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Merus NV NL0011606264

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Merus NV forum geopend

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Pagina: «« 1 ... 6 7 8 9 10 ... 52 »» | Laatste | Omlaag ↓
  1. Omegaplan 11 juli 2017 22:21
    Balance sheet strengthened with $120 million upfront payment and an $80 million share purchase from Incyte Corporation for global strategic research collaboration to discover and develop bispecific antibodies

    Based on single agent activity in the MCLA-128 Phase 1/2 clinical trial, Phase 2 combination clinical trials planned to initiate in second half of 2017 for MCLA-128 in two metastatic breast cancer populations: HER2-positive patients and hormone receptor-positive/HER2-low patients

    Conference call and webcast to be held today at 4:30 pm ET

    UTRECHT, The Netherlands, July 11, 2017 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced financial results for the first quarter ended March 31, 2017 and provided a corporate and clinical update.

    “The first quarter and recent period were marked most notably by the announcement of Phase 1/2 clinical trial data for our lead product candidate MCLA-128, an ADCC-enhanced Biclonics® designed to bind to and block growth factor receptors HER2 and HER3, which demonstrated single-agent anti-tumor activity in a heavily pre-treated cohort of metastatic breast cancer (MBC) patients,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. “Given these encouraging results, we plan to initiate a Phase 2 open-label, multicenter clinical trial of MCLA-128 in HER2-positive MBC patients and in hormone receptor-positive/HER2-low MBC patients in the fourth quarter of 2017.”

    Dr. Logtenberg continued, “Also in the second half of this year, we expect to reach important clinical and regulatory milestones for two other Biclonics® therapeutic candidates, MCLA-117 and MCLA-158. Biclonics® are designed to have functionalities that compare favorably against other forms of immunotherapeutics, such as conventional mAbs as well as their combinations, and have the potential to be a more effective treatment for cancer patients. With the Biclonics® therapeutic candidates arising from this platform now emerging in the clinic, we look forward to providing additional updates across our pipeline in the coming quarters.”

    Recent Developments

    At the 2017 American Society of Clinical Oncology (ASCO) in May 2017, Merus presented a poster entitled, “First in human phase 1/2 study of MCLA-128, a full length IgG1 bispecific antibody targeting HER2 and HER3; final phase 1 data and preliminary activity in HER2+ metastatic breast cancer (MBC),” which detailed clinical results from a Phase 1/2 clinical trial of MCLA-128 in solid tumors, including final Phase 1 data in patients with HER2+ MBC. Part 1 of the Phase 1/2 clinical trial showed that MCLA-128 was safe and well-tolerated and established the Phase 2 recommended dose of MCLA-128 in a cohort of 28 advanced solid tumor patients.

    In the ongoing Part 2 of the study, treatment was completed for a cohort of heavily pre-treated HER2+ MBC patients (n=11) using MCLA-128 as a single agent. Overall, the clinical benefit rate (defined as complete response plus partial response plus stable disease lasting at least 12 weeks) among a total of 11 MBC patients was 64%. Evaluation of MCLA-128 in other indications, including endometrial, ovarian, and gastric cancers and NSCLC is ongoing.

    Shelley Margetson, Chief Operating Officer, will leave the Company effective August 1, 2017. Ms. Margetson has served in her current role since November 2016. She also served as Executive Vice President and Chief Financial Officer of Merus from 2010 until 2016.
    Anticipated 2017 Milestones
  2. visje2 12 juli 2017 08:51
    Logtenberg en Merus moeten nog een hoop leren op het vlak van investor communicatie.
    Er was gisteren een webcast maar heb deze helaas nog niet kunnen vinden op hun website.
    Wellicht is dit de reden voor het vertrek van de COO na nog geen 1 jaar in haar nieuwe functie.
    Hopen maar op verbetering in de werkwijze.
    Zou zeggen ga eens praten met een ex Crucell collega die nu Galapagos leidt, wellicht een goed voorbeeld?
  3. [verwijderd] 13 juli 2017 09:37
    Ton heeft ervaring genoeg van zijn Crucell verleden en dat de webcast er nog op stond zal verklaarbaar zijn. Dat Shelley weg gaat is niet zo vreemd want ze heeft wel vaker kortere en langere tijd ergens gewerkt en wil weer wat anders. dus geen issue. De vraag is of de in Mei gepresenteerde poster overtuigend genoeg was voor de bispecifieke monoclonal tegen Her2 en Her3. Hoewel de fase 2 studie verder gaat en wordt uitgebreid naat andere kankers is dit wel een heel lastige target groep maar hoog risico. Maar het platform en muis model om bispecifieke te maken is wel de toekomst en de reden dat Incyte zo fors is ingestapt.
  4. Omegaplan 28 juli 2017 13:39
    News Release
    U.S. COURT OF APPEALS FOR THE FEDERAL CIRCUIT AFFIRMS MERUS’ INEQUITABLE CONDUCT CLAIM AGAINST REGENERON

