing Chinese glaucoma market
  • Nicox to potentially receive up to €36.25 million in development and commercial milestones payments, including a €3 million upfront payment
  • Tiered royalties from 6% to 12% on net sales of NCX 470 in the Chinese market
  • Ocumension responsible for all development and commercialization activities in the Chinese market

Sophia Antipolis,

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Nicox to present at the 30th Annual Piper Jaffray Healthcare conference

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that Michele Garufi, Chairman and Chief Executive Officer of Nicox, will present at the 30th Annual Piper Jaffray Healthcare Conference on Tuesday November 27, 2018 at 11:30 am ET. The conference is being held at the Lotte New York Palace in New York.

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Nicox Postpones NASDAQ Listing Due to Market Volatility

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that due to the extreme volatility of the financial markets, it has decided to postpone its dual listing on Nasdaq, concluding that it would not be in the interest of their existing shareholders at this time. The purpose of a Nasdaq listing is to allow the extensive U.S.

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Nicox Third Quarter 2018 Business Update and Financial Highlights

  • NCX 470 Phase 2 clinical study initiated in Q3 2018 for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension
  • Net revenue from VYZULTA® sales increased by 66% compared to Q2 2018

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company,

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Nicox and Fera Pharmaceuticals to Focus on a Rare Disease Indication for Naproxcinod

  • Nicox and Fera Pharmaceuticals have amended their 2015 agreement for naproxcinod
  • Development, under the responsibility of Fera, will now focus on an undisclosed rare disease, which could potentially lead to an orphan drug designation for naproxcinod
  • Potential sales-based milestone increased to $40 million if annual sales reach $1 billion

Sophia Antipolis,

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Nicox First Half 2018 Financial Results and Business Update

  • NCX 470 Phase 2 clinical study initiated in Q3 2018
  • NCX 4251 on track for U.S. IND filing in Q1 2019 to enable first-in-human Phase 2 clinical study

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmic company, today reported the financial results for the Nicox Group for the six months ending June 30,

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Nicox Announces Intention to Conduct a Registered Offering on NASDAQ in the United States

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmic company, announced today that it has previously confidentially submitted a draft registration statement on Form F-1 to the U.S. Securities and Exchange Commission relating to the proposed offering of American Depository Shares (ADSs) representing Nicox ordinary shares in the United States. The timing, number of ADS representing ordinary shares and price of the proposed offering have not yet been determined.

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Nicox Initiates Phase 2 Study of NCX 470 in Open-Angle Glaucoma and Ocular Hypertension

  • Study to randomize 420 patients in clinical sites across the U.S.
  • Top-line results expected H2 2019
  • Targets $5 billion worldwide glaucoma market1

Sophia Antipolis, France / Research Triangle Park, NC, United States
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced the initiation of a Phase 2 clinical study evaluating NCX 470,

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Nicox Second Quarter 2018 Business Update and Financial Highlights

release at 7:30 am CET Sophia Antipolis, France Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today provided operational highlights and upcoming milestones, as well as revenues and cash position for Nicox and its subsidiaries (the “Nicox Group”) as of June 30, 2018. Michele Garufi, Chairman and Chief Executive Officer of Nicox, stated,…

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Nicox Highlights Recent Progress with Key Programs and Activities

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today provided a business update and highlighted recent progress with key programs and activities.
As expected, the first half of 2018 has seen important progress with our primary research and development projects,” said Michele Garufi, Chairman and Chief Executive Officer of Nicox.

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Nicox Announces Research Collaboration on Novel Ophthalmic Therapeutics with Ironwood Pharmaceuticals

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced its entry into a research collaboration with Ironwood Pharmaceuticals, Inc. (“Ironwood’), a commercial biotechnology company, focused on combining Ironwood’s expertise in soluble guanylate cyclase (sGC) and Nicox’s proprietary nitric oxide (NO)-donating research platform to generate novel compounds in order to identify potential new therapeutics for the treatment of certain ophthalmic conditions.

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Nicox to present at the 2018 BIO International Convention

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced that Emmet Purtill, Senior Director Business Development, will present at the 2018 BIO International Convention on Wednesday June 6, 2018 at 11:15 a.m. Eastern Time. The conference is being held at the Convention & Exhibition Center in Boston.
The presentation will be available on Nicox website (www.nicox.com) in “Presentations &

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Nicox Provides First Quarter 2018 Business and Financial Results

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today provided an overview of its corporate activities and milestones, as well as revenues and cash position for the Nicox Group as of March 31, 2018.
The early months of 2018 marked a time of growth for Nicox, with the expansion and relocation of our U.S.

