nieuws Novacyt

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voda
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Novacyt S.A.: Launch of CE-IVD Marked novel coronavirus test

February 17, 2020 07:30 AM Eastern Standard Time

PARIS & CAMBERLEY, England--(BUSINESS WIRE)--Regulatory News:

Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT) ("Novacyt", the "Company" or the “Group”), an international specialist in clinical diagnostics, is pleased to announce that its molecular diagnostics division, Primerdesign, has launched its CE-Mark molecular test for the clinical detection of the novel coronavirus (COVID-19).

The Directors believe that Primerdesign’s COVID-19 test is the first CE-Mark test for the 2019 strain of novel coronavirus and follows the Company’s rapid launch of its research use only (RUO) coronavirus test on 31 January 2020. As a result of the CE-Mark, the Company’s COVID-19 test can be used directly by laboratories and hospitals for the testing of patients without the need for validation by clinicians. The Company anticipates increased demand for its test for COVID-19 due to this extended use for clinical diagnosis.

Primerdesign has already received requests for quotations for 288,000 CE-Mark tests since they were made available to pre-order on 14 February 2020. The Company has received orders for 40,000 RUO tests and requests for quotations for an additional 35,000 RUO tests prior to the launch of the COVID-19 clinical version. Demand for the tests has come from China, the US and the UK, as well as many other countries around the world.

The Company continues to see a high conversion rate from quotations to orders. However, it is difficult to predict how demand for the test will grow as the epidemic is still in its early stages. Since the initial reports of COVID-19, the Company has invested in manufacturing capacity to meet the current and potential future demand for its tests.

The Primerdesign test is being formally evaluated by public health authorities from five countries and the Company is in discussions with these organisations to potentially support their national screening requirements for COVID-19.

As previously announced, the Company has submitted an application to, and remains in discussion with, the US Food and Drug Administration (FDA) for Emergency Use Approval (EUA) of its test for COVID-19, which would allow laboratories in the US to use the test for clinical diagnosis on a temporary basis. The data generated from the CE-Mark approval will be used to support this application.

Graham Mullis, Chief Executive Officer of Novacyt commented.

“I am very pleased to announce the launch of our COVID-19 CE-Mark test, which we believe is the first CE-Mark approved test for clinical diagnosis of the 2019 strain of the novel coronavirus. As with our research use only test, it can produce a result in less than two hours, with the added efficiency of being able to transport the test at ambient temperatures eliminating the need for cold chain shipping. It is designed to run on multiple instrument platforms commonly used by clinical laboratories around the world, which ensures our COVID-19 test can be used by the largest possible number of clinicians. We look forward to continuing to support clinicians in the fight to contain the spread of the novel coronavirus during this public health emergency.”

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.

- End –

www.businesswire.com/news/home/202002...
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Coronavirus test update Major distribution agreement for COVID-19 test

Paris, France and Camberley, UK – 28 February 2020 – Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, is pleased to provide an update regarding the novel coronavirus (COVID-19) test developed by Primerdesign, its molecular diagnostics division, and announces it has signed a major distribution agreement in Asia and an original
Forecast2006
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LiquidityAgreement Monthly UpdateandTotal Voting RightsParis, France and Camberley, UK –2 March 2020-Novacyt(EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, today announcesits monthlyupdate in relation to ordinary shares traded under its ongoing liquidity agreement with Invest Securities SA(the “Liquidity Agreement”).The Liquidity Agreement is governed by French lawand is further summarised in the ‘notes for editors’ section below.During the period from 1Februaryto 29February2020, Invest Securities purchased 95,050ordinary shares at a maximum price of €1.80and a minimum price of €0.40and sold 121,516ordinary shares at a maximum price of €1.94and a minimum price of €0.49under the Liquidity Agreement.The total number of ordinary shares in the Company,which are held in treasury as at close of business on 29 February2020,is7,050.Total Voting RightsThe total number of ordinary shares in the Company is67,673,567following the issue of equity announced on 19 February 2020. This figure may be used by shareholders as the denominator for calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company pursuant to Article L. 223-7 of the French Commercial Code and the Company's Articles.The Company is not subject to the disclosure guidance and transparency rules made by the Financial Conduct Authority under Part VI of FSMA.For further information, please refer towww.novacyt.comor contact
voda
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'Nederlands' bedrijf dat coronavirus opspoort voor $10 mrd gekocht

Het Amerikaanse Thermo Fisher Scientific TMO:$310,36+1,77% koopt voor $10 mrd (circa €9 mrd) de fabrikant van diagnostische testen Qiagen QN2:€37,30+0,38% . Dat hebben de twee ondernemingen dinsdag bekendgemaakt. De overname is tot dusver de grootste in de farmasector van dit jaar.

