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Verrelst was compleet verbrand.Aan Moody om de versnelling te bewerkstelligen.Alles op de Amerikaanse markt?De kortste weg naar winstgevendheid?Later Japan?China van de baan?Wat met de Q1 cijfers op 20 april?In Q1 1(!) samenwerking en een FDA approval (die ons reeds 2 jaar beloofd werd).Op 24 april start de nieuwe CEO, toevallig?Hij zal voor een deftige versnelling moeten zorgen.
Op de blog van De Tijd: 11:36 'Nieuwe CEO kan Biocartis op koers zetten naar break-even' KBC Securities verwelkomt de aanstelling van een nieuwe CEO bij Biocartis. Volgens analist Thomas Vranken is Roger Moody de juiste man voor de job. 'Moody brengt meer dan 30 jaar ervaring mee in het opschalen van beursgenoteerde bedrijven', aldus Vranken. 'De aanstelling van een CEO die in de VS is gevestigd, past bovendien bij de plannen van Biocartis om de verkoop van het Idylla-platform in de VS te stimuleren'. Vranken verwacht dat Biocartis uiterlijk in 2025 winstgevend zal worden. 'We kijken uit naar verkoopsgroei in de Amerikaanse markt en aanvullende partnerships op weg naar een break-even'. Het koopadvies blijft gelden met een koersdoel van 1,2 euro, goed voor een quasi-verdubbeling vanaf de huidige stand.
Aandeel staat op ontploffen…mmm…
Misschien eindelijk een ceo die voldoende in het bedrijf gelooft om zelf aandelen in te kopen...
Study validates SkylineDx’s Merlin test can avoid surgery and lower healthcare costs ROTTERDAM (the Netherlands), SAN DIEGO (CA, USA), April 12, 2023: SkylineDx, an innovative diagnostics company focused on research & development of molecular diagnostics for oncology and inflammatory diseases, today announced research demonstrating significant cost-saving potential with use of its Merlin test, which may reduce the rate of unnecessary sentinel lymph node biopsies (SLNB) in SLNB-eligible patients with cutaneous melanoma. The SLNB procedure is currently the standard of care, and the most prognostic tool available for determining the course of treatment for patients with cutaneous melanoma. Yet 80% of SLNB results are negative and non-therapeutic, and according to a recent study published by the International Journal of Dermatology, can add nearly $10,000 to the cost of treatment. The SkylineDx molecular Merlin test helps identify melanoma patients who are at low risk for nodal metastasis, and may subsequently forgo aSLNB procedure. At a Medicare reimbursement rate of $4,600 per test, the Merlin test could significantly reduce the number of unnecessary surgeries, and the overall cost of care for cutaneous melanoma. “These findings support our mission to improve a patient’s quality of life by providing reliable genomic-level insights about their disease,” said Jvalini Dwarkasing, Chief Scientific Officer of SkylineDx. “The Merlin test, when incorporated into the patient’s melanoma journey, will help arm physicians with the information needed to guide the treatment pathway, avoid unnecessary surgery, and reduce overall costs to the healthcare system.” About Merlin The Merlin test, which was developed in collaboration with Mayo Clinic, uses the CP-GEP model, a powerful proprietary algorithm that calculates the risk of metastasis in a patient’s sentinel lymph nodes. The model is able to calculate risk on an individual basis through a combination analysis of 8 genes from the patient’s primary tumor, the tumor thickness and the patient’s age; and has been analytically and clinically validated. The Merlin test is commercially available and Medicare reimbursed as a Laboratory Developed Test serviced from SkylineDx’s CAP/CLIA laboratory in San Diego (CA). More information about Merlin can be found at www.falconprogram.com. About SkylineDx SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient’s response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam. the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego California, USA. To learn more about SkylineDx, please visit www.skylinedx.com. Footnotes Thao et al., Cost evaluation of the Merlin assay for predicting melanoma sentinel lymph node biopsy metastasis. International Journal of Dermatology (2022). doi.org/10.1111/ijd.16515. Hieken et al., Using the Merlin assay for reducing sentinel lymph node biopsy complications in melanoma: a retrospective cohort study. International Journal of Dermatology (2022). doi.org/10.1111/ijd.16056. Agnese et al., Cost-effectiveness of sentinel lymph node biopsy in thin melanomas. Surgery (2023). doi.org/10.1016/S0039-6060(03)00275-7. Bellomo et al., Model combining tumor molecular and clinicopathologic risk factors predicts sentinel lymph node metastasis in primary cutaneous melanoma. JCO Precision Oncology (2020). doi.org/10.1200/PO.19.00206.
