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Home  /  Forum  /  BioPharma  /  Heeft CytoDyn het ultieme anti-HIV-middel??

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Heeft CytoDyn het ultieme anti-HIV-middel??

1.071 Posts
Pagina: «« 1 ... 29 30 31 32 33 ... 54 »» | Laatste | Omlaag ↓
  1. forum rang 6 MisterBlues 22 juli 2020 08:48
    Ik ben blij met de veiligheidsdata: deze zijn gegeven in samenhang met deze ziekte en dat is zeker van belang en ook nieuw.

    Neemt niet weg dat toch telkens weer iets anders geschiedt dan verwacht: uitstel, onvolledig, niet helemaal, herziening etc. Het blijft een bumpy road.

    Wat zou OTC bijvoorbeeld kunnen doen?
  2. forum rang 6 MisterBlues 22 juli 2020 21:23
    Zeer recente samenvatting stand van zaken Cydy

    This is rough recap:

    1) Increase A/S to 800M
    a. Approved by over 65%
    2) Adjournment
    a. Approved by over 67%
    ++++**************************************
    NP:

    CD10 (M2M)
    Unblinded data
    Announced yesterday re: data re: safety
    Will be announcing efficacy as soon as all end-point analysis is completed

    Re: Safety
    If both drug and placebo have same SAEs, then you have a safe drug
    There were almost 3x SAE’s in placebo vs. LERO arm
    64% reduction of SAE when taking LERO vs. placebo
    Only drug in world that can claim this

    JL says this should be the efficacy in this trial

    SK:
    IL-6 inhibitors were worse than placebo
    64% reduction in SAE’s is remarkable
    Also think it bodes well for oncology indication

    NP:
    Will complete analysis within a few days
    Will submit full package to FDA
    Could be a few weeks away from approval

    CD12
    Process of approval could be even easier
    FDA has agreed that study could lead to approval
    DSMC – will look at 1st 100 pts
    This is not an interim analysis; it is just a look at safety

    Now have 153pts enrolled
    Close to 195, which is the interim analysis milestone

    3.1B in last 7mths, 930M shares have been traded this year
    +++++*****************************************
    Cancer
    Planning to meet with FDA in September for BTD
    Believe will have enough data for BTD
    For 23 different cancers

    6 pts in basket trial
    5 pts pending

    15 enrolled in tNBC
    12 pending

    SK:
    Safety in COVID will migrate to cancer trial as well
    Describes MOA
    +++++*************************************
    HIV BLA submission
    GSK, ViiV – spend $400M on injectables
    IZ – had PDUFA date, then 6mths delay due to mfg, long list of items to correct

    We don’t have issues with mfg
    Believe we can resolve clinical issues

    Requesting Type A meeting, hopefully next week
    +++++*********************************

    Advisory Board
    SK:
    Gero Kuter, 1st dr to functionally cure HIV, Timothy Brown

    Hope Rugo, Prof. UCSF, Breast Cancer dept.

    Luish, Cornell, Infectious Diseases, Al

    MD Anderson, further indications in oncology

    Dr. Sacha

    Pulmonary and lung transplant
    Dr. in NASH

    Will announce the others in the coming weeks.
    +++++*****************************************
    Blames former team (of which he was a key member) about past dilution

    Have 18M A/S shares
    8M are in escrow b/c of lawsuit from former BOD

    Plan to use new A/S very carefully

    Warrant exercise this year almost $48M

    $50M worth of warrants out there, 78M warrant shares out there
    +++++**********************************************
    Uplisting
    MM:
    Nasdaq
    5-6 week process
    Last week was week 1
    Now in week 2
    Next week expect to receive comment letter, CYDY will respond quickly
    Week 5 is about mid August
    Week 6 is third week in August
    Filing 10k is due not later than 8/14 – goal is to file early

    MM thinks we will get uplisted in 3-4 weeks.
    +++++*******************************************
    Q&A

    1,300 persons today online

    Q: CD12 differences to CD10
    A:
    CD10 has many different EPs
    Unmet medical need (particularly in a pandemic) can mean no need for P3

    CD12 is P3 approval
    Number of mortalities is PE
    Many SAEs in this trial (= many deaths)
    DSMC will see safety during safety analysis
    Interim analysis will provide efficacy analysis
  3. forum rang 6 MisterBlues 23 juli 2020 09:35
    Aanwijzing over omvangrijke berekening M2M (en S)

    Lets put it that way.

