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Nordic Nanovector - Fundamentale forhold 2019 (NANO)

Nordic Nanovector skal i resultatilden onsdag, og selv om det ikke er ventet noen omsetning, og et negativt brutto driftsresultat (EBITDA) på 85 millioner kroner, er det spenning knyttet til rapporten skriver DNB Markets.

Meglerhuset skriver at det blir første anledning for selskapet å gi investorene en oppdatering på tidsplanen knyttet til utviklingen av Belatulin, der selskapet tar sikte på å foreta første dosering av en pasient i løpet av andre kvartal. I tillegg er det ventet at markedet blir oppdatert på antall land som har godkjent gjennomføring av PARADIGME-studien og samtidig totalt antall klinikker som er godkjent for rekruttering av pasienter til studien.

– Det er i første rekke tempoet i og resultatene fra utviklingsarbeidet som er avgjørende. I vårt basisscenario legger vi til grunn at selskapet selv tar produktet helt frem lansering, og at dette vil kunne skje i 2021, skriver DNB Markets, som har en kjøpsanbefaling og et tolv måneders kursmål på 110 kroner per aksje.

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Vi vet alle hva overskriften på Hegnar blir.

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Flyr høyere og lengre dess lavere volum, om det korreleres mot flyvekurven.

Belatulin?

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Rykende fersk. Ryktes NANO har omtale

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Finnes det en sjanse for at REK-godkjenningen for PARADIGME ikke går gjennom med samme begrunnelse man fikk for ARCHER-1? Dvs. språk og prosenter?

Vil tro det er mye copypaste ute og går mellom de to.

Nja, det kan jo hende, men jeg tror ikke det.

ARCHER-1 er jo et nytt studie og fase Ib. De ville jo både ha rettskriving og data på bieffekter, noe som allerede foreligger for PARADIGME. Tror også at copypast blir større innad fra faseI/II til PARADIGME, og det har jo allrede vært igjennom mølla.

On a different note: Det er gøy når det går veien! :smile:
image

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Er Einarsson ekstatisk over at det var så lite som manglet eller er han fokusert på at REK er vanskelige?

Omtaler det som overraskende. Men virker tålmodig, fremmer også røde dager i mai som årsak. Akkurat begynt å høre selv.

Innlegg av: karlman (29.05.18 14:38 ), lest 2 ganger
Ticker: NANO
NANO:LYMRIT-37-01(PARADIGME),10 land åpen for rekruttering
Da er det 10 land åpen for rekruttering nå (innom Europa).

Trial protocol:
SE (Ongoing)
GB (Ongoing)
IT (Ongoing)
CZ (Ongoing)
AT (Ongoing)
ES (Ongoing)
HR (Ongoing)
HU (Ongoing)
IE (Ongoing)
FI (Ongoing)

Ref:
https://www.clinicaltrialsregister.eu/ctr-search/search?query=+LYMRIT-37-01

Husk også:

As of 5 April 2018, PARADIGME was
open for enrolment in 13 clinical sites in 6 countries.

Snart Norge.


Snappet opp på HO og deler her.

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Italia med Bologna evt. Firenze som har kommet om bord?
Edit: Ser det var Finland ja. Noen grunn til at ikke IT står som recruiting på CT gov?

Finland inne som land nr 10. Det ramler inn land, litt etter litt, step by step. Løser seg nok til slutt

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Nordic Nanovector Announces PARADIGME Trial Approved to Start in Norway

 

Oslo, Norway, 29 May 2018

Nordic Nanovector ASA (OSE: NANO) announces that its pivotal PARADIGME Phase 2b trial with Betalutin® (177Lu-satetraxetan-lilotomab) in third-line (3L) follicular lymphoma (FL) patients has been approved by the Regional Committees for Medical and Health Research Ethics (REK) in Norway. Nordic Nanovector has now received all necessary approvals to begin PARADIGME in Norway and will commence start-up activities with the selected clinical sites immediately with the intention of recruiting patients into the study as soon as possible.

PARADIGME is a global, randomised Phase 2b clinical trial comparing two promising Betalutin® dosing regimens in patients with third-line follicular lymphoma who are refractory to anti-CD20 immunotherapy (including rituximab), a population with a high unmet medical need. The trial will enrol 130 patients at 80-85 sites in approximately 20 countries. The first patient is expected to be dosed in the first half of 2018 and the data read-out is targeted to the first half of 2020.

-End-

For further information, please contact:

IR enquiries Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com

International Media Enquiries
Mark Swallow/David Dible/Isabelle Andrews (Citigate Dewe Rogerson)
Tel: +44 207 638 9571
Email: nordicnanovector@citigatedewerogerson.com

About Nordic Nanovector
Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for haematological cancers.
Nordic Nanovector’s lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin’s lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 20 billion by 2024. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.
Further information about the Company can be found at www.nordicnanovector.com

 

Ekstern link: http://news.cision.com/nordic-nanovector/r/nordic-nanovector-announces-paradigme-trial-approved-to-start-in-norway,c2534330

Nyheten er levert av Cision.

http://www.netfonds.no/quotes/release.php?id=20180529.Cision.20180529:BIT:9930:0

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Nordic Nanovector Announces PARADIGME Trial Approved to Start in Norway

Oslo, Norway, 29 May 2018

Nordic Nanovector ASA (OSE: NANO) announces that its pivotal PARADIGME Phase 2b
trial with Betalutin® (177Lu-satetraxetan-lilotomab) in third-line (3L)
follicular lymphoma (FL) patients has been approved by the Regional Committees
for Medical and Health Research Ethics (REK) in Norway. Nordic Nanovector has
now received all necessary approvals to begin PARADIGME in Norway and will
commence start-up activities with the selected clinical sites immediately with
the intention of recruiting patients into the study as soon as possible.

PARADIGME is a global, randomised Phase 2b clinical trial comparing two
promising Betalutin® dosing regimens in patients with third-line follicular
lymphoma who are refractory to anti-CD20 immunotherapy (including rituximab), a
population with a high unmet medical need. The trial will enrol 130 patients at
80-85 sites in approximately 20 countries. The first patient is expected to be
dosed in the first half of 2018 and the data read-out is targeted to the first
half of 2020.

-End-

For further information, please contact:

IR enquiries Malene Brondberg, VP Investor Relations and Corporate
Communications
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com

International Media Enquiries
Mark Swallow/David Dible/Isabelle Andrews (Citigate Dewe Rogerson)
Tel: +44 207 638 9571
Email: nordicnanovector@citigatedewerogerson.com

About Nordic Nanovector
Nordic Nanovector is committed to develop and deliver innovative therapies to
patients to address major unmet medical needs and advance cancer care. The
Company aspires to become a leader in the development of targeted therapies for
haematological cancers.
Nordic Nanovector’s lead clinical-stage candidate is Betalutin®, a novel CD37
-targeting antibody-radionuclide-conjugate designed to advance the treatment of
non-Hodgkin’s lymphoma (NHL). NHL is an indication with substantial unmet
medical need, representing a growing market forecast to be worth nearly USD 20
billion by 2024. Nordic Nanovector intends to retain marketing rights and to
actively participate in the commercialisation of Betalutin® in core markets.
Further information about the Company can be found at www.nordicnanovector.

Ekstern link: http://www.newsweb.no/index.jsp?messageId=452436

Nyheten er levert av OBI.

http://www.netfonds.no/quotes/release.php?id=20180529.OBI.20180529S80

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here we go boys

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Wow :smiley:

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WEEEEEEEEE! :smiley:

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Helt perfekt! Fint å få denne før generalforsamlingen

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Takk og pris…

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