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Home  /   Forum   /   BioPharma   /   OPXA - Merck partner

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OPXA - Merck partner

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153 Posts
Pagina: «« 1 ... 3 4 5 6 7 8 »» | Laatste | Omlaag ↓
  1. [verwijderd] 9 mei 2014 18:02
    The $7 billion market for SPMS is ripe for new treatments. The preferred treatments for SPMS--Avonex, Tysabri, and Tecfidera--are not even intended for the disease, and as we discussed, the drug that specifically targets SPMS is rarely used due to serious health risks. While Tcelna is far from regulatory approval and commercialization (which would happen no earlier than 2017), its safety profile has proven superior to Novantrone/Mitoxantrone. Results from the previous Phase IIb extension OLTERMS show that all 38 subjects administered Tcelna survived and experienced no serious side effects. The previous Phase II TERMS study before that, which administered Tcelna to 100 subjects (n=150), demonstrated a similar, outstanding safety profile. The next step is Phase IIb Abili-T, which is expected to administer Tcelna to 90 subjects with SPMS (n=180), and we believe the drug's established safety profile will be preserved upon completion of the trial in mid-2016. In terms of safety, we believe Tcelna is superior to Novantrone in every respect.

    Number 3. No debt. This is a very attractive quality of Opexa's financials. The company also has $23.6 million in cash as of December 2013 after conducting two common stock offerings (an aggregate of 17.64 million shares) equal to approximately $27.4 million, or approximately $24.8 million in net proceeds. As it stands, the expected cash burn rate for the remainder of 2014 is $1.2 million per month, which should decrease to about $1 million as R&D costs decline. Based on our calculations and the information provided, the company has a cash position adequate for R&D until Q4 2015. For those who are still recovering from stock price depreciation as a result of the latest common stock offerings, the reassurance that additional capital raises would likely not take place until around Q4 2015 should be comforting.

    Number 4. Sometimes it takes a trained eye to spot a diamond in the rough. Accordingly, Dr. James of Brinson Patrick so happens to be trained in neurosurgery, which we believe adds validation to our buyout thesis. Specifically, Dr. James expects that if the topline results of Abili-T are positive, Merck Serono would have to consider purchasing Opexa since the amount of money in milestone payments, license fees and royalties on global sales of Tcelna (excluding Japan, which Opexa has full commercialization and marketing rights to) could exceed $500 million if it exercises the license option.

    In fact, Opexa is primed to earn anywhere between $105-$115 million prior to FDA and EMA approval, representing at least 2.3X the company's current valuation alone. As a reminder, its current market cap is only $45 million. Further, the longer Merck Serono waits to purchase Opexa, the more money in commercial milestone payments (potentially an additional $105-$115 million) the company would unlock. Thus, any buyout offer before exercising the license option to Tcelna would be considered a viable route for Merck Serono to actually save money over the long term. Since we expect that any offer would not reflect Opexa's true valuation potential (after all, a buyout of that magnitude would be unprecedented), the only question that would remain is whether Opexa would succumb to subsequent shareholder pressure to accept what Merck brings to the table.

    Number 5. Despite the emphasis placed on target enrollment completion of Abili-T in Q2 2014 by Mr. Warma and Dr. James, it appears that the investment community is completely oblivious to this immediate value-driving catalyst (or perhaps the market correction has overshadowed it). As of February 27, the 180-patient trial was over 80% enrolled, or 145/180 patients. Given that the previous announcement on November 6 stated 100 patients had enrolled in the trial, the rate of patient enrollment over this 16-week period is approximately 2.75 patients per week. As a result, we believe strictly from a statistical standpoint that patient enrollment will be completed in May at the current enrollment rate. If successful, Opexa will initiate the 24-month trial potentially beginning its way towards advancing Tcelna to either a follow-up Phase III trial or NDAs with the FDA and EMA.

