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Flatlander
0
El Torro

While you mention that the overall market conditions are deteriorating, the specific market factors affecting BCART are actually quite positive. I'm in a wait and see mode whether they can can deliver on the registration approvals, new assays and start to show sustained margin improvement. I suspect we will get a meaningful update on the state of the business in Asia in November. This will likely include more info on ML3,

FL
ElTorro
0
Hi FL,
You are right, I was referring to other conditions than you were. I just hope that these conditions (increasing inflation, fuel prices going sky high, possible interest raise, US vs China, etc) will not infect the biotech market also. On the other hand we could be talking different within a few weeks.
We have been waiting on approvals for a long time now, I really would like to see them deliver on that area.
Flatlander
0
El Torro

The Septicyte approval is languishing a few months longer than what appears typical. However, we have no knowledge whether they have amended their application by providing any of the COVID data they have generated. The basic question whether Septicyte Rapid is equivalent to the already approved Septicyte Lab is a no-brainer.

I feel that BCART invested heavily to build out capabilities in the US before they had IVD approvals to allow greater sales. Hopefully we soon get the benefit of the sales team and the BMS partnership.

FL
voda
1
PERSBERICHT: Persbericht Biocartis Group NV: Openbaarmaking van een transparantiekennisgeving
PERSBERICHT: GEREGLEMENTEERDE INFORMATIE

12 oktober 2021, 07:00 CEST

Openbaarmaking van een transparantiekennisgeving

Mechelen, België, 12 oktober 2021 -- Biocartis Group NV (de 'Vennootschap' of 'Biocartis'), een innovatief bedrijf in de moleculaire diagnostiek (Euronext Brussels: BCART), kondigt vandaag aan, overeenkomstig artikel 14, lid 1 van de Belgische Wet van 2 mei 2007 op de openbaarmaking van belangrijke deelnemingen in emittenten waarvan aandelen zijn toegelaten tot de verhandeling op een gereglementeerde markt (de 'Belgische Transparantiewet'), dat zij op 11 oktober 2021 een transparantiekennisgeving gedateerd 11 oktober 2021 (de 'Kennisgeving') heeft ontvangen waaruit blijkt dat de deelneming van Credit Suisse Fund Management S.A., onderdeel van Credit Suisse Group AG, op 5 oktober 2021 de kennisgevingsdrempel van 3% heeft overschreden tot 3,08%. De Credit Suisse Group AG houdt nu in totaal 3,24% van de stemrechten in Biocartis, oftewel een stijging van 0,08% in vergelijking met de vorige transparantiekennisgeving www.globenewswire.com/Tracker?data=5W... .

De Kennisgeving bevat de volgende informatie:

-- Reden van de Kennisgeving: Verwerving of overdracht van
stemrechtverlenende effecten of stemrechten.

-- Kennisgeving door: Een moederonderneming of een controlerende persoon.

-- Kennisgevingsplichtige persoon: Credit Suisse Group AG, Paradeplatz 8,
CH-8001 Zürich, Zwitserland.

-- Transactiedatum: 5 oktober 2021.

-- Overschreden drempel: 3%.

-- Noemer: 57.545.663.

-- Details van de Notificatie: Credit Suisse Group AG houdt nu in totaal
1.863.307 stemrechten.

-- Volledige keten van gecontroleerde ondernemingen via dewelke de
deelneming daadwerkelijk wordt gehouden: Credit Suisse Group AG, Credit
Suisse AG, Credit Suisse AG, Dublin Branch / Credit Suisse Group AG,
Credit Suisse AG, Credit Suisse Asset Management International Holding
Ltd., Credit Suisse Asset Management & Investor Service (Schweiz) Holding
AG, Credit Suisse Fund Management S.A. / Credit Suisse Group AG, Credit
Suisse AG, Credit Suisse International.
De Kennisgeving is hier www.globenewswire.com/Tracker?data=Na... ter beschikking op de website van de Vennootschap.

Krachtens de Belgische Transparantiewet en de statuten van de Vennootschap is een kennisgeving aan de Vennootschap en aan de Belgische Autoriteit voor Financiële Diensten en Markten ('FSMA') vereist door alle natuurlijke personen en rechtspersonen, telkens wanneer het percentage van stemrechten in de Vennootschap gehouden door zulke personen de drempel van 3%, 5%, 10%, en ieder verder veelvoud van 5%, van het totale aantal stemrechten in de Vennootschap bereikt, overschrijdt of onderschrijdt.

