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Abivax

513 Posts
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  3. Bioteg71 3 september 2020 08:23
    Abivax reports long-lasting two-year efficacy and safety data from ABX464 ulcerative colitis Phase 2a maintenance study
    Phase 2a open label maintenance results after second year of treatment confirm good safety profile and durable efficacy of 50mg once-daily oral ABX464
    After the second year of continued treatment, 69% of patients were in clinical remission1 and 94% benefited from a clinical response2
    Readings of the endoscopies were performed centrally by independent reviewers; Median fecal calprotectin (31.6 µg/g) was in the normal range
    Patient enrollment for ongoing Phase 2b ulcerative colitis trial is on track, with 69% (159/232) of patients randomized to date and recruitment expected to be completed by the end of 2020 and expected results in Q2/2021
    Abivax is currently preparing all required steps to advance ABX464 into UC Phase 3
    PARIS, France, September 2, 2020 – 9:00 p.m. (CET) – Abivax (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, today announces two-year Phase 2a maintenance data of ABX464 in ulcerative colitis (UC), showing that 69% of the patients were in clinical remission and 94% benefited from a clinical response. The patients suffering from moderate-to-severe UC were all intolerant and/or refractory to at least one existing treatment prior to entering the ABX464 study. These data confirm good safety and efficacy results of ABX464 during the second year of treatment, which were already observed during the induction and first year of the maintenance study.

    Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, said: “We are very excited about the two-year open label Phase 2a maintenance results, which provide further momentum for our clinical development efforts with ABX464 to address the high unmet medical need in UC. These recent findings reinforce the potential of ABX464 as a well-tolerated and efficacious once-daily oral therapy for patients with moderate-to-severe ulcerative colitis.”

    Out of 32 patients included in the active or placebo arm of the initial induction phase, 22 were enrolled in the 50mg once-daily open label ABX464 Phase 2a maintenance study. 19/22 patients stayed on treatment for 52 weeks and 16/19 patients completed the second year of ABX464 maintenance treatment. Readings for all endoscopies were performed centrally by independent reviewers. The data showed that 11/16 (69%) patients were in clinical remission and 15/16 (94%) benefited from a clinical response. 7/16 (44%) had endoscopic remission consisting of complete disappearance of colon/rectum lesions (endoscopic Mayo score=0). Median fecal calprotectin, the key biological marker of UC disease activity, which was normalized during the first year of treatment, remained at 31.6 µg/g (normal levels are below 50 µg/g).

    ABX464 was safe and well tolerated and there were no serious adverse drug reactions reported. No patients were prematurely discontinued due to adverse event during this second year of ABX464 treatment.

    Prof. Séverine Vermeire, M.D., Ph.D., Head of the IBD Center at the University Hospitals Leuven, Belgium, and principal investigator of the study, said: “The safety and durability of clinical efficacy after two years of continued treatment of UC patients, intolerant or refractory to existing treatments, are very promising. Especially as the central and independent endoscopy readings after two years confirm the good one-year maintenance results, where endoscopies were read locally. We are very motivated to continue enrolling patients in the ongoing ABX464 Phase 2b induction and maintenance study and hope to be able to confirm the findings from the Phase 2a study.”

    Prof. William Sandborn, M.D., Director of the Inflammatory Bowel Disease (IBD) Center at University of California (UC) San Diego Health, and Chief, Division of Gastroenterology at UC San Diego School of Medicine, added: “The two-year Phase 2a maintenance results confirm the potential of ABX464 to become a treatment option for UC patients who do not respond or stop responding to currently available treatments after a certain period of time, including biologics. This debilitating disease greatly affects patients’ quality of life and requires expensive and cumbersome therapies. The innovative mechanism of action of ABX464 and data from this trial represent a promising new potential approach to the treatment of ulcerative colitis that could provide these patients with an easily administered, once-daily oral, long-term effective therapeutic option.”

    Update on Abivax’s Phase 2b induction and maintenance studies in moderate-to-severe UC patients:

    The study is currently ongoing in 15 European countries, Canada and the US, enrollment is on track with 69% (159/232) patients randomized to date in the induction study. Patient recruitment is expected to be completed by the end of this year with first top-level results to be communicated in Q2/2021. Out of 85 patients who completed the induction phase, only one patient did not roll over into the maintenance study, while the remaining 84 patients did. All patients in the maintenance study are receiving daily doses of 50mg oral ABX464, which shows a good safety profile consistent with previous studies. The clinical program in UC is Abivax’s top priority and all necessary steps to further progress into Phase 3 studies are being prepared.