    1. Study: 83 patients.
    2. Time Frame: days: 1st, 3rd, 7th and 14th.
    3. 7 clinical parameters was measured on days; 1st, 3rd, 7th and 14th, means 28 parameters / patient , means : 2.324 parameters total ( 83 x 28)
    4. Oxygen saturation on day: 1st, 3rd, 7th and 14th, means 4 parameters / patient, means 332 parameters total (83 x 4)
    5. Chest radiograph or CT Scan on day 1st and 14th: means 2 parameters / patient, means 166 parameters total (83 x 2)
    6. Blood work on days1st, 3rd, 7th and 14th. Serum cytokine, chemokine, CCR5 receptor occupancy level, CD3+, CD4+, CD8+ levels, ?viral load?, basic blood work, liver, pancreas, kidney…I guess 80 blood parameters per Patient on days 1,3,7,14, that means 320 parameters / patient, means 26560 parameters total ( 83 x 320).
    7. 2.324 + 332 + 166 + 26.560 = 29.382 parameters + many others that I do not know about …lets say 5.000 additional parameters = 28.718 + 5.000 = 34.382 parameters in total
    8. I guess most data manually typed in computer + 3 x check/corrections + radiology analysis + statistics + discussions + 2nd opinions

    Summary: It is impossible to completely unblind the study over the weekend. I love NP and he is an amazing, extremely honest and very optimistic engineer. In reality some things are taking longer as he thinks and we have to accept it. If Amarex would release the data (34.382 parameters + 3 x check/corrections = 103.146 parameters live seen by human being) this week….that would be extraordinary amazing deal..

    He said and he knows to unblind this kind of study takes 4-6 weeks…and that is the reality. Putting an extraordinary effort, over hours, now after today’s dilution he does not have to deal with financial shortness and can easily pay for an extraordinary fast job to Amarex.

    Just be patient, do not blame NP for his optimistic way of thinking and be prepared for week 27-31 of July or 3-7 of August for the complete data release.

    Same with the 195 patients study. There might be 80.776 parameters to analyze. Some survival data of course can be presented in few days, but for the whole study be prepared for September.

    Do not think everything is computerized.. it is not IRA!!!
  4. evr68@hotmail.com 23 juli 2020 14:04
    quote:

    DeZwarteRidder schreef op 17 februari 2017 08:24:

    De market cap van CytoDyn is slechts ca 117 miljoen.
    En de koers staat nu op ca 77 cent.
    Gilead zou weleens belangstelling kunnen hebben.
    In 2017 nog rond de 150 miljoen aandelen?
    Ik lees nu in het bericht van MB een dilution naar 800 miljoen aandelen?

  7. forum rang 6 MisterBlues 23 juli 2020 15:22
    quote:

    evr68@hotmail.com schreef op 23 juli 2020 14:08:

    Dankje MB voor je updates!
    Hoe kijk jij tegen de nieuwe beschikbare informatie aan?
    Eerder postte je , dat je na goede test resultaten misschien wilde verkopen?
    Welke post was dat?

    Ik wilde na mindere resultaten M2M of (straks) S minder exposure, dus halveren of iets dergelijks. Ik zit er echter nog steeds vol in.

    Ik voel me een beetje aan het lijntje gehouden door Cydy maar telkens kom ik geruststellingen tegen.

    Ik wacht nog steeds op gecompileerde gegevens.

    Van de hoeveelheid uitstaande aandelen (dillution) weet ik weinig...
  8. [verwijderd] 23 juli 2020 19:14
    North Texans to Be Part of More COVID-19 Clinical Trials

    The next phase of one investigational COVID-19 treatment may impact North Texans who are critically ill

    Published July 21, 2020 • Updated on July 21, 2020 at 10:53 pm

    Scientists are making headway in the hunt for COVID-19 treatments and vaccines and North Texans are being asked to be a part of it.