Qiagen is van oorsprong een Duits biotechnologiebedrijf met een hoofdkwartier in de buurt van Düsseldorf. De activiteiten van de onderneming zijn ondergebracht in een Nederlandse holding, statutair gevestigd in Venlo. Het bedrijf ontwikkelt en verkoopt diagnostische testen, onder meer voor kanker. Nu is het bedrijf druk met het ontwikkelen van een test voor het coronavirus Covid-19. Dat zou de overname kunnen verklaren.

Snelle coronatest

Topman Marc Casper van Thermo Fisher hint daar op in een toelichting op de overname. Casper stelt dat de aankoop van Qiagen zijn bedrijf in staat stelt 'innovatie te versnellen en opkomende gezondheidskwesties aan te pakken'. In januari begon Qiagen aan een test om het virus op te sporen in lichaamsvloeistoffen. De test wordt nu geëvalueerd in vier ziekenhuizen in China en een in Frankrijk. De diagnose kan volgens Qiagen in ongeveer een uur laten zien of iemand het coronavirus heeft.

Eind vorig jaar voerde Qiagen al gesprekken met meerdere potentiële kopers, zonder resultaat. Thermo Fisher was toen volgens persbureau Bloomberg ook al in de race en zou bereid zijn geweest €7 mrd te betalen voor Qiagen.

Beleggers krijgen €39 contant voor elk aandeel Qiagen. Dat is een premie van 23% op de slotkoers van maandag. Thermo Fisher neemt ook $1,4 mrd aan schulden over. Daarmee komt de ondernemingswaarde van Qiagen op circa $11,5 mrd (€10,4 mrd).

Qiagen heeft 35 vestigingen, verspreid over 25 landen. In 2019 boekte het biotechnologiebedrijf met wereldwijd 5100 werknemers een omzet van bijna €1,4 mrd.

Overnamepremie niet hoog

De overnamepremie van 23% is niet opvallend hoog. Bij overnames in de farmaceutische industrie worden vaak veel hogere prijzen betaald, zeker voor bedrijven die geneesmiddelen ontwikkelen. Zo betaalde het Amerikaanse farmaconcern Gilead gisteren $4,9 mrd (€4,4 mrd) voor het biotechbedrijf Forty Seven. Dat komt neer op een overnamepremie van 96%. Forty Seven ontwikkelt een immuuntherapie om kanker beter te kunnen bestrijden.

Afhankelijk van de goedkeuring van de aandeelhouders en de autoriteiten verwachten de twee bedrijven dat ze de overname in de eerste helft van 2021 kunnen afronden. Om de overname te financieren heeft Thermo Fisher een overbruggingskrediet gekregen waarvan het de hoogte niet heeft bekendgemaakt. Verder betaalt de Amerikaanse onderneming de overname met eigen contanten en door nieuwe schulden aan te gaan.

Grote acquisitie voor Thermo Fisher

Thermo Fisher realiseerde vorig jaar een omzet van $25 mrd. Een kwart daarvan kwam uit de verkoop van laboratoriumapparatuur en 15% uit materiaal voor diagnostiek. De rest van de omzet kwam uit diensten, andere materialen en zogeheten reagentia; dat zijn chemische stoffen of mengsels die worden gebruikt bij testen of experimenten.

De overname van Qiagen is voor Thermo Fisher de een na grootste acquisitie uit de geschiedenis van het bedrijf. De grootste aankoop dateert van 2014, toen de fabrikant voor laboratoriumapparatuur voor $13,6 mrd Life Technologies Corp overnam.

In 2017 kocht Thermo Fisher ook de medicijnenfabrikant Patheon, waarin het Nederlandse DSM zijn farmaceutische activiteiten had ondergebracht. Thermo Fisher Scientific betaalde toen $7,2 mrd voor Patheon, inclusief de nettoschuld van circa $2 mrd.

Thermo Fischer kocht ook al twee microscopenmakers uit Eindhoven. Twee jaar geleden nam het voor een onbekend bedrag Phenom World over. In 2016 kocht het FEI voor $4,2 mrd.

fd.nl/ondernemen/1336786/amerikanen-n...
Forecast2006
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Mooi bericht Voda,

Meer productie capaciteit voor de vraag naar meer testen.

Gaan we lekker op omhoog vandaag en hoger op naar 17 maart in afwachting op de FDA goedkeuring.

