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Lancering Barhemsys H1 19 ?
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madmen schreef op 24 april 2019 13:17 :
Kleine shakeout! Bijna zeker uitstekend nieuws nu! Zelfde bij Galapagos gezien. Nooit aandelen van gehad en dan dag voordien ingestapt tegen 85 om week later terug te verkopen aan 112. Vraag me soms echt af waarom een mens moet investeren in biotech. Gewoon wachten tot laatste dag en dan 90% kans dat je winst maakt na wat DD te hebben gedaan. Zal niet de laatste shakeout zijn. Koop wel alleen maar bij als de 3 terug raken want gemiddelde van 1.53 dus nog voldoende winst. Blijf in ieder geval zitten nu na deze actie tot na de goedkeuring. Uiteraard geen stop loss gezet. Denk dat er sommige hun aandelen plots kwijt zijn vandaag....
Klopt is afgegaan. Is dit een strategie denk je om de koers te drukken?
Das geen strategie da s gewoon het gevolg van het feit dat mensen stop losses zetten. Zeker bij volantiele aandelen zoals acacia kan dit een heuse waterval genereren. Dan is het gezond dat de beurstoezichter een halt roept. Er is weinig reden om de koers te drukken, een paar weken geleden kon je ze nog onder de 2 euro kopen.
Er zet er eentje een muurtje op 3.35
en de laat begint uit te drogen op dit niveau dus zou nog een leuke eindveiling kunnen worden
Sirlander schreef op 24 april 2019 17:05 :
ondertussen in het orderboekje
www.euronext.com/en/products/equities... Wat een dag was dit. Hoop dat morgen meer goeds brengt haha. Behoorlijke vraag van 45k stuks :)
pijnlijk voor degene die ernaast gegrepen hebben vandaag
Bij de vorige keer kort voor de (niet) goedkeuring heeft de dip een paar dagemn aangehouden. Ik hoop van niet maar vermoedt wel dat er morgen nog koopkansen komen.
inderdaad, maar nu is er wel wat meer zekerheid en er staat ten laatste 5/05... dus kan vroeger (nog 7 beursdagen) wachten ze nog met in te stappen of nemen ze het risico niet? Ik moet wel constateren dat ook in dit aandeel de kleine belegger niets te zeggen heeft. De beurs wordt gespeeld door de big guys...gevaarlijk spel.
Ik denk dat er toen 0% twijfel was. De ceo had zelfs in de krant gezegd dat hij de ipo voor de goedkeuring deed zodat de aandeelhours een centje konden meepikken...
Dus gewoon vasthouden....
Vandaag ook nog wat geld vrijgemaakt. Kon de verleiding niet weerstaan. Nog een pluk voor 3.40 gekocht. Daar moeten we toch boven komen na goedkeuring lijkt me zo. Mocht het verder dalen koop ik nog wat bij
Mopperaar schreef op 24 april 2019 18:16 :
Bij de vorige keer kort voor de (niet) goedkeuring heeft de dip een paar dagemn aangehouden. Ik hoop van niet maar vermoedt wel dat er morgen nog koopkansen komen.
die koopkansen kunnen zeker komen Mopperaar; (ik spreek vr mezelf) ik laat me niet gekmaken; ik hou vast tot 5 Mei, wat er tssin gebeurt, is op zich niet belangrijk; ik wil die goedkeuring zien !! velen hebben reeds een mooie winst behaald en winstnemers in dit soort aandelen heb je altijd, kijk nr het koersverloop vandaag .... even uitzweten :-)
Correctie op mijn vorige post... Nog 6 beursdagen (1/05 gesloten) voor ultimatum 05/05.