    Baylor University Medical Center will be a clinical testing site for CytoDyn's investigational drug Leronlimab, which has been used in a number of patients with COVID-19 as part of two clinical trial applications that have been fast-tracked by the FDA.

    Leronlimab is an experimental treatment for HIV infections but is thought to reduce the amount of inflammation in the lungs caused by the coronavirus, so it may help with breathing problems in COVID-19 patients.

    "We have over 1,100 patients' safety data that shows that we have hardly any serious adverse events," CytoDyn CEO Dr. Nader Pourhassan said.

    Tests will continue to measure efficacy.

    The two-time injectable, according to doctors at Baylor Scott & White, will be given to severely or critically-ill patients who agree to the treatment.

    "What we try to do with this medication like we do with many other medications that we are trying, is to decrease the swelling or inflammation that happens in the lungs," said Dr. Uriel Sandkovsky, principal investigator and Baylor University Medical Center's Infectious Disease.

    Leronlimab is just one of 450 potential therapeutic candidates under investigation, according to Market Report.

    www.nbcdfw.com/news/coronavirus/north...
  9. forum rang 6 MisterBlues 24 juli 2020 08:33
    Hier enkele alinea's uit de transcript van de afgelopen special meeting n.a.v. M2M / CD-10

    De manier waarop ze het spelen verraadt in mijn ogen dat de werkzaamheid in de leronlimab-groep best wel eens bescheiden zou kunnen zijn t.o.v. de placebogroep. Dat is ook moeilijk aan te tonen, daar bijna alle mensen genezen. Ik denk dat ze bang waren voor een koersval na een snelle voorlopige bekendmaking van de werkzaamheid - wat de uplisting geen goed doet. Het is immers toch niet zo moeilijk om op te hoesten hoe deze 2 groepen hebben gescoord t.o.v. elkaar. Die Nader is ook gewoon een zeer gewiekste zakenman.
    (Speculaties van mijn kant.)

    So allow me to update you in regard to recent activities. First, and most important, two COVID-19 trials. We start with CD-10, the mild and moderate population. As we all know, we have unblinded the data on our Phase 2 COVID-19 mild to moderate population as Cytodyn announced yesterday the data in regard to the safety of the trials, and will be announcing the efficacy as soon as the statistical analysis of all the exploratory endpoints are evaluated.

    So in regard to yesterday’s news about the safety of Leronlimab in COVID-19 trials: Usually in any clinical trial if the final result demonstrates that the two arms of the study, the placebo and the drug, have the same number of serious adverse events, same number, then you have a fantastic result in regards to how safe the drug is. However, we already know Leronlimab’s safety with hardly any SAEs in over 900 patients and so forth, right?

    10
    So what is the significance of having almost 3 times more SAE’s in placebo as compared to Leronlimab arm in this study? Leronlimab is probably the only drug in the world right now that just announced that taking Leronlimab for mild to moderate COVID-19 can lower the risk of having an SAE that could be life-threatening by 64%. We believe this is amazing achievement.

    In this population of mild to moderate COVID-19, almost all patients recover fine. Therefore the most urgent matter would be how many life-threatening adverse events you could potentially have that would make your life miserable while you recover, right? Leronlimab demonstrated in CD-10 study that it can lower than possibility by 64%. In the words of Dr. Jay Lalezari, this should be the efficacy for this population.
  10. [verwijderd] 24 juli 2020 08:45
    quote:

    MisterBlues schreef op 24 juli 2020 08:33:

    De manier waarop ze het spelen verraadt in mijn ogen dat de werkzaamheid in de leronlimab-groep best wel eens bescheiden zou kunnen zijn t.o.v. de placebogroep. Dat is ook moeilijk aan te tonen, daar bijna alle mensen genezen. Ik denk dat ze bang waren voor een koersval na een snelle voorlopige bekendmaking van de werkzaamheid - wat de uplisting geen goed doet. Het is immers toch niet zo moeilijk om op te hoesten hoe deze 2 groepen hebben gescoord t.o.v. elkaar. Die Nader is ook gewoon een zeer gewiekste zakenman.
    100% mee oneens, de hoeveelheid data kan eenvoudigweg niet in een weekend worden verwerkt. En ik denk dat de werkzaamheid geweldig zal zijn.