Kind regards,

Forecast.
Forecast2006
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16 maart nieuws Novacyt

Page 1of 2NovacytS.A.("Novacyt"orthe"Company")Coronavirus testupdateInitial orders from Public Health EnglandParis, France and Camberley, UK –16March2020–Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, is pleased to provide an update regarding the novel coronavirus (COVID-19) testdeveloped by Primerdesign, its molecular diagnostics division.Following the completion of Public Health England’s(PHE) formal evaluation of Primerdesign’s COVID-19 test, as announced on 12 March 2020, the government agency has commenced ordering the test.Orders areinitially for eight hospitalsto provide stocks in those locations for four weeks of planned testing. The total value of the initial purchase is approximately £1.0million(€1.1million),which is the single largest order the Company has received to date for its COVID-19test.As of 13 March2020, Primerdesign has sold and received orders for over £3.7 million (€4.3 million)of its CE-Mark and research use only (RUO) COVID-19 tests, whichincludes the order received from PHE. This represents approximately eight months of sales for the division under normal circumstances.This is additional revenue to the core Novacyt business. Graham Mullis, Chief Executive Officer ofNovacyt,commented:“We welcome Public Health England’sdecision to use our COVID-19 test in the UK and I am delighted to seethat Novacyt will now besupporting one of itshome marketsduring these challenging times. The number of countries Novacyt is now supplying with its COVID-19 testhas reached over 60 and we expect this will continue to increase. “The team atNovacytand its key suppliersare workingextremely hard to supportclinicians aroundthe world in the fight against this pandemic and,as a Chief Executive Officer, I am immensely proud of everyone’s commitment.”This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.-End –
voda
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Britse overheid bestelt coronatest van Novacyt

FONDS KOERS VERSCHIL VERSCHIL % BEURS
Novacyt
1,484 0,194 15,04 % Euronext Paris

(ABM FN-Dow Jones) Het Britse Public Health England (PHE) heeft voor acht ziekenhuizen de coronatest van Novacyt besteld. Dit meldde de Franse specialist in klinische diagnoses maandag.

Na voltooiing van de formele evaluatie van de test heeft het uitvoerend agentschap van het Britse Department of Health and Social Care de tests besteld voor acht ziekenhuizen.

De totale waarde van de bestelling bedraagt circa 1 miljoen Britse pond, de grootste order order die het bedrijf tot nu toe heeft ontvangen.

Per 13 maart 2020 stond het aantal bestellingen van de test op meer dan 3,7 miljoen pond, wat onder normale omstandigheden circa acht maanden omzet voor de divisie vertegenwoordigt.

Op 17 februari introduceerde het bedrijf de nieuwe test op de markt, die kan worden gebruikt voor klinische diagnoses van besmetting met het virus en een meer uitgebreide toepassing in laboratoria. Het is een van de eerste tests zijn met een zogeheten CE-Mark-goedkeuring van de Europese Unie en enkele partnerlanden.

Door: ABM Financial News.
info@abmfn.nl
Redactie: +31(0)20 26 28 999

© Copyright ABM Financial News B.V. All rights reserved.
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Paris, France and Camberley, UK –20March2020–Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, is pleased to provide an update regarding the novel coronavirus (COVID-19) testdeveloped by Primerdesign, its molecular diagnostics division based in the UK.As of today, Primerdesign has sold and received orders for over £8.7million (€9.6 million) of its CE-Mark and research use only (RUO) COVID-19 tests.

This represents approximately 18 months of total sales for the division under normal circumstances and already exceeds the total sales achieved by Primerdesign in 2019. All Novacyt staff and the Company’s recently appointed manufacturing partner are working at full capacity to fulfil this demand.The Company has a very strong sales pipeline,which continues to change daily.However, the Company is unable to predict with any certainty the conversion rate of these ongoing enquiries into orders. Notwithstanding this,given the significant level of sales achieved in the past two weeks, the Company confirms it is taking further action to increase its manufacturing capacity.

On 12March,the Company announced its investment plans for raw materials and the appointment of a third-party manufacturer to support demand of approximately 2 million COVID-19 tests per month. Novacyt can confirm that it is making good progress with this supplier and expects the first batches of product to be delivered to customers from this manufacturer in the next week,with output expected to increase significantly by the end of the month. In addition,the Company has purchased additional raw materials so that it is now able to produce more than5 millionCOVID-19 tests and will constantly review this during the next few weeks.

The Company also announces it is in advanced discussions with a second third-party manufacturer,based in the UK,in order to further expand manufacturing capacity. Having three independent manufacturing sites also enables the Company tode-risk its own supplychain in the event that COVID-19disrupts manufacturing operations. Graham Mullis, Chief Executive Officer of Novacyt, commented:“Earlier this month,I reported we were seeing unprecedented interest and demand for our COVID-19 test.The sales and orders we have achieved in a period of just six weeks supports this statement. I reiterate our view that commercial demand forour COVID-19 test will continue for some months to come. Therefore, the additional steps we are taking to meet this demand are essential to support governments and health providers around the world in tackling this virus.”

