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Aandeel VALERIO TX PSE:ALVIO.FR, FR0010095596

  • 0,118 16 apr 2024 09:21
  • -0,003 (-2,15%) Dagrange 0,118 - 0,120
  • 14.249 Gem. (3M) 107,7K

Onxeo 2016

218 Posts
Pagina: «« 1 ... 6 7 8 9 10 11 | Laatste | Omlaag ↓
  3. Omnius 8 maart 2017 09:42
    www.businesswire.com/news/home/201703...

    Onxeo: Full-year 2016 Results and Outlook for 2017
    Reinforcement of Onxeo’s strategic positioning in the development of innovative oncology treatments

    Acquisition of DNA Therapeutics and the AsiDNATM product, a first-in-class candidate in the new area of preventing tumor cells from repairing their DNA
    Enrolment for the phase III Livatag® study in advanced primary liver cancer completed on schedule to deliver preliminary results mid-2017
    Cash and cash equivalents of €29.2 million at December 31, 2016, providing financial visibility through to 2018.
  4. Omnius 11 mei 2017 13:34
    globenewswire.com/news-release/2017/0...

    Onxeo announces allowance of U.S. patent for Livatag® in hepatocellular carcinoma

    USPTO Notice of Allowance received for patent related to specific route of administration for Livatag® provides protection of related claims until 2032

    SharePrint
    May 10, 2017 13:17 ET | Source: Onxeo S.A.
    PARIS, May 10, 2017 (GLOBE NEWSWIRE) -- Onxeo S.A. (Euronext Paris:ONXEO) (NASDAQ Copenhagen:ONXEO), a clinical-stage biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application covering the specific route of administration for Livatag®, which is currently in a phase III clinical trial (ReLive) for the second-line treatment of hepatocellular carcinoma (primary liver cancer).

    Livatag® (doxorubicin Transdrug™) is based on an innovative technology allowing the formulation of doxorubicin (a chemotherapeutic agent) within nanoparticles composed of polyalkylcyanoacrylate, cyclodextrin, and poloxamer. This nanoparticle formulation provides new and promising properties, including overcoming the mechanisms of chemoresistance developed by tumor cells that affect the efficacy of chemotherapy agents.

    “The United States represents a significant target market for Livatag®. This new U.S. patent significantly strengthens our Livatag® intellectual property portfolio, and enhances the value of this late-stage product candidate. We look forward to the availability of data from our ReLive trial in mid-2017,” said Judith Greciet, CEO of Onxeo.

    The new patent provides protection of the associated claims in the U.S. until 2032, and is in addition to the previously issued patents for the same patent family in other major territories, such as Europe and Japan. An additional patent family has also been filed based on a specific composition of Livatag® nanoparticles that, if granted, would extend the patent protection of Livatag® to 2036.
  8. Laugh about it 24 mei 2017 21:49
    quote:

    peebee schreef op 24 mei 2017 09:19:

    en weer één positief DSMB... de 10e

    www.onxeo.com/en/onxeo-announces-10th...
    vanzelfsprekend zeer positieve referentie voor Onxeo (Livatag) vanuit onafhankelijke Europese raad.
    Ik kocht 2 weken geleden al bij op basis van gemiddeld gestegen volume en positieve nieuws flow.
    Kwestie van weken voor mijn gevoel dat koers hogere toppen gaat neer zetten.
    We zullen nog even geduld moeten hebben, heb dit er graag voor over!
  13. Omnius 26 mei 2017 10:52
    Dit is de enige info die ik kan vinden, een analisten rapport (via boursarama.com)
    www.boursorama.com/forum-onxeo-ex-bio...
    markt voor Livitag 800 Miljoen. Lijkt erop dat dit mensen wakker heeft gemaakt. Huidige market cap ca. 200 miljoen (na de stijging van vandaag)

    ONXEO
    Council
    Image: pics-investir.lesechos.com/images/btn...
    invest Booked subscriber ONXEO - FR0010095596 / Paris PEA SRD
    real time quotation PARIS - 05/25/17 - 17H 35mn 16s
    1, 87% 3,270 € (c)
    Buy Sell
    The right time to build on
    success
    COURSES
    NEWS
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    HISTORY
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    FORUM

    INVEST IR.FR | LE 26/05/17 AT 08:04 | UPDATED 26/05/17 At 08:47
    This biotech will soon know the results of a major interim study on its flagship product. Revenues are estimated at € 800 million in the future by an analyst firm in case of success.