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Nicox: 2018 Extraordinary Shareholder Meeting

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, informs its shareholders that the ordinary general meeting was held on May 3, 2018 and all resolutions were approved. The extraordinary general meeting convened on first call could not be held as the quorum required by law was not reached.
The shareholders are thus convened on second call for an extraordinary general meeting on the same agenda on Thursday May 24,

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Nicox announces the presentation of scientific data for NCX 667 at ARVO 2018

  • NCX 667 demonstrates robust, dose-dependent lowering of intraocular pressure in various normotensive and hypertensive ocular models

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), an international ophthalmology company, today announced a poster presentation highlighting scientific data for NCX 667, a novel nitric oxide (NO) donating compound, at the Association for Research in Vision and Ophthalmology (ARVO) 2018 Annual Meeting,

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Nicox: Opening of U.S. Development Office in Research Triangle Park, North Carolina

  • Company to relocate its growing U.S. development operations to the North Carolina biotech hub in Research Triangle Park
  • Nicox Research Triangle Park team strengthens and expands Nicox’s development capabilities, with a focus on advancing NCX 470 and NCX 4251

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), an international ophthalmology company,

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Nicox Ordinary and Extraordinary General Meetings convened on May 3, 2018

Dear Shareholder,
I am writing to you to request your continued support for Nicox by voting in the upcoming Nicox Ordinary and Extraordinary General Meetings to be convened on May 3, 2018.
2017 was a pivotal year for Nicox, marked by the approval of two of our assets by the U.S. Food and Drug Administration. VYZULTA® licensed worldwide to Bausch + Lomb,

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Nicox to Present at Upcoming Conferences

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), international ophthalmology company, today announced that members of Nicox’ management team will participate in the following conferences in April 2018:

  • Gavin Spencer, Executive Vice President, Chief Business Officer, will present at the H.C. Wainwright Global Life Sciences Conference on Tuesday, April 10, 2018 at 9:00 a.m.
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Nicox: 2018 Extraordinary and Ordinary Shareholder Meetings

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), international ophthalmology company, has convened an ordinary and an extraordinary shareholder meeting on Thursday May 3, 2018 at 2:00 pm CEST in the offices of BuroClub – Drakkar 2 – Bâtiment D – 2405 route des Dolines – 06560 Valbonne Sophia Antipolis – France.
The documents mentioned in articles R.225-73-1 of the French Code de commerce,

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Nicox Announces Improved Financial Terms from Bausch + Lomb for VYZULTA

  • Increase in Royalties by 1% on Annual VYZULTA® Global Sales Revenue Over $300 Million
  • Additional $20 Million in Potential Milestones

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), international ophthalmology company, today announced an amendment to its global licensing agreement with Bausch + Lomb Incorporated, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International Inc.,

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Nicox to Present at Two Upcoming Investor Conferences in the United States

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), international ophthalmology company, today announced that Michele Garufi, Chairman and Chief Executive Officer of Nicox, will present at the following investor conferences in March 2018 in the United States:

  • Cowen and Company 38th Annual Health Care Conference on Tuesday, March 13, 2018 at 9:20 a.m.
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Nicox présent à la réunion Biotech Agora le 5 mars 2018 à Paris

Dans le cadre des soirées évènements organisées par Biotech Agora, une réunion débat avec la société Nicox est organisée le lundi 5 mars à 18h30 à l’hôtel Bedford, 17 rue de l’Arcade, 75008 Paris, au cours de laquelle vous aurez l’opportunité d’échanger avec Mr Michele Garufi, Président Directeur Général de Nicox, qui présentera les actualités de la Société,

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Nicox Appoints Tomas Navratil, Ph.D., as Head of Development

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), international ophthalmic company, today announced the appointment of Tomas Navratil, Ph.D., as Vice President and Head of Development, effective January 1, 2018. In this newly-created position, Dr. Navratil will be responsible for leading all of the Company’s non-clinical and clinical development activities, and will report to Michael Bergamini,

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2017

Nicox Recaps 2017 Achievements, Provides Update on Commercial Availability of VYZULTA and Outlines 2018 Activities

  • Nicox joins the select group of European R&D companies with U.S. FDA approved products, with two products approved in 2017
  • Valeant Pharmaceuticals International, Inc.’s wholly owned subsidiary, Bausch + Lomb, a leading global eye health company, announced yesterday that it has begun distributing VYZULTA™ (latanoprostene bunod ophthalmic solution), 0.024% to wholesale pharmaceutical distributors across the United States
  • VYZULTA® is the first approved product based on Nicox’s NO-donating research platform
  • Resources in 2018 will be focused on advancing Nicox’s pipeline candidates NCX 470 and NCX 4251 towards mid-stage clinical development and on progressing its next generation of discovery-stage NO-donating compounds targeting glaucoma into preclinical development

Sophia Antipolis,

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Shareholder letter

November 6, 2017
Dear Nicox Shareholder,
It is an important moment for all of us, perhaps the most important since the foundation of Nicox.  The first drug generated by our proprietary NO-donating research platform has been approved for launch in the world’s largest, most prestigious and challenging pharmaceutical market, the United States.
As I am sure you are aware,

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Nicox to Host Investor Conference Call on November 3. 2017. Follows the November 2. 2017 Approval of VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% by the U.S. FDA

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124, COX), the international ophthalmic company, will host a conference call on November 3. 2017, at 3pm CET/ 2pm UK/ 10 am ET following the announcement of the approval of VYZULTA® by the U.S. FDA.
To access the conference call, please dial +33 (0)1 76 77 22 74 (France) or +44 (0)330 336 9105 or +1 323 794 2423 (International) and conference code number 5961849≠.