    Ook het verplegend personeel weet precies wie er Leronlimab krijgt. Een ietwat ouder filmpje, volgens mij hier nog niet geplaatst. Na een lange inleiding over hoe zwaar ze het had gaat ze rond de 13:00 over Leronlimab praten.

    www.youtube.com/watch?v=k7O9c0sPiEY

    fc
  11. forum rang 6 MisterBlues 24 juli 2020 18:06
    quote:

    FatCool schreef op 24 juli 2020 08:45:

    [...]
    100% mee oneens, de hoeveelheid data kan eenvoudigweg niet in een weekend worden verwerkt. En ik denk dat de werkzaamheid geweldig zal zijn.

    Ook het verplegend personeel weet precies wie er Leronlimab krijgt. Een ietwat ouder filmpje, volgens mij hier nog niet geplaatst. Na een lange inleiding over hoe zwaar ze het had gaat ze rond de 13:00 over Leronlimab praten.

    www.youtube.com/watch?v=k7O9c0sPiEY

    fc
    Ik hoopte al dat je tegengas zou geven. Ik heb zelf nog hier een gekopieerd voorbeeld gepost hoe omvangrijk die data zijn als je kijkt naar de hoeveelheid parameters. Ik ontken niet dat het veel en tijd vergend werk is. Dat neemt niet weg dat ze de leronlimab-groep kunnen vergelijken met de placebo-groep net zoals ze hebben gedaan op het gebied van veiligheid. Bij sterke werkzaamheid kan je wel zien of de eerste groep eerder geneest dan de tweede. Dat is erg belangrijk en waarom dat dan niet meedelen? Omdat het om mild en moderate gevallen gaat is dat schijnbaar niet goed waargenomen net als bij remdesivir destijds?

    Wat dan wel aan de goede kant NOG zou kunnen komen is een voorspoedig herstel zonder veel klachten dankzij leronlimab. Het kan nog meevallen maar voorlopig ga ik uit van een matige uitslag.

    Hoe leuk ook die filmpjes, het is anekdotisch bewijs. Ik wacht maar en wacht maar op heldere ondubbelzinnige verklaringen en gecompileerde data.

    Fijn weekend (en ik vind severe veel belangrijker: erg druk maak ik me niet).
  12. forum rang 6 MisterBlues 24 juli 2020 18:10
    Overigens ben ik wel nu een studie tegengekomen over RANTES van Patterson op de site nature.com

    Study in Nature Biotechnology came out on June 26, 2020     from researchers in Germany, independent of CytoDyn that supports Dr. Patterson's Rantes/CCR5 Theory. (Why this research has not made headline news on the Leronlimab boards or I missed it is surprising.) The researchers Robert Lorenz Chua, Soeren Lukassen, Saskia Trump, Bianca P. Hennig, and Daniel Wendisch, corroborate Dr. Bruce Patterson's theory that Rantes/CCR5 may become elevated due to Covid-19. If the Rantes theory for why CV19 is so deadly is found to be true, then Leronlimab is poised to make a dramatic statement with its treatment results very soon, since it is the only safe drug to target this chemokine in the treatment pipeline. This finding increases the odds that Leronlimab could very well be the CV19 wonder drug many have been hoping for, and moreover change the trajectory of this pandemic. Lastly, seeing Dr. Patterson's work replicated by an independent group nearly insures that his paper will finally get published... (rumored to be in the same journal). Dr. Patterson could very well be hailed as the scientist who made the major research breakthrough the world needed to overcome this deadly disease.