----- EINDE ----

Meer informatie:

Renate Degrave

Hoofd Corporate Communications & Investor Relations Biocartis

e-mail rdegrave@biocartis.comhttps://www.globenewswire.com/Tracker?data=2bGnd1iXa6PSLPxMK8YmNzKsoJY97ukD3NwAnMVE0Xhnod38zKGkFrDDfSlKiyMX7NaiNIBIPjgeM42spf1C6zW4IsAympwpa8crJPVgskE=

tel +32 15 631 729

gsm +32 471 53 60 64
ElTorro
0
Vreemde koersbewegingen deze week, alsof er iets op til is. Kwartaal cijfers zijn nochtans niet voor meteen.
CGCDLR
0
ElTorro
0
Dat zou pas goed nieuws zijn en daar wachten we inderdaad wel al een tijdje op.
+ goeie kwartaal cijfers en vooruitzichten = we zijn eindelijk vertrokken :-)
OzDx
0
Many jobs advertised in the last few weeks. Ramping up staffing due to high demand? Also see they are advertising for a contract analyst based in the US.
Flatlander
2
www.med-technews.com/medtech-insights...

Maybe Immunexpress is finally getting close on the FDA approval. This interview seems to infer a more imminent US approval and global rollout.

FL
ElTorro
0
Hi FL,
Thanks for the post.
I read they state "once we receive FDA clearance", they don't state when we can expect this to happen. It would help if we could get the clearance this year.. so let's remain hopeful.
Q3 numbers are within 2 weeks, so maybe in the line of their PR strategy they will announce some other positive news.
Flatlander
0
Hi El Torro,
The whole ImmunExpress interview looked like plant questions that Rollie could spin to into an introduction narrative. I expect that thi8s was done as more of a raise awareness thing rather than a substantive dive. One of his previous interviews indicated he anticipated approval before year end. We are running out of year, so hopefully the approval is immanent.

Given the fire shutdown, we all have next to no expectations for the 3rd qtr numbers. Hopefully, they have some good PRs to brighten the day. I'm really looking for an answer as to how they will revamp the EGFR assay to correct the faulty T790 mutation amplification curve problem. This is the key to the AZN Tagrisso CDx. I re-read the September release and was disappointed that they were delaying the the timeframe for the BRAF-EGFR assay. This was supposed to include the changes to correct the T790 issue. A major publication came out in the past couple months and cast doubt on the use of Idylla for EGFR resistance mutation monitoring. They like the fast TAT but indicate that the T790 issue will limit the use of the Idylla assay, They need to share the plan for correcting this issue. It really needs to be done before the China registration since EGFR mutations are much more common in Asians. I've asked Renate about this in the past and was told it would be addressed in the next assay release.

Perhaps the assay correction is underway but they have not shared it with investors. I hope that is the case.

FL
ElTorro
0
Thanks for sharing FL, looks indeed they are expecting FDA news in the near future.
CGCDLR
0
FDA news,Immunexpress/Biocartis = KO Biocartis.De koersevolutie de voorbije weken/maanden spreekt boekdelen.De markt wacht,er is momenteel geen ernstige handel mogelijk in Biocartis.
Stockbrood
0
Heard today that the level of covid testing has never been higher here in belgium. Labs cannot follow the work, and test results have never had a longer leadtime untill they reach the patient allthough not comparable to standard PCR testing, BCART SARS-CoV-2 test must be a well sold assay... now and in the near future. BCART already mentioned that as long as they have a good selling covid test, cartridge commercial result is good. Longer leadtime for test result will probably push even harder towards fast result on idylla.

I'm getting quite confident on good results, as long as they do not suffer a reagent shortage, but I have not heard anything on that since start of ML2. If FDA approval can come before end of the year, we can have a turbo on sales by new year.

Anyone else heard something on reagent shortages?

Stockbrood
Flatlander
0
Stockbrood
The Idylla, SARS-CoV-2 assay is a PCR test in the same way the Cepheid GeneXpert cartridge test is also a PCR. Idylla for some reason takes 30 mins longer but I believe they are comparable. During the fire ML2 hiatus this test was not prioritized. Fortunately, I beleive that corresponded to a lower demand period. Hopefully, they are not rationing any of the assays due to reagent availability.

FL
Stockbrood
1
Flat, i was comparing to lab testing PCR, not automated cartridge testing.

My point was testing volume has never been higher...
I heard chief of laboratory Medina talking about 24/7 testing. They are at max capacity. They cannot get the result to the patient anymore in less than 24h...

All these triggers should mean demand for the SARS-CoV-2 is high...

With what we know now, I think testing for covid will be with us much longer than we think.

Stockbrood
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