    Image:
    https: // invest.
    Leechos.fr/medias/2017/05/25/1680006_1495718884_1657311-149060 4644-shutterstock-397168636-min_565x377p.jpg The right time to build on success | Photo credits: Shutterstock
    The right time to build on success | Photo credit: Shutterstock
    Analysis (Invest)
    Another milestone for Biotech Onxeo and its flagship product, Livatag, is an advanced form of liver cancer that has few therapeutic options. The former BioAlliance, which merged with the Danish Topotarget in 2014, obtained a tenth positive recommendation from the safety and monitoring committee (data safety monitoring board, an independent committee responsible for assessing safety every six months) A clinical study) for the ongoing phase III study for Livatag. No changes to the study were requested, nor was there any specific comment to be made by the committee.
    For Oddo Securities, "this announcement is obviously good news as it comes to reassure on the security profile of the product that was for some time problematic. Indeed, the DSMB decided in 2008 to suspend phase II of Livatag because of the acute respiratory side effects observed at the time in the patients. Onxeo has since solved this problem by developing a new system of administration that has drastically reduced these risks.
    " And this new tenth recommendation is all the more positive because it comes" a few weeks of a major catalyst in terms of news flow for Onxeo with the publication of the interim results of phase III for its most important assets Livatag, "Continues the research firm. In the model developed by Oddo, it is 800 million euros of income that is at stake if successful, which could be facilitated by the fact that it is an orphan disease, which very often increases The chances of homologation. By way of comparison, the market capitalization of Onxeo is only 154 million euros. These interim results are expected by mid-2017. The biotech has enough cash by then, more than 12 million euros, that is to say a fortnight of financial visibility.
    ADVERTISING

    At 3.28 euros, the share has climbed by 31% since the beginning of the year and rebounded by 65% ??compared to its historic low of just a year ago. But it was worth more than 11 euros in February 2014.

    DL

    The board
    The upside is very important in case of success. It is now or never that we must bet on good results of the interim study concerning Livatag. We position ourselves in this sense on a naturally speculative file.
    The course at the time of the advice: 3.27 €

    More about
    investir.lesechos.fr/actions/conseil-... r-un-succes-1680006. php # P3jtk41b8lxhMkDK.99 The share has climbed by 31% since the beginning of the year and rebounded by 65% ??compared to its historic low of just a year ago. But it was worth more than 11 euros in February 2014. DL The board The upside is very important in case of success. It is now or never that we must bet on good results of the interim study concerning Livatag. We position ourselves in this sense on a naturally speculative file. The course at the time of the advice: 3.27 € More about investir.lesechos.fr/actions/conseil-... r-un-succes-1680006. php # P3jtk41b8lxhMkDK.99 The share has climbed by 31% since the beginning of the year and rebounded by 65% ??compared to its historic low of just a year ago. But it was worth more than 11 euros in February 2014. DL The board The upside is very important in case of success. It is now or never that we must bet on good results of the interim study concerning Livatag. We position ourselves in this sense on a naturally speculative file. The course at the time of the advice: 3.27 € More about investir.lesechos.fr/actions/conseil-... r-un-succes-1680006. php # P3jtk41b8lxhMkDK.99 DL The board The upside is very important in case of success. It is now or never that we must bet on good results of the interim study concerning Livatag. We position ourselves in this sense on a naturally speculative file. The course at the time of the advice: 3.27 € More about investir.lesechos.fr/actions/conseil-... r-un-succes-1680006. php # P3jtk41b8lxhMkDK.99 DL The board The upside is very important in case of success. It is now or never that we must bet on good results of the interim study concerning Livatag. We position ourselves in this sense on a naturally speculative file. The course at the time of the advice: 3.27 € More about investir.lesechos.fr/actions/conseil-... r-un-succes-1680006. php # P3jtk41b8lxhMkDK.99
  16. Omnius 12 september 2017 12:15
    globenewswire.com/news-release/2017/0...

    PARIS, Sept. 11, 2017 (GLOBE NEWSWIRE) -- Onxeo S.A. (Euronext Paris:ONXEO) (NASDAQ Copenhagen:ONXEO), (“Onxeo” or the “Company”), a clinical-stage biotechnology company specializing in the development of innovative drugs for the treatment of orphan diseases, in particular in oncology, today announced top line results from the phase III ReLive trial of Livatag® (doxorubicine Transdrug™) in adult patients with unresectable hepatocellular carcinoma (HCC), intolerant to sorafenib or having progressed after a systemic therapy including sorafenib, when compared to best standard of care. The study did not meet its primary endpoint of improving survival over the comparative group.