    "Our data suggest the possibility of targeting chemokine receptors. We found a significant induction of CCL2 and CCL3 expression in macrophages together with an increased expression of CCR1, the receptor for both chemokines, in patients with critical COVID-19. Because binding of CCL2 or CCL3 to CCR1, CCR2 or CCR5 can induce monocyte recruitment into the lung parenchyma with subsequent differentiation into inflammatory macrophages and consecutive recruitment and activation of additional immune cells and epithelial damage, CCR1, CCR2 and CCR5 might represent promising anti-inflammatory targets in COVID-19. Targeting the CCR2/CCL2 axis has been introduced in HIV and other viral infections53. However, we did not observe CCR2 expression in the respiratory tract of patients with COVID-19 (presumably because of its rapid downregulation in monocytes as they exit the bloodstream and enter tissues; Extended Data Fig. 7), leaving CCR1 and/or CCR5 as potential therapeutic targets."

    Here is the source... www.nature.com/articles/s41587-020-06...
  13. [verwijderd] 24 juli 2020 18:58
    MB, ze hebben al zoveel gezegd. Laten ze zich alsjeblieft inhouden, de FDA luistert mee.

    En ik heb er nul moeite mee dat ze de spanning laten oplopen. Ik hoop op de werkzaamheid in de tweede helft van volgende week, maar zal er ook niet van opkijken dat het pas na het weekend van volgende week komt. Liever grondig dan fouten maken in dit stadium, het heeft toch al zoveel tijd gekost.

    Wel hoop ik dat ze een schoonschrijver inhuren voor het persbericht. Echt belangrijk.

    fc
  15. forum rang 10 DeZwarteRidder 27 juli 2020 09:57
    Interpretation Of Cytodyn's Mild-To-Moderate COVID-19 Results
    Jul. 26, 2020 6:41 PM ET|
    176 comments
    |
    About: CytoDyn Inc. (CYDY)
    Thomas Barnard
    Thomas Barnard
    Special situations, Deep Value, long/short equity, Growth
    Summary

    Leronlimab patients had 63% less Serious Adverse Events than control subjects in mild-to-moderate patients.

    58% less patients were effected by a Serious Adverse Event.

    Leronlimab reduces the viral load in patients to zero in 14 days.

    Company plans to pursue an EUA (Emergency Use Authorization) for an unmet medical need.
    The Proposition

    The proposition of Cytodyn (OTCQB:CYDY) is that its humanized monoclonal antibody molecule, leronlimab, which blocks the CCR5 receptor on T cells and macrophages can prevent cytokine and chemokine mischief including metastasis and in the present results, the cytokine storms in the lungs resulting in acute respiratory distress syndrome (ARDS) in Covid-19 patients which leads to ventilators, and many times, in death.

    Cytodyn reported results on Tuesday morning, July 21, of a Covid-19 trial in which there were 28 control (or placebo) subjects, and 56 test subjects. Please find their Press Release here.
    Viral Load Goes to Zero

    Before I get into the numbers, I think it is important to bear in mind what Dr. Bruce Patterson, former head of Virology at Stanford, has stated a couple of times now (once in his TEDx Talk, and once in his talk with Dr. Mobeen Syed) that the viral load of the coronavirus drops to zero in 14 days. The way I interpret that it means that after 14 days there is no further infection or disease coming from the virus. But the body still needs to stop the on-going inflammation.

    Let that sink in. Eventually, the Covid cannot be found in the blood, which has to be an absolute good in the treatment of the disease.

    Dr. Patterson said in his TEDx Talk that leronlimab does three things in Covid.

    1. It quells the cytokine storm in the lungs

    2. It sets right the immune system, which can be tracked by blood markers – CD4, CD8, IL-6, CCL5.

    3. It reduces the viral load (ultimately, to zero)
    By Patients

    The company reported that 5 of the leronlimab subjects suffered Severe Adverse Events (SAEs) out of 56, and it reported that there were 6 subjects out of 28 control subjects (who got a placebo). Since the control group is exactly half of the experimental group (leronlimab), you could double the placebo group to see more closely what has happened. Apples with apples.

    12 out of 56 of the control group suffered SAE’s - 2x of (6 out of 28)

    5 out of 56 of the leronlimab group suffered SAE’s

    That means there were half as many, actually less than half patients as many suffered Severe Adverse Events with leronlimab.