    The TERMS study and the efficacy concern

    What our interview failed to elucidate is the significant concern regarding the efficacy of Tcelna. In a previous Phase II study called TERMS (accessible here) completed in late 2008, Tcelna (then called Tovaxin) failed to show statistically significant differences in radiographic progression, the study's primary endpoint. The TERMS study consisted of 150 patients with RRMS or high risk Clinically Isolated Syndrome (CIS), with a duration of observation limited to 12 months. Although the disappointing results were seriously detrimental to shareholder value at the time, there is compelling data to suggest that the reason for the statistically insignificant finding was not due to a lack of efficacy, but rather, limitations in the study's parameters. Precisely, the 12-month observation period might not have been adequate in order to ascertain statistically significant differences in radiographic progression. This is supported by the following data analysis taken from a subgroup in the TERMS study:

    (click to enlarge)

    (Source: www.opexatherapeutics.com)

    As displayed above, the subgroup of the TERMS study yielded three significant findings:
    1.More than 83% of Tcelna patients remained relapse free after one year.
    2.There was a 55% reduction in Annualized Relapse Rate (ARR) compared to placebo.
    3.A total of 73% of Tcelna patients showed improvement or stabilization in more active MS (MS disability), accompanied by 16.5% of those patients achieving sustained improvement by greater than one full point.

    Why is this important? This subgroup consisted of patients with more active MS, which is similar to patients with SPMS. The fact that Tcelna was able to produce these results in 142 cases suggests that further research is warranted to determine whether the drug is effective in SPMS and RRMS. Nevertheless, investors should be aware of the past failures of Tcelna. While we expect that these significant findings could translate to successful topline results from the Abili-T study for SPMS, the trial has yet to complete patient enrollment (expected in May), and we will not have a full understanding of the efficacy or safety of Tcelna until mid-2016. Needless to say, Opexa's lifeline is in the future of Tcelna for RRMS and SPMS, and any clinical mishap, such as the one that plagued the TERMS study, would result in catastrophic depreciation of shareholder value.
  2. [verwijderd] 9 mei 2014 18:03
    Tysabri and Lemtrada: Opexa's emerging competitors

    Many investors forget that Biogen Idec (BIIB) and Elan initiated a global Phase III study, called ASCEND, to evaluate Tysabri as a treatment for SPMS in 2012. The theory behind targeting this indication is that Tysabri could lower chronic inflammation associated with disease progression in SPMS. While this could prove effective, it is possible that the relatively closed blood-brain-barrier (BBB) in SPMS patients will reduce the efficacy of Tysabri by decreasing its penetration. The primary endpoint of the study is a measurement of disability progression not related to relapses. This study is expected to be completed in December 2014, and if the primary endpoint is met without serious safety concerns, we expect the drug to receive regulatory approval. We have highlighted safety as a primary concern for Tysabri due to previous findings from the Phase III AFFIRM study, which found that in spite of reducing the relative risk of disability progression by 42-54%, Tysabri increases the risk of progressive multifocal leukoencephalopathy (PML). PML is a viral infection of the brain, which "usually leads to death or serious disability," according to Biogen's Tysabri web page. Thus, investigators will have to scrutinize the results of the ASCEND trial to determine whether the risk of PML associated with Tysabri outweighs its benefits in reducing the risk of disability progression. Ultimately, we believe that it is possible Tysabri could fall into the same boat as Novantrone and receive a black label warning if it ever gets approved for SPMS.

    Another competing drug in the progressive MS space is Lemtrada owned by Genzyme, a Sanofi (SNY) company. Lemtrada is an immunosuppressor that targets the surface CD52 receptor on monocytes, B cells and T cells. Despite being the original treatment for SPMS, Lemtrada was found to be less effective in patients that have entered the neurodegenerative phase of MS due to the fact that patients in the more progressive phase continued to accrue disability. As a result, there is a serious concern that the drug itself is simply not adequate for progressive forms of MS. Case in point, the FDA recently rejected the NDA for Lemtrada, stating that additional research was required to determine whether the drug's benefits outweigh its serious safety risks. That research has since been completed, and on April 7, Genzyme announced that it would resubmit the NDA for Lemtrada. Again, investigators will heavily scrutinize this risk-benefit dynamic, and we suspect that the FDA could reject it for a second time if this drug is found not to be favorable for progressive MS patients.