    UTRECHT, The Netherlands, July 28, 2017 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that the U.S. Court of Appeals for the Federal Circuit affirmed the trial court’s conclusion that Regeneron Pharmaceuticals, Inc. engaged in inequitable conduct before the United States Patent and Trademark Office while prosecuting U.S. Patent No. 8,502,018 (‘018 patent), entitled “Methods of Modifying Eukaryotic Cells.”

    In today’s decision, the Federal Circuit ruled fully in favor of Merus, affirming that Regeneron’s ‘018 patent is unenforceable, having been obtained by inequitable conduct. The Federal Circuit noted Regeneron made “false” assertions, relied on a “misleading presentation,” and withheld material information from the United States Patent Office, and further, that Regeneron’s “litigation misconduct” “obfuscated its prosecution misconduct.”

    “We are pleased by today’s decision, which serves as the latest vindication for Merus in this case against Regeneron,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. “With this decision, and based on the continued strength of our IP estate, Merus remains focused and believes it is well-positioned as an innovator in the development of full-length human bispecific antibody therapeutic candidates for serious diseases.”

    About Merus N.V.

    Merus is a clinical-stage immuno-oncology company developing innovative full-length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics® are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to have several of the same features of conventional monoclonal antibodies, such as long half-life and low immunogenicity. Merus’ lead bispecific antibody candidate, MCLA-128, is expected to begin a Phase 2 clinical trial in the second half of 2017 in two metastatic breast cancer populations. MCLA-128 is also being evaluated in a Phase 1/2 clinical trial in Europe in gastric, ovarian, endometrial and non-small cell lung cancers. Merus’ second bispecific antibody candidate, MCLA-117, is being developed in a Phase 1 clinical trial in patients with acute myeloid leukemia. The Company also has a pipeline of proprietary bispecific antibody candidates in preclinical development, including MCLA-158, which is designed to bind to cancer stem cells and is being developed as a potential treatment for colorectal cancer and other solid tumors, as well as MCLA-145 designed to bind to PD-L1 and a non-disclosed second immunomodulatory target, which is being developed in collaboration with Incyte Corporation.

    Forward Looking Statement

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.
  5. [verwijderd] 28 juli 2017 20:17
    Speelt al heel lang en keer op keer krijgt Regeneron ongelijk en vindt dit zo vervelend dat ze deze kans niet kunnen benutten op bispecifieke ab terrein. Snap alleen niet dat ze al tientallen miljoenen hebben gespendeerd en kans op celstraf lopen terwijl ze zeker 2 jaar geleden voor een redelijk bedrag Merus hadden kunnen kopen. Nu wordt lastiger met o.a. een Incyte aan boord. Koers zal wel weer gaan oplopen.
  6. KAKO 30 augustus 2017 11:08
    Enig idee wanneer we weer wat actie kunnen verwachten? Van welke resultaten moet het gaan komen? Of, op welk bericht wachten jullie...
  7. Omegaplan 30 augustus 2017 14:31
    Zeker actie en wel in september MERUS TO PARTICIPATE IN TWO INVESTOR CONFERENCES IN SEPTEMBER 2017

    UTRECHT, The Netherlands, Aug. 30, 2017 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced that Ton Logtenberg, Ph.D., Chief Executive Officer, will participate at two upcoming investor conferences in September:

    Citi’s 12th Annual Biotech Conference on Thursday, September 7, 2017 at the Mandarin Oriental Hotel in Boston, MA

    LEERINK Partners Roundtable Series: Rare Disease & Immuno-Oncology on Thursday, September 28, 2017 at the Lotte New York Palace Hotel in New York, NY
  8. Pokerface 19 september 2017 22:51
    MERUS ANNOUNCES SECOND QUARTER 2017 FINANCIAL RESULTS AND HIGHLIGHTS RECENT PROGRESS

    UTRECHT, The Netherlands, Sept. 19, 2017 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics (Biclonics®), today announced financial results for the second quarter ended June 30, 2017 and provided a corporate and clinical update.