    One patient died after 33 days in an event unrelated to leronlimab.
    By Events

    The company reported there were 19 Severe Adverse Events in the study. There were 11 SAEs in 6 control (placebo) patients, and there were 8 SAEs in the leronlimab group. Again doubling the control group, we have (apples with apples):

    22 SAE’s out of 56 in the control group – 2x of (11 out of 28)

    8 SAE’s out of 56 in the leronlimab group

    Again, the leronlimab group has less than half the number of SAE’s than the control/placebo group, so, it would be more desirable to be in the leronlimab group.

    I take these to be very happy results, and any sensible person would much rather be in the leronlimab group. We will get efficacy numbers soon, and eventually a safety peak at the severe-to-critical. Dr. Pourhassan has already stated a number of times that there are quite a few deaths in that study.

    Certainly, it will be important to know in severe-to-critical study at what point in the disease progression the patient got the drug. Presumably, the study will try make this the same, and to eliminate secondary conditions, but I think some stuff will still get past the filters. In the compassionate use cases, the evidence plainly shows that if the secondary conditions are serious enough, for example, in transplant patients under immune suppressive drugs, the medication does not work well enough to guarantee survival, though I think it was Dr. Bruce Patterson’s point that even in cases where the patient does not survive, the blood work is showing improvement up to the end.

    The company plans to pursue an EUA (Emergency Use Authorization) for an unmet need. Clearly, use of leronlimab would benefit the public.

    Scientists and investors will not know the full extent of leronlimab’s usefulness until the Phase III is completed, though a safety peak will be revealed perhaps four weeks after half of the 390 subjects are enrolled. Perhaps in August
    Conclusion

    Even though the stock went down after the release of these results, and media is ignoring this work, BARDA is ignoring this work, the private foundations are ignoring this work, it is, nevertheless, important work in reducing suffering.

    As far as investors are concerned, I would recommend that they pay attention to the results in all of the company’s trials, which have been stunning. In triple negative breast cancer CTC’s (circulating tumor cells) have gone to zero after 3 to 6 weeks of once-a-week injections. In HIV, viral load goes to zero (or undetectable), and now again, in Covid-19 the viral load goes to zero.

    I would recommend that investors hold fast to their shares, ignore the propaganda of short sellers, and stay the course.
  16. forum rang 6 MisterBlues 27 juli 2020 13:33
    Dit is wat mij betreft een heel goed teken: een voorlichting over de resultaten van M2M en S2C - veel eerder dan verwacht.

    Hopelijk gaan ze onder andere zeggen dat de placebo S2C groep nu l.mab gaat krijgen.

    CytoDyn to Hold Conference Call on July 30 to Provide Updates on its Two COVID-19 Trials

    July 27, 2020 6:00am EDT

    VANCOUVER, Washington, July 27, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development, and Jacob Lalezari, M.D., Senior Science Advisor, will host an investment community conference call on Thursday, July 30, 2020, to provide a comprehensive update on the Company’s two trials for COVID-19 patients with mild-to-moderate and severe-to-critical indications.

    Management will dedicate approximately 45 minutes to address questions from analysts and investors, as a follow-on to the Q&A session from the recent special meeting of stockholders.

    Date: Thursday, July 30, 2020
    Time: 1:00 p.m. PT / 4:00 p.m. ET
    Dial-In: 877-407-8291 U.S. / 201-689-8345 International

    A live audio webcast may also be accessed via CytoDyn’s corporate website at www.cytodyn.com under the Investors section/IR Calendar and will be archived for 30 days. Web participants are encouraged to go to the website 15 minutes prior to the start of the call to register, download and install any necessary software. The webcast can also be accessed via the following link:

    78449.themediaframe.com/dataconf/prod...

    A replay of the conference call will be available until August 30, 2020. To access the replay, interested parties may dial 877-660-6853 (U.S.) / 201-612-7415 (International) and enter conference identification number 13707751.

    CONTACTS
    Investors:
    Cristina De Leon
    Office: 360.980.8524, ext. 106
    Mobile: 503.214.0872
    cdeleon@cytodyn.com

    CytoDynLogo.png

    Source: CytoDyn Inc.

    Released July 27, 2020

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