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Nicox Highlights VYZULTA approval, Latest Corporate and Financial Developments, and Upcoming Pipeline Initiatives

  • VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% Approved by U.S. Food and Drug Administration (FDA); Bausch + Lomb to Launch by Year End
  • Revenue Stream to Support Advancement of NCX 470 and NCX 4251 into Phase 2 Studies; Investigational New Drug (IND) applications to be submitted in 2018

Sophia Antipolis, France
Nicox SA (Euronext Paris: FR0013018124,

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BAUSCH + LOMB AND NICOX ANNOUNCE FDA APPROVAL OF VYZULTA™ (LATANOPROSTENE BUNOD OPHTHALMIC SOLUTION), 0.024%

First Prostaglandin Analog with one of its Metabolites Being Nitric Oxide Approved to Provide Consistent and Sustained IOP Reduction Through 12 Months   
LAVAL, QUEBEC and SOPHIA ANTIPOLIS, FRANCE, Nov. 2, 2017 – Valeant Pharmaceuticals International, Inc.’s (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch + Lomb, a leading global eye health company, and Nicox S.A.

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Nicox Provides Third Quarter 2017 Business Update and Cash Position

  • ZERVIATETM1 U.S. Rights Licensed to Eyevance Pharmaceuticals – Launch Expected Late 2018
  • Two New Collaborations in Place for Development of Ophthalmic Sustained Release Pipeline Assets
  • Cash Balance of €47.1 Million as of September 30, 2017

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), international ophthalmic company,

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Nicox Enters Research Collaboration with Re-Vana Therapeutics on its Next Generation of Stand-alone NO-donors in a Novel Sustained Release Ophthalmic Formulation

Sophia Antipolis, France and Belfast, Northern Ireland
Nicox SA (Euronext Paris: FR0013018124, COX), the international ophthalmic company, and Re-Vana Therapeutics Ltd, ocular pharmaceutical and drug delivery company, today announced that they have entered into a research collaboration to explore combining Nicox’s next generation of stand-alone nitric oxide (NO)-donors with Re-Vana’s EyeLief™ long-acting photo-crosslinked biodegradable drug delivery platform for the reduction of intraocular pressure (IOP),

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Nicox and pSivida Enter Strategic Collaboration Agreement to Develop Sustained Release Drug to Lower Intraocular Pressure in Patients with Glaucoma

Focus will be on Combining Nicox’s New Nitric Oxide Donating Compounds with pSivida’s Bioerodible Sustained Release Delivery Technology  
Sophia Antipolis, France and Watertown, Mass, United States
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, and pSivida Corp, (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug products and technologies, today announced their entry into a collaboration agreement to explore the potential of combining Nicox’s nitric oxide (NO)-donating compounds with pSivida’s bioerodible sustained release drug delivery system,

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Nicox to present at the Cantor Fitzgerald 2017 Global Healthcare Conference

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced that Michele Garufi, Chairman and Chief Executive Officer of Nicox, will present at the Cantor Fitzgerald 2017 Global Healthcare Conference on Tuesday, September 26th, 2017 at 1:05 p.m. Eastern Time.  The conference is being held at the InterContinental New York Barclay Hotel.

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Nicox first half 2017 business and financial update

  • ZERVIATETM (cetirizine ophthalmic solution), 0.24% New Drug Application (NDA) approved
  • Investigational New Drug (IND) submissions for NCX 470 for IOP lowering and NCX 4251 for blepharitis planned for H1 2018
  • Bausch + Lomb responded to VYZULTA® (latanoprostene bunod ophthalmic solution), 0.024% Complete Response Letter (CRL) received from U.S.
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Ordinary Shareholder meeting on September 4, 2017

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, informs its shareholders that the ordinary shareholder meeting convened on first call on August 21, 2017 could not be held as the quorum required by law was not reached.
The shareholders thus are convened on second call for an Ordinary shareholder meeting on the same agenda on Monday September 4,

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Nicox announces that its Exclusive Licensee Submits response to CRL for latanoprostene bunod ophthalmic solution, 0.024%

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced that its exclusive licensee has informed Nicox that it has submitted a response to the Complete Response Letter (CRL) received from the U.S. Food and Drug Administration (FDA) on August 7, 2017 concerning the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution,

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Shareholder Letter

Dear Nicox Shareholder,
You may have seen the announcement (attached) of our increase of capital dedicated to a specific category of investors and you might wonder why we did it just on the back of the very disappointing news of a further, unexpected delay on the decision regarding the approval of VYZULTA.
We at Nicox, the Board and the management,

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Nicox announces €26.25 million financing

Not for distribution in or into the United States of America, Canada, Japan or Australia, except as permitted by applicable law
Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced a reserved capital increase of ordinary shares of the Company to a specific category of investors. The gross proceeds from the financing are €26.25 million,

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Press Release concerning latanoprostene bunod ophthalmic solution, 0.024%

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, has been informed by its partner Bausch + Lomb (a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.) of the receipt of a Complete Response Letter from the U.S. FDA concerning latanoprostene bunod ophthalmic solution, 0.024% which resulted in the attached press release issued by Valeant yesterday.