    “Merus has had a productive year to date, marked by progress in our work with Incyte and our other collaborators, the presentation at ASCO of positive Phase 1/2 data for our lead candidate MCLA-128 in the first of several indications, and progress among a stable of very exciting Biclonics®-based bispecific antibody therapy candidates toward and through the clinic,” said Ton Logtenberg, Ph.D., Chief Executive Officer of Merus. “We believe that the potential of Merus’ Biclonics® platform, which holds a number of key advantages over other bispecific antibody approaches, has only just begun to reveal itself.”

    “The balance of the year holds a number of key anticipated milestones, including initiating a Phase 2 trial of MCLA-128-based combinations in two metastatic breast cancer (MBC) populations, a decision on development of MCLA-128 in gastric, ovarian and endometrial cancers based on an expected data readout, progression of dose escalation in the Phase 1 trial evaluating MCLA-117 in acute myeloid leukemia (AML) under a Clinical Trial Authorization (CTA), filing of an Investigational New Drug (IND) submission for MCLA-117, and filing of a CTA for a first-in-human clinical trial of MCLA-158 in patients with colorectal cancer. We also look forward to initiating an IND-enabling study for MCLA-145, a bispecific antibody designed to bind to PD-L1 and to another undisclosed immunomodulatory target, a program that is part of our collaboration with Incyte,” added Dr. Logtenberg.

    Recent Clinical & Corporate Developments

    In Part 2 of the Phase 1/2 MCLA-128 study in solid tumors, treatment was completed for a cohort of heavily pre-treated HER2+ MBC patients (n=11) using MCLA-128 as a single agent which resulted in an overall clinical benefit rate (defined as complete response plus partial response plus stable disease lasting at least 12 weeks) of 64%. With single agent activity established in MBC, the initiation of a Phase 2 clinical trial is anticipated in the fourth quarter of 2017 described further below under “Anticipated 2017 Milestones”.

    Merus and Incyte Corporation (NASDAQ:INCY) have advanced the first candidate from their global strategic research collaboration into an IND-enabling study. MCLA-145 is designed to bind to PD-L1 and to a second undisclosed immunomodulatory target to treat various solid tumors. Merus has full rights to develop and commercialize MCLA-145 in the United States and Incyte is responsible for its development and commercialization outside the United States.

    Merus received a favorable ruling from the U.S. Court of Appeals for the Federal Circuit which affirmed that Regeneron Pharmaceuticals engaged in inequitable conduct during the patent prosecution of U.S. Patent No. 8,502,018, resulting in the patent’s unenforceability.
    Anticipated 2017 Milestones

    During the fourth quarter, Merus expects to initiate a Phase 2, open label, multi-center international clinical trial to evaluate MCLA-128-based combinations in two MBC populations: (1) confirmed HER2-positive MBC patients (progressing on 2 to 4 anti-HER2 therapies, including TDM-1) who will receive MCLA-128 in combination with trastuzumab with and without chemotherapy, and (2) confirmed ER+/HER2-low MBC patients progressing on one or more prior endocrine therapies and CDK4/6 inhibitors who will receive MCLA-128 in combination with endocrine therapy. The trial is expected to enroll approximately 120 patients in total with approximately 60 patients targeted in each cohort.

    Merus is continuing its dose escalation of the Phase I clinical trial for MCLA-117 in Europe and expects to submit an IND application to the U.S. Food and Drug Administration in the fourth quarter of 2017.

    By the end of 2017, Merus expects to file a CTA for a first-in-human clinical trial of MCLA-158 in patients with colorectal cancer.

    Second Quarter 2017 Financial Results

    Merus ended the second quarter of 2017 with cash and cash equivalents of €215.8 million compared to €56.9 million at December 31, 2016.