    While we are encouraged by Tcelna's outstanding safety profile and are confident that its sales potential is substantial, it is important to realize that if Lemtrada and Tysabri are approved, the potential market share for Tcelna could decline in the SPMS and RRMS space. However, the degree of which sales would decline is impossible to determine.

    Risk overview

    Investors should be aware that clinical-stage biopharmaceutical companies are high-risk investments. As we have already noted some of the more significant risks in earlier sections, investors should also be aware of the following:
    •Proper execution: Given that there already has been extensive clinical research conducted on Tcelna, which has led to desirable findings, we have no reason to believe that management will execute poorly. However, due to a single clinical mishap, which occurred nearly seven years ago, we cannot exclude poor execution as a possibility. In particular, the disappointing results from the TERMS study (which we previously discussed) serves as a prime example of the risks associated with clinical-stage biopharmaceutical investments. Having said that, we believe that the risk of clinical shortcomings in the Abili-T trial has been reduced as a result of Opexa's success in granting Merck Serono an option to license Tcelna. Merck is one of the largest pharmaceutical companies in the world, and we perceive its interest in commercializing Tcelna as validation of the drug's safety and efficacy potential within itself.
    •Given the current cash position of $23.6 million and a cash burn rate of approximately $1 million, we believe that Opexa has enough money to advance the ongoing Abili-T trial to Q4 2015. However, we expect that future clinical expenses will necessitate additional cash raises prior to this point. Therefore, the risk of shareholder dilution is real, and investors should be aware that Opexa's R&D will require more cash than what is currently on hand. In light of the conditions prior to earlier share offerings, also be aware that management is very strategic with their placements of common stock offerings. With that, a fascinating proverb comes to mind: "Pigs get fatter, hogs get slaughtered." In other words, do not be greedy. The advisable strategy is to take profits after a spike in share price so as to avoid becoming a victim of a similar situation to the one that occurred on August 7, 2013.
    •Due to financial constraints, enrollment for the study was slower than expected. Investors should be aware that additional delays could ensue, as well as problems with the efficacy and/or safety of Tcelna. Ultimately, Tcelna is an experimental therapy. As with any experimental therapy, the risks above are real. In addition, if Opexa is unable to secure significant additional resources to continue funding the development of Tcelna, this could have an adverse impact on the ongoing Abili-T trial.
    •With the license arrangement with Merck Serono, two risks arise. First, if Merck exercises its option to license Tcelna, Opexa would be completely reliant on Merck to conduct further clinical research and development of the drug, as well as commercialization (excluding Japan). If Merck fails to develop the product for whatever reason, Opexa would lack the funds to pursue development alone. The second risk is if Merck decides not to exercise the option to license Tcelna. If this occurs, Opexa would either have to pursue development of the drug alone (which would require drastic shareholder dilution), or the company would have to find another partner potentially under a less attractive arrangement. Neither option is ideal, and investors should realize that either outcome is certainly possible.
    •The final risk is simple: Opexa is almost completely reliant on the success of Tcelna. The company has invested approximately $140 million in developing the drug with no tangible results (i.e. a commercialized product). As CFO Radhakrishnan also noted, Opexa has no marketed products, hence no revenue growth. Therefore, if anything goes wrong in the development of Tcelna, such as delays, inefficacy and/or safety problems and insufficient funds to sustain further clinical research, catastrophic shareholder depreciation could ensue.
  3. [verwijderd] 9 mei 2014 18:03
    Conclusion