    Update on other ongoing and planned clinical trials with ABX464:

    Enrollment in the Phase 2a trials in rheumatoid arthritis is progressing well, with anticipated completion of recruitment by year-end. The Phase 2b/3 clinical trial in Covid-19 patients has been approved in all participating European countries and Brazil, where recruitment is ongoing and expected to be completed in Q4/2020, subject to the evolution of the pandemic. Following the recommendations of leading KOLs, Abivax is planning to go straight into a pivotal Phase 2b/3 trial for Crohn’s disease, which is expected to start recruiting beginning of 2021.


    ******

    About Abivax
    Abivax, a clinical stage biotechnology company, is mobilizing the body’s natural immune machinery to treat patients with autoimmune diseases, viral infections, and cancer. Abivax is listed on Euronext compartment B (ISIN: FR0012333284 – Mnémo: ABVX). Based in Paris and Montpellier, Abivax has two drug candidates in clinical development, ABX464 to treat severe inflammatory diseases, and ABX196 to treat hepatocellular carcinoma.
    More information on the company is available at www.abivax.com. Follow us on Twitter @ABIVAX_.


    Contacts



    Abivax
    Communications
    Regina Jehle
    regina.jehle@abivax.com
    +33 6 24 50 69 63

  5. Wil Helmus 7 september 2020 08:33
    Van German Biotech via twitter:

    The long term data on ABX464 ( $ABVX ) at UC looks very good. A comparison with Etrasimod ( $ARNA ) on ITT basis shows after 12 months:
    Clinical remission -> 55% ABX464 vs 31% Etrasimod
    Endoscopic improvement -> 73 % ABX464 vs 41 % Etrasimod

    It should be noted that the ABX464 patients were significantly more pre-treated with biologics and that the majority of patients treated with etrasimod received a basic treatment with 5-aminosalicylates in parallel.

    Consequently, ABX464 would have performed even better under comparable conditions.

    I also looked at the long-term data on vedolizumab ( $TAK ).
    In the VISIBLE 1 trial all UC patients who achieved clinical response in the induction phase were treated for one year.

    Of the vedolizumab responders, 46% had clinical remission and 56% had mucosal healing after 1 year. These are clearly lower values than those achieved with ABX464 in the overall collective (responders and non-responders).

    A major problem is that when UC is treated with biologics, their effect decreases significantly over time.

    ABX464 also shows good results here: For the whole collective, 55% (ITT) clinical remission after 1 year (75% on a PP basis) and 50% (ITT) after 2 years (69% PP).

    Clinical response after 2 years ABX464 (68% ITT, 94% PP) is better than after 1 year etrasimod (63%, 79%) despite usually decreasing effects during long-term treatment.

    Overall, the results of ABX464 in UC are convincing. However, they must be confirmed in a larger trial.
  7. grounds for hope ? 28 september 2020 21:11
    ABx464 is een krachtige ontstekingsremmer.

    Après deux ans de traitement continu, 69% des patients ont atteint le stade de rémission
    clinique1 et 94% bénéficient d’une réponse clinique2.

    Weinig volumes, geen koersstijging momenteel. Maar dit is toch een veelbelovend molecule.

    Ik hou mijn positie goed vast
  9. Wil Helmus 30 september 2020 12:53
    UC moet het gaan doen volgens German Biotech:

    1/2
    I wish you all the best, but I don't believe that ABX464 will play a major role in the treatment of #COVID19. For example, the viral load can be lowered much more with monoclonal neutralizing antibodies, the mAbs could be combined with an anti-inflammatory drug as needed.

    2/2
    ABX464 is very promising in the indication UC. In my opinion this is the main reason why $ABVX is an interesting investment.
  10. Derwing 30 september 2020 17:57
    quote:

    Wil Helmus schreef op 30 september 2020 12:53:

    UC moet het gaan doen volgens German Biotech:

    1/2
    I wish you all the best, but I don't believe that ABX464 will play a major role in the treatment of #COVID19. For example, the viral load can be lowered much more with monoclonal neutralizing antibodies, the mAbs could be combined with an anti-inflammatory drug as needed.