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Ordinary Shareholder meeting of August 21, 2017 – Conditions of availability of the preparatory documents

Sophia Antipolis, France
The shareholders of Nicox are convened to an ordinary shareholder meeting on first call on Monday August 21, 2017 at 2:00 pm CET in the offices of BuroClub – Drakkar 2 – building D – 2405 route des Dolines – 06560 Valbonne Sophia Antipolis – France.
The notice of convening containing the agenda and the draft resolutions was published in the BALO on July 17,

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Nicox to present at the 2017 BIO International Convention

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced that Emmet Purtill, Director Business Development, will present at the 2017 BIO International Convention on Thursday June 22 , 2017 at 11:15 a.m. Pacific Time. The conference is being held at the Convention Center in San Diego.
The presentation will be available on Nicox website (www.nicox.com) in “Presentations &

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Nicox announces the issuing and admission to trading on the Euronext regulated market in Paris of 597,897 new shares awarded to former Aciex shareholders following the US FDA’s approval of the new drug application in the US for ZERVIATE (cetirizine ophthalmic solution) 0.24%.

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), 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 (Food and Drug Administration) of the new drug application in the US for ZERVIATE (cetirizine ophthalmic solution) 0.24% (see the Company’s press release of 31 May 2017),

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Nicox receives FDA approval of ZERVIATE (cetirizine ophthalmic solution) 0.24%

  • First approved US NDA for Nicox
  • First topical ocular formulation of the antihistamine cetirizine
  • U.S. patent protection until at least 2030
  • Partnering discussions underway for U.S. commercialization rights

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced that the U.S.

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Nicox’s Extraordinary Shareholder Meeting on May 30, 2017

Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, informs its shareholders that the ordinary shareholder meeting was held on May 16, 2017 and all resolutions were approved. The extraordinary shareholder meeting convened on first call could not be held as the quorum required by law was not reached.
The shareholders thus are convened on second call for an Extraordinary shareholder meeting on same agenda on Tuesday May 30,

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Mrs. Lauren P. Silvernail appointed to Nicox Board of Directors

Renewal of the terms of office of Mrs. Birgit Stattin Norinder and Michele Garufi
Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced the appointment of Mrs. Lauren P. Silvernail to the Company’s Board of Directors, for a period of four years. Mrs. Silvernail brings to Nicox more than 30 years of experience in leading business growth and financial strategies for life science companies,

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Nicox announces the presentation of scientific data on NCX 667 at ARVO 2017

NCX 667’s sustained IOP-lowering properties following repeated dosing in two preclinical models of glaucoma highlighted
Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced a poster presentation highlighting scientific data for NCX 667, a novel nitric oxide (NO) donating compound, at the Association for Research in Vision and Ophthalmology (ARVO) 2017 Annual Meeting,

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Nicox to present at the Deutsche Bank 42nd Annual Health Care Conference

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced that Gavin Spencer, Executive Vice President, Corporate Development, will present at the Deutsche Bank 42nd Annual Health Care Conference on Wednesday, May 3rd, 2017 at 9:20 a.m. Eastern Time. The conference is being held at the InterContinental Boston Hotel.
The presentation will be available on Nicox website (www.nicox.com) in “Presentations &

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Nicox announces PDUFA date for ZERVIATE NDA

  • PDUFA date set for September 8, 2017

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced that the U.S. Food and Drug Administration (FDA) has set a PDUFA date of September 8, 2017 for its decision on the New Drug Application (NDA) for ZERVIATE1 (cetirizine ophthalmic solution) 0.24%,

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Nicox’s Extraordinary and Ordinary Shareholder Meetings

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, has convened an ordinary and extraordinary shareholder meeting on Tuesday May 16, 2017 at 2:00 pm CET in the offices of Drakkar – 2405 route des Dolines – 06560 Valbonne Sophia Antipolis – France.
The documents mentioned in articles R.225-73-1 of the French Code de commerce,

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Nicox to present at the 16th Annual Needham Healthcare Conference

Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced that Gavin Spencer, Executive Vice President, Corporate Development, will present at the 16th Annual Needham Healthcare Conference on Wednesday, April 5, 2017 at 9:20 a.m. Eastern Time. The conference is being held at the Westin Grand Central in New York.
The presentation will be available on Nicox website (www.nicox.com) in “Presentations &

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Nicox: Business Update and 2016 Financial Results

  • Two potential U.S. product approvals for Vyzulta™1 (latanoprostene bunod ophthalmic solution) 0.024% and ZERVIATE2 (cetirizine ophthalmic solution) 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 €28.9 million as of December 31,
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Bausch + Lomb announce PDUFA date for novel glaucoma candidate latanoprostene bunod

PDUFA date set for August 24, 2017
LAVAL, QUEBEC and SOPHIA ANTIPOLIS, FRANCE – March 20, 2017 – 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 date of August 24,

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Nicox resubmits AC-170 (ZERVIATE) 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

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced the resubmission of the New Drug Application (NDA) for AC-170,

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Nicox to participate at two upcoming investor conferences

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), 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.