Kind regards

Forecast
Forecast2006
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Hallo allen,

Vanmorgen op het nieuws: Concurrent Roche kan niet meer leveren.

De productie machine bij Novacyt draait op driedubbele aantallen.

Kind regards,

Forecast
alexnr75
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Correctie:

Roche kan niet genoeg leveren.

Daarnaast zou het kunnen dat het product van Novacyt niet kan worden toegepast op de machines van Roche.
Forecast2006
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30/03/20Posted in Board,
Novacyt Group, NOVAPREP®, Products, Services, Uncategorized

Coronavirus test update, Sales and manufacturing update and COVID-19 test approved in India and Argentina
Forecast2006
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Ministerpresident Rutten in toespraak van 19.00 uur,

We gaan meer testen, naar 16000 testen per dag.

Kind regards,

Forecast.

Forecast2006
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Deze maand komt Novacyt met de jaarcijfers van 2019 met daarin het vooruitzicht 2020.

Je kunt ze maar beter hebben.

Kind regards,

Forecast
voda
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Liquidity Agreement Monthly Update and Total Voting Rights

Paris, France and Camberley, UK – 1 April 2020 - Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces its monthly update in relation to ordinary shares traded under its ongoing liquidity agreement with Invest Securities SA (the “Liquidity Agreement”). The Liquidity Agreement is governed by French law and is further
summarised in the ‘notes for editors’ section below.

During the period from 1 March to 31 March 2020, Invest Securities purchased 5,500 ordinary shares at a maximum price of €2.02 and a minimum price of €0.93 and sold 8,000 ordinary shares at a maximum price of €2.21 and a minimum price of €1.35 under the Liquidity Agreement. The total number of ordinary shares in the Company, which are held in treasury as at close of business on 31 March 2020, is 4,550.

Total Voting Rights
The total number of ordinary shares in the Company is 67,673,567. This figure may be used by shareholders as the denominator for calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, the Company pursuant to Article L. 223-7 of the French Commercial Code and the Company's Articles. The Company is not subject to the disclosure guidance and transparency rules made by the Financial Conduct
Authority under Part VI of FSMA.

For further information, please refer to www.novacyt.com or contact:
Novacyt SA
Graham Mullis, Chief Executive Officer
Anthony Dyer, Chief Financial Officer
+44 (0)1276 600081
SP Angel Corporate Finance LLP (Nominated Adviser and Broker)
Matthew Johnson / Charlie Bouverat (Corporate Finance)
Vadim Alexandre / Rob Rees (Corporate Broking)
+44 (0)20 3470 0470
FTI Consulting (International)
Victoria Foster Mitchell / Mary Whittow
+44 (0)20 3727 1000
victoria.fostermitchell@fticonsulting.com / mary.whittow@fticonsulting.com
FTI Consulting (France)
Arnaud de Cheffontaines
+33 (0)147 03 69 47
arnaud.decheffontaines@fticonsulting.com

novacyt.com/wp-content/uploads/2020/0...
Forecast2006
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Page 1of 2NovacytS.A.("Novacyt"orthe"Company")COVID-19 diagnostic regulatory updateCNR (Institut Pasteur)approvalin FranceMinistry of Health approval in ThailandParis,

France and Camberley, UK –6April 2020 –Novacyt (EURONEXT GROWTH: ALNOV; AIM: NCYT), an international specialist in clinical diagnostics, announces that the CNR (Centre National de Référence des Virus des Infections Respiratoires (dont la grippe))of the Institut Pasteur, an internationally renowned centre for biomedical researchwith a goal of improving public healthin France, has approvedits COVID-19test. The Company’s CE-Marktest isavailable for immediate distribution into the French market.On 2 April2020, Novacyt also received approval for its COVID-19 test from the Ministry of Health in Thailand.Graham Mullis, Chief Executive Officer of Novacyt, commented:“As an Anglo-French company, I am delighted that Novacyt is able to support both of its domestic markets in tackling this pandemic. The Institut Pasteur’s evaluation and approval of our COVID-19 test is an important validation and I am grateful to Atothis,our distribution partner in France,for its efforts in working with the centre.Welook forward to supporting the French authorities in their COVID-19 testing requirements.”The Primerdesign COVID-19 test has received accreditation from a number of leading global regulatory authorities, including Public Health England and the US Food and Drug Administration. In addition to the test currently being approved in the UK, the US, France, India, the Philippines, Argentina and Thailand, itis available in markets which directly accept CE-Mark accreditation without the need for further approval.This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014.
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Vertraagd 6 apr 2020 13:47
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