    Based on our extensive analysis and interviews with CEO Warma, CFO Radhakrishnan and Dr. James of Brinson Patrick, we conclude that Opexa is an optimal buyout candidate pending successful topline results of the Abili-T trial. We see no reason that Merck Seronos would risk coughing up in excess of $500 million in milestone payments, license and royalty fees when it could purchase Opexa at a fraction of that price. After all, Opexa's market cap is $45 million, and we believe it would not take a very high premium to the current share price in order to entice management into accepting a buyout offer. Further, we are encouraged that Dr. James, a specialist in neurosurgery who has vast knowledge of Tcelna and the underpinnings of the SPMS and RRMS markets, has lent credence to our claim, and we are confident that an investment at current levels represents a deep discount to Opexa's fair market valuation. Nevertheless, we strongly believe this investment opportunity is fleeting as completion of patient enrollment could be announced in the coming weeks along with a new drug indication, both of which could send shares above pre-correction levels.

    Editor's Note: This article covers a stock trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.
  10. gustaaf1e 14 augustus 2014 19:55
    THE WOODLANDS, Texas--(BUSINESS WIRE)-- Opexa Therapeutics, Inc. (NASDAQ:OPXA), a biotechnology company developing Tcelna®, a novel T-cell immunotherapy for the treatment of secondary progressive multiple sclerosis (SPMS), today announced that the Company will report financial results for the three months ended June 30, 2014 after the close of trading on Thursday, August 14th. The Company will also conduct a conference call and webcast to discuss financial results and provide a corporate update at 5:00 P.M. EDT on Thursday, August 14th.

    G
  12. gustaaf1e 15 augustus 2014 13:02
    Eigenlijk geen nieuws, deze cijfers. Cash tot in 2e helft 2015 en top-line results 2e helft 2016. Dus kans op missie midden volgend jaar, tenzij Merck tussentijds nog bijspringt naar aanleiding van tussentijdse resultaten.
    Indien emissie, dan nog geen man over boord, want hebben (relatief) weinig aandelen uitstaan.

    G
  14. [verwijderd] 9 september 2014 12:25
    Update: Opexa Announces New Indication
    Sep. 9, 2014 4:14 AM ET | About: Opexa Therapeutics, Inc. (OPXA), Includes: MRK
    Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)
    Summary

    Opexa officially announces development of a second indication in Neuromyelitis optica, commonly referred to as Devic's syndrome.
    I reiterate my bull thesis on Opexa given the versatility of the T-cell technology platform.
    In my initial report, I anticipated that Opexa would announce a new indication. The latest announcement corroborates this position.
    In April, I wrote a PRO article on Opexa Therapeutics (NASDAQ:OPXA) with a thesis stating that ongoing clinical success of Opexa's lead drug candidate, Tcelna (imilecleucel-T), could translate to regulatory approval and potentially fill a significantly unmet medical need in patients with Secondary Progressive Multiple Sclerosis (SPMS). I also argued that Merck Serono, the biopharmaceutical division of Merck (NYSE:MRK), which has option and licensing rights to Tcelna, could acquire Opexa at a substantial discount before exercising its option in order to avoid hefty milestone and royalty payments if and when the product is commercialized. Opexa's latest announcement of its plans to target Devic's syndrome with OPX-212 via its T-cell platform, gives me no reason to amend my buyout thesis on Opexa.

    Some key highlights of Opexa's latest announcement are as follows:

    Ongoing preclinical activities are expected to translate to IND filing with the FDA by mid-2015. Successful development could lead to Phase 1/2 proof-of-concept study initiated shortly afterwards.
    Opexa believes the compound will qualify for Orphan drug designation and intends to apply for Fast Track designation, which could increase the market potential of OPX-212 and expedite its development, respectively.
    There is currently no FDA approved treatment for Devic's syndrome.
    Opexa expects that the development of OPX-212 will not cause a meaningful increase in cash burn, potentially leaving plenty of runway for the simultaneous development of the Tcelna program.
    Although OPX-212 is in preclinical development, I believe the achievement of a second indication is healthy for Opexa. As a reminder, the company is completely dependent on the success of its ongoing Abili-T Phase 2b clinical trial of Tcelna for SPMS, so the incorporation of this T-cell mediated autoimmune disease indication should help diversify Opexa's risk profile. For shareholders, this translates to additional catalysts including a potential IND filing with the FDA in mid-2015, followed by a possible Phase 1/2 proof-of-concept study. Moreover, Opexa expects that ongoing development of this program will not increase cash burn, which currently stands at $4.5 million per quarter. Thus, the company should have enough runway for R&D until 4Q 2015. As the company remains on course to provide a topline readout for the Abili-T study in the first half of 2016, preceded by catalysts related to OPX-212, I see no reason to amend my bull thesis on Opexa.