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Bausch + Lomb and Nicox resubmit US New Drug Application for novel glaucoma candidate latanoprostene bunod

LAVAL, QUEBEC and SOPHIA ANTIPOLIS, FRANCE – FEBRUARY 27, 2017 – Valeant Pharmaceuticals International, Inc.’s (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. (NYSE Euronext Paris: COX) today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for latanoprostene bunod ophthalmic solution,

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Nicox announces the presentation of NCX 667 scientific data at AOPT 2017

New preclinical data demonstrate NCX 667’s robust IOP lowering properties
Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced that preclinical results from its novel nitric oxide (NO) donating compound, NCX 667, were presented at the Association for Ocular Pharmacology and Therapeutics (AOPT) 13th Scientific Meeting, held from February 16-19,

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Nicox to present at the 6th Annual LEERINK Partners Global Healthcare Conference

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced that Michele Garufi, Chairman and CEO of Nicox, will be presenting at the 6th Annual LEERINK Partners Global Healthcare Conference on Thursday, February 16th, 2017 at 3:00 p.m. Eastern Time. The conference is being held at the Lotte New York Palace Hotel.

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Nicox provides clinical and regulatory update for NCX 470 for IOP lowering

  • Positive pre-IND meeting with FDA completed
  • Expect to file IND in Q4 2017
  • First-in-Human Phase 2 clinical study expected to start in Q1 2018

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today provided certain regulatory and clinical updates for NCX 470,

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Nicox provides clinical and regulatory update for NCX 4251 in blepharitis

  • Pre-IND meeting on NCX 4251 with FDA completed
  • Phase 2 expected to start Q4 2017

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today provided certain regulatory and clinical updates for NCX 4251, its novel ophthalmic suspension of fluticasone propionate nanocrystals being developed for the first time as a topical treatment for acute exacerbation of blepharitis.

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2016

Nicox to present at the Stifel 2016 Healthcare Conference

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0000074130, COX), today announced that Michele Garufi, Chairman and CEO of Nicox, will be presenting at the Stifel 2016 Healthcare Conference on Tuesday, November 15, 2016, at 11:00 a.m. Eastern Time. The conference is being held at the Lotte New York Palace Hotel.
The presentation will be available on the Company’s website (www.nicox.com) in “News &

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Nicox Provides Update on Latanoprostene bunod and AC-170

  • Latanoprostene bunod: Bausch + Lomb anticipates launch mid-20171

 

  • AC-170: Nicox to meet with the FDA concerning resubmission of AC-170 NDA and expects FDA feedback by early 2017

 
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today provided an update on the regulatory status of its key projects,

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Nicox third quarter 2016 business update and cash position

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today provided an update on its activities and cash position.
We expect to further advance our position as a leading ophthalmic R&D company with the anticipated FDA decisions on latanoprostene bunod, which is licensed worldwide to Bausch + Lomb, and AC-170,

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Nicox Receives Complete Response Letter from the FDA Related to GMP on NDA for AC-170

  • Safety and efficacy data submitted in the NDA have not resulted in the FDA requesting any further clinical or non-clinical testing for approval
  • FDA letter related solely to GMP at third party active pharmaceutical ingredient supplier facility

 
Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company,

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WARNING

We regretfully announce a fraudulent use of the name Nicox with respect to alleged job offers in our Group, in particular in the United-States. All our job offers appear in the “Working with us” section of our website. Nicox Ophthalmics, Inc., our American subsidiary, is not currently recruiting.
All job offers that are not listed in the “Working with us” section of our website should be considered spam and all entities of the Group decline any and all liability in this respect.

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Shareholder Letter

Dear Shareholder,
I am writing to you personally today, following comments that we have received and noted, concerning the status of latanoprostene bunod and to assure you that we are fully engaged on the subject following the receipt of the US Food and Drug Administration (FDA) letter by Bausch + Lomb in July.
We are in close discussion with the team at the headquarters of Bausch + Lomb however certain information cannot be publicly disclosed by Nicox at the moment due to the fact that it relates to discussions between Bausch + Lomb and the FDA.

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Nicox first half 2016 business and financial update

  • Latanoprostene bunod licensee Bausch + Lomb receives Complete Response Letter from U.S. FDA pertaining to B+L manufacturing facility; no efficacy or safety concerns or additional clinical trials regarding the compound identified for approva
  • AC-170 NDA under FDA Priority Review approval process
  • Cash position of €34.1 million1: Nicox sufficiently financed through completion of clinical proof-of-concept trials for pipeline assets NCX 4251 and NCX 470 by end of 2018
  • Refocusing on R&D-only allows significant reduction in operating costs going forward

………………………………………………………………………
Sophia Antipolis,

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Nicox to present at the 18th Annual Rodman & Renshaw Global Investment Conference

Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic R&D company, today announced that Gavin Spencer, EVP Corporate Development, will present at the 18th Annual Rodman & Renshaw Global Investment Conference on Tuesday, September 13, 2016 at 2:35 PM Eastern Time. The conference is being held at the Lotte New York Palace Hotel in New York City.