    2/2
    ABX464 is very promising in the indication UC. In my opinion this is the main reason why $ABVX is an interesting investment.
    Zo denk ik er ook over hoor, dat feit dat het wat virusremmend is is al lang niet meer zo bijzonder, plasma werkt ook prima daarvoor en er zijn veel betere middelen ondertussen. Het grote geld voor COVID zit nu met name in oplossingen zoals vaccins.

  12. Derwing 18 oktober 2020 15:19
    quote:

    Wil Helmus schreef op 18 oktober 2020 09:45:

    Na Galapagos ook bij Roche tegenvallende UC resultaten:

    Roche writes off ulcerative colitis portion of etrolizumab program, days after dissecting PhIII setback

    endpts.com/roche-writes-off-ulcerativ...
    Ik ben benieuwd of Abivax hierdoor maandag een boost krijgt.
    Ze hebben vorige week wel weer voor een paar maanden extra financiering binnengehaald maar dat heeft weinig met de koers gedaan.
  13. Wil Helmus 29 oktober 2020 10:14
    We are delighted to announce our successful capital increase of EUR 28m that has been subscribed by top-tier U.S. and European biotech investors and which will extend the Company’s cash runway until Q4 2021.
    #capitalincrease #biotech #inflammation
    t.co/e7s34iw37B t.co/EMNggCeFH8
  15. Derwing 1 november 2020 16:51
    quote:

    Wil Helmus schreef op 30 oktober 2020 21:39:

    $ABVX (yesterday):
    "A webcast will be organized for the beginning of the week of November 2, 2020. Details will be communicated in a separate press release."

    This only makes sense if there are important news during the next days.
    Ik ben benieuwd wat Abivax komende maanden gaat brengen.
    Ze hebben net geld opgehaald, dus verwacht nu niet ineens een partnership of overname. Het belangrijke nieuws zou dan moeten gaan over studieresultaten, maar wordt het niet gewoon simpelweg een conference call over de kwartaalcijfers?
  16. Bioteg71 23 december 2020 09:02
    Abivax’s Covid-19 phase 2b/3 miR-AGE trial with ABX464 declared Research National Priority by the French government’s clinical trial council
    Research National Priority has priority for patient enrollment in clinical trials for an accelerated review and approval process with the French regulatory authorities

    Effective Covid-19 treatments very much needed because optimal vaccination coverage of millions of individuals and public acceptance will take time

    ABX464 mechanism of action not expected to be impacted by viral mutations

    Pivotal phase 2b/3 Covid-19 trial results expected in Q2 2021 and ABX464 manufacturing scale-up is ongoing to meet potential demand from commercialization in 2021

    PARIS, December 22, 2020 – 7:30 p.m. (CET) – Abivax (Euronext Paris: FR0012333284 – ABVX), a clinical-stage biotechnology company harnessing the immune system to develop novel treatments for inflammatory diseases, viral diseases and cancer, today announced that the Company’s ongoing ABX464 phase 2b/3 trial in high-risk Covid-19 patients (miR-AGE) has been declared a “Research National Priority” by the French government steering committee for therapeutic clinical trials and other research (CAPNET). This committee, advised by the REACTing Scientific Council, has been created by the French government to identify the most promising and impactful Covid-19 clinical trials in order to help investigators focus their patient recruitment and to foster the swift availability of high-level study results. Clinical trials declared Research National Priority and their sponsors have access to an accelerated regulatory review and approval process conducted by the French regulatory authorities (ANSM) and the French Ethics committee (CPP). The Research National Priority designation also incentivizes clinical investigators to prioritize enrollment of their patients in these clinical trials and may provide institutional financing of these clinical studies.

    Philippe Pouletty, M.D., Chairman of the Board of Abivax and CEO of Truffle Capital, said: “We are proud to be part of the national and international efforts to fight Covid-19 and that the French government's Covid-19 scientific council decided to designate the miR-AGE trial with ABX464 drug candidate a Research National Priority, given ABX464 promising characteristics for early treatment of infected patients. Abivax is devoting significant efforts to this major international clinical trial and simultaneously accelerating ABX464 manufacturing scale-up for potential 2021 commercialization. The strong support of Bpifrance and GCI has been critical in providing the necessary resources to our team and partners. We cannot predict the efficacy of ABX464 in Covid-19 patients before miR-AGE trial results are available. However, given the major impact of Covid-19 pandemic, it is our duty to anticipate the commercial availability of ABX464 in order to be ready to obtain a marketing authorization and launch the product in 2021, should the miR-AGE trial provide positive results.”