    Total revenue for the three months ended June 30, 2017 was €4.0 million compared to €1.1 million for the same period in 2016. Revenue is comprised primarily of amortization of the Incyte upfront license payment, research funding and income from grants on research projects.

    Research and development costs for the three months ended June 30, 2017 were €8.4 million compared to €3.8 million for the same period in 2016. The increase in research and development costs quarter over quarter, reflects higher enrollment in our clinical trials and expansion of pre-clinical research efforts to support our collaboration with Incyte.

    For the three months ended June 30, 2017, Merus reported a net loss of €21.8 million, or a loss of €1.12 per basic and diluted share, compared to a net loss of €4.9 million, or a loss of €0.40 per basic and diluted share, for the same period in 2016. The net loss for the three months ended June 30, 2017 includes approximately €12.0 million of unrealized foreign currency losses and approximately €3.3 million of non-cash, share option expenses.

    Financial Outlook

    Based on current operating plans, Merus expects that its current cash and cash equivalents balance will be sufficient to fund its research and development programs and operations well into 2019.
  9. Omegaplan 20 september 2017 23:00


    MERUS’ INTELLECTUAL PROPERTY PORTFOLIO EXPANDS WITH TWO NEW PATENTS FOR ITS BICLONICS® TECHNOLOGY

    UTRECHT, The Netherlands, Sept. 20, 2017 (GLOBE NEWSWIRE) -- Merus (NASDAQ:MRUS), a clinical-stage immuno-oncology company developing therapeutics with the goal of treating and curing serious illnesses, announced today that it has added to its deep intellectual property portfolio two new U.S. patents related to its proprietary Biclonics® technology for developing novel bispecific antibodies.

    On September 19, 2017, the United States Patent Office (USPTO) granted U.S. Patent No. 9,765,133, entitled “Antibody Producing Non-Human Mammal”, which marks a first U.S. patent covering a transgenic mouse having a common light chain, related to Merus’ MeMo® mouse technology. Using MeMo®, a leading antibody-generating platform, Merus is able to produce large and diverse panels of high affinity common light chain antibodies against a broad variety of targets, which can then be used to make high quality bispecific antibodies referred to as Biclonics®.

    On August 22, 2017, the USPTO also granted U.S. Patent No. 9,738,701 entitled, “Method for selecting a single cell expressing a heterogeneous combination of antibodies,” which relates to downstream host cells capable of effectively manufacturing Biclonics®.

    “These issuances continue to complement Merus’ substantial and growing patent portfolio related to each stage of what we believe to be an industry-leading bispecific antibody platform based on our proprietary Biclonics® suite of technologies,” said Dr. Ton Logtenberg, Chief Executive Officer of Merus. “The issuance of these patents strengthens our intellectual property estate, which ranges from technology concerning the use of transgenic mice to develop large panels of common light chain antibodies, to the generation of host cells capable of manufacturing high quality bispecific antibodies with differentiated modes of action.”

    Merus has obtained patents worldwide, including throughout Europe, Asia, Australia and now the US related to its MeMo® technology, with several additional applications still pending in the US. These two recent issuances by the USTPO bolster the Company’s substantial estate related to the panoply of Biclonics® technologies, including transgenic rodents, production of antibody libraries, screening methods, Fc engineering, antibody host cell expression and preclinical and clinical bispecific antibody candidates.
  10. KAKO 21 september 2017 01:47
    quote:

    Omegaplan schreef op 20 september 2017 23:04:

    Vandaar vandaag in de 17. Regionen. Uiteindelijk plus ruim 6%.
    Wellicht kunnen we weer richting 25.