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Nicox completes transfer of Commercial Operations to new pan-European Ophthalmic Specialty Pharmaceutical Company led by GHO Capital

Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced the completion of the transfer of its European and International commercial operations and related late-stage development programs to a newly-founded, private, pan-European ophthalmic specialty pharmaceutical company. This transfer includes the affiliates Nicox Pharma (France), together with its Spanish and UK operations,

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Shareholder Letter

Dear Nicox Shareholder,
As you may have noticed this has been without doubt an intense few weeks for Nicox, with the US FDA granting Priority Review for our New Drug Application (NDA) for AC-170 on June 18th, followed by the signing of an innovative agreement with GHO Capital for the future development of our European Commercial operations on July 4th.

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Nicox raises €18 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

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Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced a reserved capital increase of ordinary shares of the Company to a specific category of investors. The proceeds from the financing will principally be used to drive the development of NCX 4251,

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Press Release concerning latanoprostene bunod

Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, has been informed by its partner Bausch + Lomb (a wholly-owned subsidiary of Valeant Pharmaceuticals International, Inc.) of the receipt of a Complete Response Letter from the U.S. FDA concerning latanoprostene bunod which resulted in the attached press release issued by Valeant today.

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Nicox to present at Cantor Fitzgerald’s 2nd Annual Healthcare Conference

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), today announced that Gavin Spencer, Executive Vice President Corporate Development of Nicox, will be presenting at the Cantor Fitzgerald’s 2nd Annual Healthcare Conference on Wednesday July 13, 2016, at 1:30 pm Eastern Time. The conference is being held at Le Parker Meridien hotel in New York.
The presentation will be available on the Company’s website (www.nicox.com) in “News &

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Bausch + Lomb and Nicox Announce the Publication of Latanoprostene Bunod Ophthalmic Solution 0.024% Phase 3 Study Results in American Journal of Ophthalmology

Second Published Phase 3 Trial to Demonstrate Significantly Greater Efficacy vs. Timolol Maleate 0.5%
LAVAL, QUEBEC and SOPHIA ANTIPOLIS, FRANCE – JULY 6, 2016 – Valeant Pharmaceuticals International, Inc.’s (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch + Lomb, a leading global eye health company, and Nicox S.A. (Euronext Paris: COX) today announced that the results of a Phase 3 study for latanoprostene bunod (LBN) ophthalmic solution 0.024% have been published in the American Journal of Ophthalmology.

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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
  • Nicox to receive a €9 million upfront cash payment and a minority stake in the new company
  • Nicox to focus resources on unencumbered R&D pipeline in ophthalmology
    ………………………………………………………………………………………….
    Sophia Antipolis, France.

Nicox S.A.

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Nicox added to Russell Global Index

Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, today announced that it was added to the Russell Global Index when the Russell Investment Group reconstituted its family of U.S. indexes effective today, June 27, 2016.
Membership in the Russell Global Index, which remains in place for one year, means automatic inclusion in the appropriate large-cap,

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U.S. FDA grants Priority Review for Nicox’s AC-170 New Drug Application

FDA assigns Prescription Drug User Fee Act (PDUFA) goal date of October 18, 2016
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Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for AC-170, a novel, proprietary, cetirizine eye drop formulation, for the treatment of ocular itching associated with allergic conjunctivitis.

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Nicox’s Ordinary Shareholder Meeting

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, has convened an Ordinary shareholder meeting on a second call and on same agenda on Tuesday June 21, 2016 at 2:00 pm CET at BuroClub – room Colomb – Drakkar 2 – Bâtiment D – 2405 route des Dolines – 06560 Valbonne Sophia Antipolis – France as the quorum required by law was not reached on first call on June 7,

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Nicox first quarter 2016 financial and business update

  • Revenue of €3.5 million, with growth of over 60% in the first quarter 2016
  • NDAs in the U.S. for latanoprostene bunod and AC-170 under review at the FDA

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Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today reported its first quarter 2016 revenues and cash position and provided an update on its activities.

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Nicox announces the presentation of scientific data at ARVO 2016

Study results on Nicox compounds presented, including internally-developed pipeline candidates NCX 667, NCX 1653 and NCX 4240, as well as latanoprostene bunod results presented by licensee Bausch + Lomb
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Sophia Antipolis, France 
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced the presentation of seven posters highlighting scientific data for its internally developed and partnered pipeline candidates at the Association for Research in Vision and Ophthalmology (ARVO) 2016 Annual Meeting,

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Nicox’s Ordinary Shareholder Meeting

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, has convened an ordinary shareholder meeting on Tuesday June 7, 2016 at 2:00 pm CET at BuroClub – room Colomb – Drakkar 2 – Bâtiment D – 2405 route des Dolines – 06560 Valbonne Sophia Antipolis – France.
The documents mentioned in articles L.225-115,

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Nicox submits New Drug Application for AC-170 to U.S. FDA

Dossier submitted, with a request for Priority Review, for the treatment of ocular itching associated with allergic conjunctivitis
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Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced the submission, through its American subsidiary Nicox Ophthalmics, Inc., of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of AC-170,

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Nicox: 2015 Financial Results and Business Update

  • Latanoprostene bunod New Drug Application (NDA) under review by the U.S. Food & Drug Administration (FDA) with a PDUFA (Prescription Drug User Fee Act) date of July 21, 2016
  • AC-170 NDA to be submitted early Q2, 2016
  • 2015 revenues €10 million, a 67% increase vs. 2014
    ……………………………………………………………………………………….