    Abivax’s lead drug-candidate ABX464 has shown in clinical and preclinical studies that it may have a potentially beneficial triple effect for the treatment of elderly and high-risk Covid-19 patients, including an antiviral and anti-inflammatory effect as well as tissue repair properties. With its unique molecular mechanism of action (upregulation of miR124), and convenient oral dosing, ABX464 can be used in patients upon diagnosis and has the potential to prevent and treat cytokine storm and hyper-inflammation, which can lead to acute respiratory distress syndrome (ARDS) and death of Covid-19 patients. Should the results from the ongoing phase 2b/3 Covid-19 study expected for Q2 2021, be positive, Abivax will immediately seek accelerated marketing approvals in the major markets in 2021, and it is preparing for manufacturing scale-up and potential commercialization of ABX464.

    ABX464 is mainly developed to treat patients with chronic inflammatory diseases and is currently in clinical testing in a phase 2b study in ulcerative colitis (UC), a phase 2a study in rheumatoid arthritis (RA) and a pivotal phase 2b/3 trial in Crohn’s disease will commence in 2021. Topline results of the ongoing trials in UC and RA are expected in Q2 2021. So far, over 700 patients have been treated with ABX464 showing a good safety and tolerability profile. Some patients have been on daily treatment with ABX464 for over three years in the ongoing phase 2a open label extensions study in UC, with promising long-term efficacy results after 2 years of continued treatment. The Company is currently preparing to move its clinical trial program with ABX464 in UC into a pivotal phase 3.

    Prof. Hartmut J. Ehrlich, M.D., CEO of Abivax, added: “Despite the recent approvals for Covid-19 vaccines, there are still many unknowns and effective treatments for Covid-19 infection are needed more than ever. In addition to the logistical challenges in vaccinating billions of people, vaccines are currently not mandatory and public acceptance of vaccination may take time. So effective treatment options for infected patients are highly desirable. In addition, the duration of vaccine protection is still unknown and mutations may emerge – this means we still urgently need to decrease the likelihood of evolution towards severe life-threatening disease in Covid-19 infected patients. As miR-AGE is now a Research National Priority, we hope that the French study centers will be able to recruit more high-risk patients to catch up with other European and Latin American countries. These patients will then be able to potentially benefit from ABX464’s triple effect, along with its convenient and easy oral administration, which also may avoid the need to be hospitalized and ease the burden on our healthcare systems.”

    About Abivax (www.abivax.com)
    Abivax, a clinical stage biotechnology company, is mobilizing the body’s natural immune machinery to treat patients with chronic inflammatory diseases, viral infections, and cancer. Abivax is listed on Euronext compartment C (ISIN: FR0012333284 – Mnémo: ABVX). Based in Paris and Montpellier, Abivax has two drug candidates in clinical development, ABX464 to treat severe inflammatory diseases, and ABX196 to treat hepatocellular carcinoma. More information on the company is available at www.abivax.com. Follow us on Twitter @ABIVAX_.

    Contacts



    Abivax
    Communications
    Regina Jehle
    regina.jehle@abivax.com
    +33 6 24 50 69 63



    Investors
    LifeSci Advisors
    Chris Maggos
    chris@lifesciadvisors.com
    +41 79 367 6254



    Press Relations & Investors Europe
    MC Services AG
    Anne Hennecke
    anne.hennecke@mc-services.eu
    +49 211 529 252 22



    Public Relations France
    Actifin
    Ghislaine Gasparetto
    ggasparetto@actifin.fr
    +33 6 21 10 49 24



    Public Relations France
    DGM Conseil
    Thomas Roborel de Climens
    thomasdeclimens@dgm-conseil.fr
    +33 6 14 50 15 84



    Public Relations USA
    Rooney Partners LLC
    Marion Janic
    mjanic@rooneyco.com
    +1 212 223 4017



  19. Wil Helmus 23 december 2020 11:23
    quote:

    Bioteg71 schreef op 23 december 2020 10:46:

    Nog steeds geen opening....io nu telkens tussen 35 en 40.

    Zijn er nog mensen die Abivax in porto hebben, of inmiddels allemaal uitgestapt?
    Gefeliciteerd, mooie stijging vandaag. Ik ben al een tijdje geleden uitgestapt. Zag elders mooiere kansen. Het plan was om in Q2 2021 weer in stappen aangezien dan fase 2b in UC resultaten bekend gemaakt worden. Ik had om eerlijk te zijn niet zoveel vertrouwen in hun covid trial.
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