    Zou mooi zijn maar denk dat we voorlopig even geduld moeten hebben! In hoeverre vind jij Merus eigenlijk een overnamekandidaat?
  11. Prof. Dollar 22 september 2017 19:08
    Ik volg Merus al een tijdje maar niet dit specifieke forum. Ik heb enkele vragen. Ik zou graag wat meer willen weten over het Biclonics platform, wat houden de concurrentievoordelen precies in? En er zijn in het vierde kwartaal meerdere catalysts, wat is de verwachting?
  12. [verwijderd] 25 september 2017 11:22
    Het Biclonics platform is zo waardevol dat Regeneron al geschat 100 Miljoen USD aan legal inbreuk kosten voor heeft gemaakt...Inhoudelijk maakt het diermodel bispecifieke antibodies die beter worden gehad dan de huidige antibodies op de markt.
  13. Hoeki 3 oktober 2017 16:52
    Ik kwam vorige week in het boek over Crucell dit bedrijf tegen. Heb wat research en ik heb wel vertrouwen in dit aandeel. Ik heb net na anderhalf jaar 22% van mijn positie Ablynx verzilverd(was verreweg te groot in mijn portefeuille) en een order ingelegd op $20,20. Heeft iemand misschien een handige site waar een live koers met 5 laags orderboek te volgen is? Degiro heeft 15 minuten vertraging en laat mijn order gekgenoeg ook niet eens zien in de bied, volgensmij hebben ze daar wat technische problemen.
  14. [verwijderd] 3 oktober 2017 23:31
    quote:

    FatCool schreef op 15 juni 2017 23:07:

    Vooruit dan maar; een klein plukje op $13,72 voor een gokje.
    Vandaag verkocht op $20.55.

    Reden van verkoop: iets minder diep in oncologie. Daarnaast wil ik nog wat meer geld vergokken op AVXL :).

    Ik blijf dit aandeel volgen. Succes allen!!

    fc
  15. [verwijderd] 5 oktober 2017 17:45
    Fatcool gefeliciteerd met je snelle winst en grappig de een stapt in en de ander uit. en van winst nemen is niemand armer geworden. Ik zit echter in biotech land en zie dat Ton cs heel erg goed bezig is en dat dit biclonics platform echt bijzonder wordt gewaardeerd waardoor o.a. rond de kerst er zo fors is ingestapt door Incyte met 120M upfront en dat een regeneron maar blijft door procederen om patent onderuit te krijgen wat niet lukt. OOk Merus gebruikt net als Argenix de diversiteit van een lama platform en de waardering kan echt Galapagos of beter Genmab 12 miljard (?) achterna. Dus ik blijf lekker vol zitten
  16. Hoeki 10 oktober 2017 22:25
    MERUS TO PARTICIPATE IN THE BIO INVESTOR FORUM

    UTRECHT, The Netherlands, Oct. 10, 2017 (GLOBE NEWSWIRE) -- Merus N.V. (NASDAQ:MRUS), a clinical-stage immuno-oncology company developing innovative bispecific antibody therapeutics, today announced that Ton Logtenberg, Ph.D., Chief Executive Officer, will be participating in the 2017 BIO Investor Forum in a panel entitled, “Bispecific Antibodies to Supercharge Oncology Treatments” on Tuesday, October 17, 2017 from 8:30-9:25 a.m. PT.

    About Merus N.V.
    Merus is a clinical-stage immuno-oncology company developing innovative full-length human bispecific antibody therapeutics, referred to as Biclonics®. Biclonics®, which are based on the full-length IgG format, are manufactured using industry standard processes and have been observed in preclinical studies to have several of the same features of conventional monoclonal antibodies, such as long half-life and low immunogenicity. Merus’ lead bispecific antibody candidate, MCLA-128, is expected to begin a Phase 2 combination trial in the second half of 2017 in two metastatic breast cancer populations. MCLA-128 is also being evaluated in a Phase 1/2 clinical trial in Europe in gastric, ovarian, endometrial and non-small cell lung cancers. Merus’ second bispecific antibody candidate, MCLA-117, is being developed in a Phase 1 clinical trial in patients with acute myeloid leukemia. The Company also has a pipeline of proprietary bispecific antibody candidates in preclinical development, including MCLA-158, which is designed to bind to cancer stem cells and is being developed as a potential treatment for colorectal cancer and other solid tumors, as well as MCLA-145 designed to bind to PD-L1 and a non-disclosed second immunomodulatory target, which is being developed in collaboration with Incyte Corporation.

    Contacts:

    Media:
    Eliza Schleifstein
    +1 973 361 1546
    eliza@argotpartners.com

    Investors:
    Kimberly Minarovich
    +1 646 368 8014
    kimberly@argotpartners.com

    Merus N.V.
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