Sophia Antipolis,

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Nicox to present at the 15th Annual Needham Healthcare Conference

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX) today announced that Michele Garufi, Chairman and CEO of Nicox, will be presenting at the 15th Annual Needham Healthcare Conference on Tuesday, April 12, 2016, at 1:40 pm Eastern Time. The conference is being held at The Westin NY Grand Central Hotel in New York City.
A live webcast of the presentation can be accessed on the Company’s website (www.nicox.com) in “News &

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Nicox reports strong revenue growth in 2015 and provides corporate update

  • 2015 annual revenues grew by 65% to €9.9 million
  • NDA filing for AC-170 expected in early Q2 2016

 
Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today reported the unaudited revenues and cash position for the full year 2015 and provided an update on its corporate activities.

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Nicox to present at the 18th Annual BIO CEO & Investor Conference

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX) today announced that Michele Garufi, Chairman and CEO of Nicox, will be presenting at the 18th Annual BIO CEO & Investor Conference on Tuesday, February 9, 2016, at 10:00 a.m. Eastern Time. The conference is being held at The Waldorf Astoria hotel in New York City.
A live webcast of the BIO CEO &

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Nicox out-licenses OTC asset AC-120 to Ora, Inc.

  • Transaction enables Nicox to leverage OTC-directed asset from Aciex acquisition, while focusing resources on its ophthalmic pipeline assets targeting major prescription markets
  • Nicox to receive payment on approval and a share of future revenue from sales of AC-120
  • Ora to finance all development activities
  • Upcoming Phase 2/3 in morning eyelid swelling or ‘puffiness’

Sophia Antipolis,

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2015

Nicox completes reverse stock split and provides business update

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0013018124, COX), the international ophthalmic company, today announced the completion of its reverse stock split and provided an update regarding ongoing corporate initiatives and activities.
Completion of the 5-for-1 reverse stock split
The Company has completed the previously announced 5-for-1 reverse split of its common stock, effective today. The reverse stock split,

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Nicox to present at the Stifel 2015 Healthcare Conference

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0000074130, COX), today announced that Michele Garufi, Chairman and CEO of Nicox, will be presenting at the Stifel 2015 Healthcare Conference in New York City on Wednesday November 18, 2015, at 11:45 am EST (5:45pm CET) .
A live webcast of the presentation can be accessed under the “Presentations &

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Nicox and Fera Pharmaceuticals sign exclusive license agreement for naproxcinod in the U.S.

Nicox eligible to receive up to $35 million in commercial milestones, plus 7% royalties on future sales
Sophia Antipolis, France and Locust Valley, New York
Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, and Fera Pharmaceuticals, a privately-held specialty pharmaceutical company, announced today that they have entered into an exclusive license agreement for the development and commercialization of Nicox’s naproxcinod,

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Nicox third quarter 2015 financial and business update

Total sales increased by almost 120% over 2014
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Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, today reported its revenues for the nine month to September 30, 2015 as well as its cash position, and provided an update on its activities.
Michele Garufi, Chairman and Chief Executive Officer of Nicox,

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Nicox announces reverse stock split

Important step in the Company’s strategic initiative to increase international awareness and visibility
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Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, today announced that its Board of Directors is implementing a 5-for-1 reverse stock split, as approved by Nicox’s shareholders at the October 13, 2015 Extraordinary General Meeting. The reverse stock split will become effective on December 3,

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Nicox to present at the 14th Annual BIO Investor Forum

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0000074130, COX), today announced that Michele Garufi, Chairman and CEO of Nicox, will be presenting at the 14th Annual BIO Investor Forum in San Francisco on Tuesday October 20, 2015, at 10:00 am Pacific Time.
A live webcast of the BIO Investor Forum presentation can be accessed under the “Presentations &

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Nicox proposes reverse stock split and convenes Extraordinary Shareholder Meeting

Sophia Antipolis, France.
Download the presentation
Nicox S.A. (Euronext Paris: FR0000074130, COX) has convened an Extraordinary Shareholder Meeting on Tuesday October 13, 2015 at 2:00 pm CET, at the Hotel Sophia Country Club – 3550 Route des Dolines, 06410 Biot (Sophia Antipolis), France.
The first resolution submitted to the vote of the shareholders is a delegation of powers to the Board of Directors to carry out a reverse stock split with a 5 to 1 ratio1.

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Nicox first half 2015 highlights

• Product pipeline on track for near-term major progress
       o VESNEO™ NDA submitted by Valeant
       o Three further regulatory submissions planned by Nicox within the next 12 months
• Accelerating development of additional NO-donating ophthalmology programs
• Revenues from existing products €4.6 million in H1 2015, up 114% from H1 2014 ………………………………………………………………………………………….
Sophia Antipolis, France
Nicox S.A.

