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Lancering Barhemsys H1 19 ?

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  1. [verwijderd] 16 november 2018 18:31
    quote:

    Elvisfan schreef op 16 november 2018 18:25:

    vandaag toch alweer veel rood .... Acacia, Celyad ... gelukkig nog GLPG en Argenx in bezit die de meubels redden

    Celyad hopelijk nu op zn laagste koers, toch vrees ik dat het nog lager kan; nieuws FDA is meer dan welkom
    Acacia is nu een puur speculatief aandeel geworden. Celyad moet toch maar beter vorderingen op de clinische trials rapporteren, met conferenties geraken ze niet verder.
  2. [verwijderd] 16 november 2018 18:52
    Pff, en daar is hij dan, de 2,15, de laagste koers ooit.
    Is ook niet verwonderlijk met Novo die dag in dag uit werkelijk onafgebroken de laat vol blijft duwen. Grote orders van boven de 10.000 of 15.000 stuks dus dat zijn geen particulieren, en gezien het recente afbouwen van Novo moeten zij dat dan wel zijn.

    Vlak voor half zes stonden we al op 2,15 en verscheen er opeens een laatorder van 57.000 stuks op 2,25. Denken die nou echt dat die nog worden opgeknabbeld in de naveiling? Nog niet misschien.

    Maar we zitten er maar mooi mee. In feite valt het mij nog mee dat het enorme aanbod de afgelopen weken is opgevangen rond de 2,25.
    Als Novo even kwaad wil zetten ze de koers zo een euro lager want ze hebben nog 5 miljoen stukken te gaan.
    Er zit voor mij niets anders op dan het allemaal maar gelaten over mij heen te laten gaan.

    Fijn weekend.
  3. [verwijderd] 16 november 2018 19:27
    ik kijk naar Euronext Acacia Pharma, en ik zie rond 17.40 u. ongeveer 18.000 stuks. in de laat.
    Waarschijnlijk doe ik iets fout. Kan U mij wegwijs maken met de juiste link.? Het dumpen van
    Novo Nordisk is mij wel een vraagteken; Dit is namelijk geen kleine speler in de bio-sector.
  4. Wil Helmus 19 november 2018 10:16
    Persbericht van 6 november:

    The CAPA has now been submitted to the FDA by the contract manufacturer. As a result of these efforts, Acacia Pharma has resubmitted the NDA for BARHEMSYS. Within 30 days of resubmission FDA will classify it as either Class 1 (review completed within two months of receipt) or Class 2 (review completed within six months of receipt). Further updates in relation to these events will be provided in due course.

    Uiterlijk 6 december bericht dus
  5. [verwijderd] 19 november 2018 10:27
    quote:

    Wil Helmus schreef op 19 november 2018 10:16:

    Persbericht van 6 november:

    The CAPA has now been submitted to the FDA by the contract manufacturer. As a result of these efforts, Acacia Pharma has resubmitted the NDA for BARHEMSYS. Within 30 days of resubmission FDA will classify it as either Class 1 (review completed within two months of receipt) or Class 2 (review completed within six months of receipt). Further updates in relation to these events will be provided in due course.

    Uiterlijk 6 december bericht dus
    Bedankt!
  6. [verwijderd] 19 november 2018 22:09
    quote:

    WALLET schreef op 16 november 2018 19:27:

    ik kijk naar Euronext Acacia Pharma, en ik zie rond 17.40 u. ongeveer 18.000 stuks. in de laat.
    Waarschijnlijk doe ik iets fout. Kan U mij wegwijs maken met de juiste link.? Het dumpen van
    Novo Nordisk is mij wel een vraagteken; Dit is namelijk geen kleine speler in de bio-sector.
    Geen fout.
    Ik kijk bij de Giro, zie dan direct de 5 bovenste laat en bied koersen. Bij Euronext is er 15 minuten vertraging.
    Dus wij kijken op een ander moment en dan kan die order er niet meer zijn of nog niet.

    Overigens ben ik niet de enige die dit ziet. Op beursig heeft iemand het zelfs over 80.000.

    beursig.com/forum/viewtopic.php?f=4&a...