    Editor's Note: This article covers a stock trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.
  16. [verwijderd] 10 september 2014 10:59
    Goed idee, bijkopen, alleen ben ik zelf nogal volbehangen met Opexa inmiddels, ben gaan kopen vanaf een niveau van $ 1,40, heeft me dus nog geen echte plus opgeleverd.
    Medio 2015 zou Merck wel eens kunnen gaan zwaaien met de portemonnaie.
    Ik schat, ingegeven door de berichtgeving, de kans op een overname door Merck Serono op meer dan 50%.
    Sommige ontwikkelingen zijn zeer goed voorspelbaar, het geld ligt soms op straat (Nokia, TomTom, Yahoo) als je op tijd inslaat.
  17. [verwijderd] 16 september 2014 17:38
    Update: Opexa Unveils Financial Woes - Shares Drop
    Sep. 16, 2014 7:05 AM ET | 6 comments | About: Opexa Therapeutics, Inc. (OPXA), Includes: MRK
    Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)
    Summary

    Opexa announces plans to conduct a near-term public offering. Shares are down more than 10% in after hours.
    Despite the short-term impact on share price, I reaffirm my buyout thesis due to Opexa's positive pipeline developments, including targeting a new indication and completing enrollment for the Abili-T study.
    In my initial report, I didn't anticipate Opexa's near-term plans to conduct additional financing.
    In April, I wrote a PRO article on Opexa Therapeutics (NASDAQ:OPXA) with a thesis stating that ongoing clinical success of Opexa's lead drug candidate, Tcelna (imilecleucel-T), could translate to regulatory approval and potentially fill a significantly unmet medical need in patients with Secondary Progressive Multiple Sclerosis (SPMS). I also argued that Merck Serono, the biopharmaceutical division of Merck (NYSE:MRK), which has option and licensing rights to Tcelna, could acquire Opexa at a substantial discount before exercising its option in order to avoid hefty milestone and royalty payments if and when the product is commercialized. As I discussed in an earlier update article, Opexa's announcement of a new indication potentially increases the company's market valuation, and, in turn, supports my original bull thesis. Today, however, we learned that Opexa plans to conduct a near-term public offering, underscoring its financial struggles. Despite this concern, I reaffirm my bull thesis because I believe Opexa's remains on course to provide a topline readout on the ongoing Abili-T trial in 1H 2016, preceded by possible IND filing for OPX-212.

    Some key highlights of Opexa's latest announcement are as follows:

    No details on the actual size or terms of the offering.
    Depending on market conditions, the offering may or may not be completed.
    Net proceeds are expected to support the ongoing Abili-T clinical study of Tcelna in patients with Secondary Progressive MS, the preclinical development of OPX-212 in patients with neuromyelitis optica (NMO), and a possible IND filing with the FDA for a Phase 1/2 proof-of-concept study.
    Aegis Capital Corp. is serving as the book-running manager in the offering.
    Ultimately, I found the announcement of another offering surprising. With a $4.5 million cash burn per quarter, I expected Opexa to have enough runway for R&D going into mid 2015. After all, it has stated that it expects the ongoing preclinical development of OPX-212 will not increase cash burn, while reporting a strong cash position of $16 million for Q2 2014. Based on this information, I believe Opexa expects to submit an IND application with the FDA and advance OPX-212 to a Phase 1/2 proof-of-concept study. This makes sense considering that this development would significantly increase cash burn, and no other expenditure (excluding general corporate items) would warrant an offering at this time. Nevertheless, investors should be wary of Opexa's financial struggles going forward, as management has proven to be unpredictable when it comes to the timing of offerings. Having said that, the company remains on course to provide a topline readout for the Abili-T study in 1H 2016, preceded by catalysts related to OPX-212, which should alleviate long-term pressure on the equity caused by the latest offering.