Hard to get too excited about the announcement of a new CEO. Moody's track record does not exactly appear stellar. Selling BCART at today's basement prices might enable Verrelst to claim he was not at the helm for the entirety of the company's demise but it does not absolve him from the blame for his numerous misteps and inaction. If Moody is indeed being brought in for his US Market experience, he will have considerable work to do. As BCART has often declared in their presentations, the success of the platform is dependent on the environment and the amount of content available. At present, the non-RUO content is slim and disjointed (MSI and Septicyte). This content is not much to entice a potential lab or hospital to buy into the platform, Fortunately the platform costs are not exorbitant. They may need to convince buyers if they have additional content undergoing FDA review. Also, BCART will need BMS to push the CDx application of MSI. I wish I could get excited about analysts upgrades, but they have missed the mark horribly for so long that they have lost creditability. FL
I thought moodys resume was very underwhelming. Hopefully I'm proven wrong
We gaan hem een kans moeten geven.Veel slechter of de voorbije jaren kan niet meer.De markt denkt er blijkbaar ook zo over.
Deceptie op Deceptie. Awel, in 2 weken 20% erbij.
My question is whether BCART learned any lessons that might allow faster registration approvals with the FDA. The 2 years that the MSI application was under review is nearly twice as long as a typical review. And MSI had a relatively strong head to head testing profile. FL
na 5 jaar 94% eraf ! inderdaad laten we positief blijven
Heb nog 10K stukjes op de plank liggen met een gak van €4,08. Ben bang dat Moody de tent gaat uitverkopen onder één Euro. We zullen het zien.
Die ga je nooit meer terug zien naar mijn gevoel. Meer dan 2 euro zie ik ook niet snel gebeuren
Hopelijk binnenkort eens concreet nieuws , bijv FDA aanvraag van AstraZeneca .., die samenwerking loopt ook alweer een tijdje ( en is vorig jaar nog uitgebreid als ik Biocartis mag geloven).., zodat het stijgende lijntje eens doorgezet kan worden.., mja., mocht de € 1, - grens overwonnen worden, dan komt al snel de € 1,125 in beeld waarbij er weer heeeel veel aandeeltjes bijgedrukt kunnen worden....( converteerbare obligaties )
Bonsjoer, I'm not aware of the EGFR assay being submitted to FDA, yet. The AZN partnership was announced in Jan 2020, the CDx partnership was announced in June 2022 and to my knowledge, no registration application has been submitted, yet. In fact 2 years ago I wrote IR about my concerns that the EGFR T790 mutation amplification curve issue precluded filing any sort of a CDx for Tagrisso. I was told by IR that they were working on it and would have a fix out soon. I have posted about this at least a couple times. If the MSI review timeframe is any indication, then approval of any CDx is a 2025 or beyond event. The lack of urgency under which BCART operates is the major reason why my outlook soured so much. They simply act as if the funding window will always remain open for them. Hopefully, the last round provided a much needed dose of reality that investor patience was at an end. FL
Pré-opening…€0,80…nice…nice…
Leuke winst genomen…thx Biocartis…
nieuwe CEO zal andere prioriteiten hebben dan de vorige. Eentje ervan is dat hij heel goed weet hoe je een dergelijk bedrijf moet verkopen en aan wie ook. Je voelt het aan je kleine teen dat het beweegt. Het strafste was dat 1 dag voor het bekend maken van de aanstelling van de nieuwe CEO er reeds vele aankoop orders geplaatst werden gezien de omzet. Het verbaasd me dat ze dit niet onderzoeken. Biocartis zal verkocht worden aan veel hogere prijzen dan we nu zien.
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