    Ach, ooit stoppen ze of zijn ze er vanaf.
  7. [verwijderd] 21 november 2018 15:11
    Cambridge, UK and Indianapolis, US - 21 November 2018: Acacia Pharma Group plc ("Acacia Pharma", the "Company") (EURONEXT: ACPH) announces that data and analyses from its positive Phase 3 clinical trial of BARHEMSYS(TM) (intravenous amisulpride) as rescue treatment of established post-operative nausea & vomiting (PONV) have been published (Habib et al1) in the online edition of the leading peer-reviewed journal Anesthesiology, the official publication of the American Society of Anesthesiologists. Positive headline results were first announced by the Company in February 2017.
    Dr Ashraf Habib, Professor of Anesthesiology at Duke University School of Medicine and chief investigator of the study, said: "The key unmet need in PONV is the rescue of patients who develop nausea or vomiting, despite having received the current standard-of-care antiemetic prophylaxis. The results from this published Phase 3 trial are very encouraging as they showed that BARHEMSYS was effective at rescuing patients who had failed prophylaxis, without causing sedation. If approved, BARHEMSYS would offer physicians and patients a new option for the rescue treatment of PONV."
    A New Drug Application (NDA) for BARHEMSYS, including data from this and three other positive Phase 3 trials, is under review by the US Food and Drug Administration (FDA). The extensive clinical trial programme has studied the safety and efficacy of BARHEMSYS for investigational new uses in the treatment of established PONV, whether or not prior prophylaxis was given, and the prevention of PONV, alone or in combination with other antiemetics.
    Dr Gabriel Fox, Acacia Pharma's Chief Medical Officer, added: "About one-third of surgical patients who receive prophylactic antiemetics prior to surgery still go on to suffer from PONV and this represents an important challenge for the surgical team. This is especially the case as no other antiemetic has been shown in a prospective trial to be effective in that setting. If BARHEMSYS is approved by FDA for this indication, we believe it will become a valuable part of the antiemetic armamentarium and an important option for patients and physicians in the US."
    Reference
    Habib, A.S. et al. Amisulpride for the Rescue Treatment of Postoperative Nausea or Vomiting in Patients Failing Prophylaxis - A Randomized, Placebo-controlled Phase III Trial. Anesthesiology 2018, doi:10.1097/ALN.0000000000002509 [epub ahead of print]

    About PONV
    PONV is a common complication of surgery, occurring in approximately 30% of surgical patients and up to 80% of high-risk patients. It is associated with the use of anaesthetic gases and opioid pain-killers and is particularly common following gynaecological, abdominal, breast, eye and ear operations, especially those lasting an hour or more.
    The Company estimates that approximately 65 million surgical procedures are conducted in the US each year that require injectable analgesia and are eligible for antiemetic use to prevent PONV. Based on market research, Acacia Pharma estimates that the total market in the US for prophylactic and rescue treatment comprises an estimated 34 million treatment events annually.
    PONV has been ranked as the most undesirable of all surgical complications by patients and contributes significantly to patient anxiety and distress. PONV can delay hospital discharge; result in re-admission after in-patient procedures; and lead to day-case patients being admitted to hospital, all of which can result in significantly increased healthcare costs.
    About Acacia Pharma
    Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialisation of new nausea & vomiting treatments for surgical and cancer patients. The Group has identified important and commercially attractive unmet needs in nausea & vomiting and has discovered two product candidates based on the same active ingredient, amisulpride, to meet those needs.
    The Group's lead project, BARHEMSYS(TM) for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. A New Drug Application (NDA) for BARHEMSYS is under review by the US Food and Drug Administration (FDA). Its sister project, APD403 for chemotherapy induced nausea & vomiting (CINV), has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.
    Acacia Pharma is based in Cambridge, UK and its US operations are centred in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the under ISIN code GB00BYWF9Y76 and ticker symbol ACPH. www.acaciapharma.com
    Contacts
    Acacia Pharma Group plc
    Julian Gilbert, CEO
    Christine Soden, CFO
    +44 1223 919760
    IR@acaciapharma.com
    Citigate Dewe Rogerson (Financial PR)
    Mark Swallow, Shabnam Bashir, David Dible
    +44 20 7638 9571
    acaciapharma@citigatedewerogerson.com
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