Cambridge, UK and Indianapolis, US – 25 April 2019: Acacia Pharma Group plc (“Acacia Pharma”, the “Company”) (EURONEXT: ACPH) announces that additional data and analyses from its positive Phase 3 clinical trial of BARHEMSYS® (intravenous amisulpride) as a rescue treatment of established post-operative nausea & vomiting (PONV) will be presented today in a poster at the 2019 Annual Congress of Enhanced Recovery and Perioperative Medicine in Washington, DC (25-27 April 2019). Primary study data were previously published (online-first in 2018) by Habib et al. in Anesthesiology (Ref. 1) The Phase 3 rescue treatment trial compared a single 5 or 10 mg dose of BARHEMSYS, a dopamine D2/D3 antagonist antiemetic, against placebo in patients with established nausea and/or vomiting after surgery, who had previously received prophylactic antiemetics. The double-blind study randomised 702 adult patients and was the first major study to investigate rescue with a different mechanistic class of antiemetic. The primary endpoint was the successful resolution of the episode of PONV (no recurrence of vomiting or requirement for further antiemetic rescue) for the 24-hour period after rescue treatment: termed a complete response. The conclusion of the study was that a single 10 mg dose of BARHEMSYS was statistically significantly more effective than placebo for the rescue treatment of PONV (complete response rate 42% vs 29%, p=0.006). Additional post-hoc analysis has shown a similar efficacy benefit for BARHEMSYS regardless of the number of antiemetics that had been given as prior prophylaxis; and that the proportion of patients achieving treatment success with BARHEMSYS 10 mg reduces as the number of baseline PONV risk factors increases. The proportion of patients with one or more adverse events was slightly lower in the group receiving 10 mg BARHEMSYS (43.0%) than placebo (48.1%). The only adverse events occurring in at least 5% of patients in either group were nausea 24 hours or more after treatment (12% with BARHEMSYS 10 mg vs 13% with placebo), flatulence (6% vs 8%), constipation (5% vs 7%), vomiting 24 hours or more after treatment (4% vs 6%), headache (4% vs 7%), infusion site pain (5% vs 4%) and pruritus (4% vs 6%). 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) with a target action date of 5 May 2019. 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 of a different class. Details of the poster presentation are: Abstract title: Amisulpride for the Rescue Treatment of Postoperative Nausea and Vomiting in High-Risk Patients who failed Prophylaxis: Impact of Risk Factors and Number of Prophylactic Agents on Treatment Success Authors: Ayad, S., Elsharkawy, H., Bichajian, L., Ashburn, C., Fox, G., and Habib, A. Date/time: Thursday 25 April, 17:30-19:00 Eastern Time 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 2019;130(2):203-212. 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 9571acaciapharma@citigatedewerogerson.com 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. PONV has been ranked as the most undesirable of all surgical complications in some patient surveys. Acacia Pharma estimates that approximately 65 million surgical procedures are conducted in the US each year that are eligible for antiemetic use to prevent PONV. Based on market research, Acacia Pharma estimates that the total market in the US for high risk prophylactic and rescue treatment comprises an estimated 34 million patients annually. 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® 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 Forward looking statement This announcement includes forward-looking statements, which are based on current expectations and projections about future events. These statements may include, without limitation, any statements preceded by, followed by or including words such as "believe", "expect", "intend", "may", "plan", "will", "should", "could" and other words and terms of similar meaning or the negative thereof. Forward-looking statements may and often do differ materially from actual results. These forward-looking statements are subject to risks, uncertainties and assumptions about the Company and its subsidiaries and investments, including, among other things, the development of its business, trends in its operating industry, and future capital expenditures and acquisitions. By their nature, forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. Any forward-looking statements reflect the Company's current view with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to the Group's business, results of operations, financial position, prospectus, growth or strategies and the industry in which it operates. Save as required by law or applicable regulation, the Company and its affiliates expressly disclaim any obligation or undertaking to update, review or revise any forward-looking statement contained in this announcement whether as a result of new information, future developments or otherwise. Forward-looking statements speak only as of the date they are made.
Toen ik de mail zag dacht ik éven dat de goedkeuring er vandaag was gekomen.
Target date nog steeds 5 mei. Dacht dat daar de goedkeuring was helaas nog ff wachten.
Zelfde gevoel hier. Geduld.
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