Acacia Pharma 2020

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Sweetheart
0
quote:

Diedelie schreef op 26 februari 2020 23:26:


Ik hoop dat het niet is zoals bij Mithra, als er goed nieuws is dan zakt de koers daar altijd !! Ik hoop dat dit hier niet het geval is....


Veel stress en risiko s zijn nu uit dit aandeel, dus als het nu niet over de 4-gaat in afzienbare tijd,..
ulyss
0
quote:

Dongen schreef op 26 februari 2020 23:38:


[...]het ging over n volgend bericht volgende week mbt byfavo dus ik begrijp deze reactie niet


ok fout begrepen. Al teveel Dom Perignon achter de kiezen na 9 maanden stress na second refusal, maar dit forum was/is super . Veel bijgeleerd en dank aan jullie
Biobert
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Zojuist heb ik mevrouw Christine Solden gefeliciteerd met het succes. Zij mailde me terug: we are all delighted.
brightlight
0
Dikke proficiat aan alle volhouders. het was niet altijd even makkelijk, maar uiteindelijk hebben we de meest logische uitkomst.
Wat betreft de koers: het afgelopen jaar was de hoogste koers 3.99 Euro ZONDER goedkeuring. Dit moeten we moeiteloos kunnen halen in de volgende dagen. Op termijn en op basis van de peak sales en de geprojecteerde winstmarges, gesteld dat die gerealiseerd kunnen worden, zie ik dit aandeel vertienvoudigen, maar dat is natuurlijk niet voor morgen. Ik verwacht morgen of de komende dagen wel een flinke koerdoel verhoging van Bank De Groof en RBC Capital management. Hun doelen staan nu op respectievelijk 4.80 en 4.40.
WARREN BUFFET2030
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Eindelijk, dat werd tijd, nu op naar 5 april en het verwachte koersdoel van 13.8;)
Aquila84
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indianrider
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Super opgepast tigenix ging na goedkeuring omlaag om na een paar weken en bod te krijgen voor overname
Rikske68
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[quote alias=Börs id=12156934 date=202002262224]
[...]
Hopelijk geen spijt?
[/quote
Nooit spijt na winst,heb er nog steeds een 1000tal,dus laat maar komen.
KareltjeBio
0
Proficiat allen! En nu niet allemaal gelijk naar de uitgang rennen....koers moet omhoog :-)
KareltjeBio
0
quote:

Elvisfan schreef op 27 februari 2020 06:33:


blijkbaar approval binnen?

vreemd dat er niets op hun site vermeld staat

www.acaciapharma.com/news/category/pr...




PR afdeling hing in de kroeg....
Elvisfan
0
quote:

KareltjeBio schreef op 27 februari 2020 06:35:


[...]

PR afdeling hing in de kroeg....


blijkbaar ... alleen spijtig dat het beurssentiment niet te best is; afwachten dus

Ontop1
0
quote:

Elvisfan schreef op 27 februari 2020 06:37:


[...]

blijkbaar ... alleen spijtig dat het beurssentiment niet te best is; afwachten dus



Hopelijk met Byfo is het sentiment dan beter
Nurfer
0
Daarnet is er een persbericht door acacia uitgestuurd met de bevestiging van de FDA-goedkeuring. En nu die koers de lucht in !
Endless
0
BARHEMSYS is the first and only antiemetic to be approved for the rescue treatment of PONV in patients who have failed prior prophylaxis using current standard of care1,2

An estimated 16 million surgical patients each year in the US suffer from PONV despite receiving prophylaxis3

BARHEMSYS is also approved for the prevention of PONV, either alone or in combination with an antiemetic of a different class

Conference call scheduled for 10:00 am CET, Thursday 27 February

This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.

Cambridge, UK and Indianapolis, US – 27 February 2020: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer chemotherapy, announces that the US Food and Drug Administration (FDA) has approved BARHEMSYS® (amisulpride injection) for the prevention and treatment of PONV in adult patients.

“The approval of our first product represents a significant milestone in Acacia Pharma’s evolution into an integrated hospital pharmaceutical company with strong development and commercialization capabilities,” commented Mike Bolinder, Acacia Pharma’s CEO. “I would like to thank the Acacia Pharma team and stakeholders that have delivered this new treatment option for the millions of adult surgical patients each year suffering from, or at risk of, PONV. Our goal is for BARHEMSYS to become established as the new standard of care in the US for the treatment of PONV in patients who have failed standard prophylaxis, the area of highest unmet need. The results of our extensive clinical program also allow us to offer BARHEMSYS as an option for the prevention of PONV in higher-risk patients and settings, where combination prophylaxis can be valuable. We are on target with our commercial preparations and expect to launch BARHEMSYS in the second half of this year.”