    Editor's Note: This article covers a stock trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.
  18. [verwijderd] 16 september 2014 17:54
    Tjonge jonge, ze kondigen een aandelenplaatsing aan die ze een dag later weer intrekken.
    Met desastreuze gevolgen voor de koers.
    Blijkbaar was extra geld nodig voor de 2de toepassing van hun T-cell platform, de Ziekte van Devic, een andere vorm van MS: nl.wikipedia.org/wiki/Neuromyelitis_o...
    Net als SPMS een auto immuun ziekte.
    Aan de fundamenten is niets veranderd, maar het kan zijn dat de ontwikkeling van Tcelna, het middel tegen SPMS, niet naar wens verloopt, en er daarom een tweede toepassing wordt opgestart. Waar gisteren nog extra geld voor nodig was, maar nu blijkbaar niet meer.
    Wel een misser van formaat van het management.
    Is het nu een goedkoop instapmoment of gaan we nog verder omlaag?
    Ik denk het eerste, en koop er een paar duizend bij, limiet $ 1,11.
  19. gustaaf1e 16 september 2014 20:46
    Ja, dit komt wel knullig over. Ik kan van de andere kant wel respect opbrengen voor een management dat zo'n stap durft te zetten. Reden voor het intrekken van de emissie is dat na het aankondigen ervan de koers drastisch inzakte. Men kon het naar de aandeelhouders toe nu niet meer maken om op deze prijs met een emissie te komen.
    Helaas is het effect nu toch een fors dalende koers. Ik ben echter ook overtuigd dat hier kansen liggen.
    G
  20. [verwijderd] 2 oktober 2014 22:49
    Ze hebben wat goed te maken:

    Opexa Therapeutics Announces Analyst and Investor Event

    10/02/2014
    THE WOODLANDS, Texas--(BUSINESS WIRE)-- Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical company developing personalized immunotherapies for autoimmune disorders, including multiple sclerosis (MS) and Neuromyelitis Optica (NMO), today announced that it will hold an Analyst and Investor Event in New York City, New York on Thursday, October 9, 2014.

    Members of Opexa’s senior management team will provide an R&D update and review of the Company’s Abili-T clinical trial for Secondary Progressive Multiple Sclerosis and the development program for Neuromyelitis Optica.

    The Analyst and Investor Event will take place from 8:00 a.m. to 9:15 a.m. Eastern Time at the New York Hilton Midtown, Madison Room (2nd floor). If you would like to attend the event, please confirm your attendance by e-mail to czuckero@opexatherapeutics.com or via telephone at 281.775.0600.

    A live webcast of the event will start at 8:15 a.m. and may be accessed on the Investor Relations section of the Company’s website, www.opexatherapeutics.com. An archived version of the webcast will be available for 90 days after the event on the Company’s website.
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Van Lanschot Kempen NV 41,950 -0,05 -0,12%
WDP 20,540 -0,02 -0,10%
SIGNIFY NV 20,980 -0,02 -0,10%
IMCD 139,350 -0,10 -0,07%
vlag naam koers verschil relatief verschil
AEX 875,26 +0,12 +0,01%
AEX GR 3.431,01 -1,58 -0,05%
Germany40^ 19.266,20 -29,78 -0,15%
FTSE 100 8.249,68 -8,93 -0,11%
EURO50 4.739,79 -19,13 -0,40%
US30^ 44.913,10 +63,30 +0,14%
Nasd100^ 20.888,20 -35,20 -0,17%
US500^ 6.018,13 -4,03 -0,07%
Japan225^ 38.071,90 -261,30 -0,68%
VD-NEW 15,60 +0,26 +1,69%
#/^ Index indications calculated real time, zie disclaimer