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Bausch + Lomb confirms submission of Vesneo™ NDA to US FDA

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, today noted the confirmation by Valeant Pharmaceuticals International, Inc’s. (NYSE: VRX and TSX: VRX) wholly owned subsidiary, Bausch + Lomb,that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for VESNEO™ (latanoprostene bunod ophthalmic solution 0.024%),

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Nicox provides business update at Ordinary and Extraordinary Shareholder Meetings

  • Lead clinical candidates Vesneo™ and AC-170 on track for NDA submission in the United States
  • New preclinical nitric oxide-donating programs moving forward

………………………………………………………………………………………….Sophia Antipolis, France
Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, today provided an update ahead of its Ordinary and Extraordinary Shareholder Meetings, convened today, June 3,

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Nicox to present at the Jefferies 2015 Healthcare Conference

Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0000074130, COX), today announced that Gavin Spencer, EVP Corporate Development of Nicox, will be presenting at the Jefferies 2015 Healthcare Conference in New York on Thursday June 4th at 11:30 am EDT.
Gavin Spencer will also be available for one-one-one meetings at the conference.

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Promising preclinical data on new compounds for glaucoma presented at ARVO by Nicox

Novel nitric oxide donors NCX 667 and NCX 470 effective in lowering IOP
Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, today announced that promising preclinical results from two novel nitric oxide-donors, NCX 667 and NCX 470, were presented at the Association for Research in Vision and Ophthalmology (ARVO) 2015 Annual Meeting,

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Nicox’s Extraordinary and Ordinary Shareholder Meetings

Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0000074130, COX), has convened an ordinary and extraordinary shareholder meeting on Wednesday June 3, 2015 at 2:00 pm CET at the Hotel Mercure – rue Albert Caquot – 06560 Sophia Antipolis – France.
The documents mentioned in articles L.225-115, R. 225-81 and R. 225-83 of the French Code de commerce,

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Nicox first quarter 2015 financial and business update

Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: FR0000074130, COX), the international ophthalmic company, today reported its first quarter 2015 revenues and cash position and provided an update on its activities.
“We enjoyed an excellent start to 2015 across the different business activities of our Group” said Michele Garufi, Chairman and CEO of Nicox. “The successful financing completed in March demonstrated support for our strategy from international specialist investors,

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Nicox 2014 Financial Results and Business Update

  • A year of strategic progress:
    • Positive phase 3 results for Vesneo™ (Bausch + Lomb); NDA submission on track for Q2 2015
    • Significant strengthening of ophthalmic therapeutics pipeline
    • Acquisition of Aciex Therapeutics, Doliage and Carragelose® eye drop (Xailin Viral)
    • In-licensing of AzaSite® and BromSite™ in Europe (Q1 2015)
  • 2014 revenues €6.0 million vs.
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Nicox receives Orphan Drug Designation from FDA for naproxcinod in Duchenne Muscular Dystrophy

Sophia Antipolis, France
Nicox S.A. (Euronext Paris: COX) today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for naproxcinod for the treatment of Duchenne Muscular Dystrophy (DMD). ODD is a status granted to drugs or biological products that treat rare diseases or conditions. The designation qualifies the sponsor of the drug for various development incentives,

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Nicox announces financing of €27 million to support its growth strategy

Not for distribution in or into the United States of America, Canada, Japan or Australia, except as permitted by applicable law
Participation of life science specialized investors, mainly from the US, strengthens shareholder base
Sophia Antipolis, France.
Nicox S.A. (Euronext Paris: COX), the international ophthalmic company, today announced a reserved capital increase of ordinary shares of the Company to specific categories of investors.

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Nicox signs exclusive license agreement with InSite Vision for AzaSite® and BromSite™ in Europe

  • InSite grants Nicox exclusive license for AzaSite® (1% azithromycin), BromSite™ (0.075% bromfenac) and AzaSite Xtra™ (2% azithromycin) in Europe, Middle East and Africa
  • European regulatory filings for AzaSite® and BromSite™ planned by Q1 2016

Sophia Antipolis, France
Nicox S.A. (NYSE Euronext Paris: COX) today announced the signature of a license agreement with InSite Vision Inc.

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Nicox holds successful pre-NDA meeting with FDA on AC-170 clinical package

Sophia Antipolis, France.
Nicox S.A. (NYSE Euronext Paris: COX), the international ophthalmic company, today announced that it has held a positive pre-New Drug Application (NDA) meeting with the United States Food and Drug Administration (FDA) regarding AC-170, a topical ocular formulation of cetirizine developed for the treatment of ocular itching associated with allergic conjunctivitis. The purpose of the meeting was to discuss the clinical package for AC 170,

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Launch of new website www.nicox.es

Nicox is pleased to announce the launch of a new website dedicated to the group’s operations in Spain: www.nicox.es. This website is designed to provide corporate information as well as detailed information on our products to Spanish eye care practitioners. 

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