    The major reason is an unexpected high survival in the comparative group. Indeed, the study was not placebo controlled and patients in the comparative group could receive other anticancer agents (including oxaliplatin, gemcitabine or tyrosine kinase inhibitors) which might explain the high survival rate of the control arm. Livatag®, as single agent, showed a similar effect as the one observed in that comparative group with active treatments. There was no difference in efficacy between the two arms (Livatag 20mg/m² and 30mg/m²).

    The overall safety and tolerability profile of Livatag® in ReLive was favorable with a fully manageable toxicity profile in both groups of Livatag (20mg/m² and 30mg/m²) including in those patients who underwent the longest treatment periods, over one year. The overall tolerability was comparable to the one observed in the comparative group.

    “The Relive study did not meet its primary endpoint, partly due to the high survival rate in the control arm, which was unprecedented except in the most recent phase III negative trial post Sorafenib in HCC. However, Livatag tends to show a similar level of efficacy as recently reported for regorafenib in second line, in a well preserved liver function population (Child– Pugh A), although both drugs cannot be compared due to the lack of assessment of both drugs in the same trial," commented Philippe Merle, MD, Professor in Hepatology (La Croix Rousse Hospital, Lyon, France) and Coordinating Investigator of the ReLive study. ”We want to thank all the investigators who have supported the completion of this large phase III trial as well as the patients and their families, and we are confident that they benefited in participating in the Relive study.”

    The monitoring of the patients still enrolled in the study will continue to completion expected in H1 2019.

    The analysis of predefined subgroups is ongoing and the main results from the ReLive study will be presented on at the upcoming 11th Annual Conference of the International Liver Cancer Association in Seoul, South Korea (ILCA 2017 - ilca2017.org).

    “Once the Relive data are fully analyzed, we will reinitiate licensing discussion with potential partners based on key study outcomes to define the best path forward,” said Judith Greciet, Chief Executive Officer of Onxeo. “As already announced, Onxeo will continue to advance its diversified pipeline of innovative assets in oncology. Refocusing our R&D activities on AsiDNA™ and Beleodaq® should extend our financial visibility until early 2020."

    About Hepatocellular Carcinoma, an aggressive form of primary liver cancer

    Hepatocellular carcinoma (HCC) or hepatocarcinoma is the most common of the primary liver cancers (85% to 90%). According to Globocan (2012 data), liver cancer is the 6th most common cancer in terms of incidence (782,000 new cases worldwide each year, 5.6% of all new cancer cases) with the 2nd highest mortality rate (95% lethality) after lung cancer. The major risk factors are infection by hepatitis viruses (B and C), overconsumption of alcohol and metabolic diseases, especially non-alcoholic steatohepatitis (NASH), a growing cause of cirrhosis and HCC.

    About ReLive Phase III trial

    This international, multicenter, randomized, comparative Phase 3 trial was conducted in 11 countries (Europe, USA, and MENA) at 70 centers and enrolled 397 adult patients with unresectable hepatocellular carcinoma (HCC), intolerant to sorafenib or having progressed after a systemic therapy including sorafenib. Patients were randomized to receive Livatag® administered intravenously for 6 hours every 4 weeks (n=263) or best standard of care, i.e. any cancer therapy chosen by the physician except sorafenib (n=134). Treatment was continued until disease progression or unacceptable toxicity. The monitoring of the patients enrolled in the study will continue to completion, expected Q1 2019.

    Upcoming events

    September 16, 2017 11th meeting of the International Liver Cancer Association
    Oral Presentation of ReLive Results Seoul, South Korea
    October 2nd, 2017 French Society of Financial Analysts meeting
    ReLive Results & Strategic Update Paris, France
    October 4-5, 2017 Large & MidCap Forum Paris, France
    October 19, 2017 Portzamparc Biotech Symposium Paris, France
    October 26, 2017 Q3 results and business update
  18. Omnius 28 september 2017 08:44
    www.onxeo.com/en/onxeo-announces-comp...

    Results demonstrate a very strong synergistic effect between AsiDNA™, first-in-class DNA break repair inhibitor (DBRi), and histone deacetylase inhibitors (HDACi)
    This synergy is particularly high for the combination of its two proprietary assets, AsiDNA™ and belinostat,
    Potential application of AsiDNA™ in combination with any HDACi fully covered by a key worldwide patent application

    Hopelijk kan de koers hierop weer wat herstellen.
218 Posts
Pagina: «« 1 ... 6 7 8 9 10 11 | Laatste |Omhoog ↑

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