Professor TJ Gan, Chairman of the Department of Anesthesiology at Stony Brook University in New York, said: “PONV remains a major problem for surgical patients and there have been few therapeutic advances over the past 20 years. It is often considered by patients to be the most undesirable complication of surgery, even worse than pain. It is therefore very welcome to be able to add BARHEMSYS to the treatment arsenal, especially for rescue treatment of patients failing standard prophylaxis, where we previously had no approved agent.”

“We are delighted that BARHEMSYS has gained FDA approval,” said Acacia Pharma’s Chief Medical Officer, Dr. Gabriel Fox. “BARHEMSYS demonstrated significant benefits in the treatment and prevention of PONV in four pivotal trials. We are grateful to all the clinical investigators, hospital staff and, above all, patients who have made this approval possible through their participation in our clinical development program.”

BARHEMSYS is an intravenous formulation of the selective dopamine D2 and D3 antagonist amisulpride (2.5 mg/mL). The New Drug Application (NDA) submitted by Acacia Pharma for BARHEMSYS, which included four positive Phase 3 studies, contained data gathered from more than 3,300 surgical patients and healthy volunteers. The approval for BARHEMSYS covers the treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis and the prevention of PONV, either alone or in combination with an antiemetic of a different class.

The Company owns global rights to BARHEMSYS and intends to directly commercialize the product in the US through its own sales channel, having built critical sales, marketing, medical, and operational infrastructure and capabilities over the past two years. The Company plans to launch BARHEMSYS in 2H 2020.

In a randomized, double-blind, placebo-controlled study involving patients who had failed the most commonly used antiemetic prophylaxis, a single 10 mg dose of BARHEMSYS (n=230) was significantly more effective than placebo (n=235) at treating patients (42% vs 29%; p=0.003).1 In a double-blind, randomized, placebo-controlled study in patients at the highest risk of suffering from PONV (Apfel score 3 or 4), a single 5 mg dose of BARHEMSYS in combination with another antiemetic (n=572) significantly improved protection from PONV compared to placebo plus another antiemetic (n=575; 58% vs 47%; p<0.001).4

The most common side effects observed across the four pivotal studies, reported in at least 2% of adult patients who received BARHEMSYS and at a higher rate than placebo were: infusion site pain (6% vs 4% with placebo), chills (4% vs 3%), hypokalemia (4% vs 2%), procedural hypotension (3% vs 2%), and abdominal distension (2% vs 1%). Serum prolactin concentrations were measured in one prophylaxis study where 5% (9/176) of BARHEMSYS-treated patients had increased blood prolactin reported as an adverse reaction compared to 1% (1/166) of placebo-treated patients.

Acacia Pharma’s second product, Byfavo™ (remimazolam injection), was recently in-licensed from Cosmo Pharmaceuticals NV and an NDA is currently under review by FDA for use in procedural sedation in adults. The application has a target PDUFA action date of 5 April 2020. Subject to approval, the Company also intends to launch Byfavo in the US during 2020 and to commercialize Byfavo using the same sales and marketing infrastructure.

Conference Call Information

The Acacia Pharma management team will host a conference call today, Thursday 27 February 2020, at 10:00 am CET (09:00 am GMT).

Please join the event conference 5-10 minutes prior to the start using the password Acacia Pharma and any of the phone numbers provided below.

Password: Acacia Pharma
Sirlander
0
acaciapharma.com/news/2020/02/acacia-...

eindelijk de verlossende boodschap!
was een lang ritje maar een leerrijk ritje.
Geduld wordt beloond. Logische denken en soms een beetje staal in de bolas kan helpen. Even genieten van deze overwinning en dan op zoek naar de volgende parel ;)






Endless
0
Cambridge, UK and Indianapolis, US – 27 February 2020: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer chemotherapy, will announce its results for the full year ended 31 December 2019 on Monday 2 March 2020. The Company’s Annual Report will be available on the Company’s website www.acaciapharma.com in the Investors/Financial Reports section on Tuesday 3 March 2020.

The Company also notes that its annual general meeting of shareholders (“AGM”) will be held at 11.00 am BST on Tuesday 7 April 2020 at the offices of Stephenson Harwood LLP, 1 Finsbury Circus, London EC2M 7SH, UK.

Contacts

Acacia Pharma Group plc
Mike Bolinder, CEO
+44 1223 919760
IR@acaciapharma.com

Citigate Dewe Rogerson (Financial PR)
Mark Swallow, Frazer Hall, David Dible
+44 20 7638 9571
acaciapharma@citigatedewerogerson.com

About Acacia Pharma

Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer chemotherapy. The Company has identified important and commercially attractive unmet needs in these areas that its product pipeline aims to address.

Acacia Pharma’s lead product, BARHEMSYS® for postoperative nausea and vomiting (PONV), has been approved by the US FDA, with US launch planned for 2H 2020.

Byfavo™ (remimazolam injection), an ultra-short-acting and reversible sedative/anesthetic investigated for use during invasive medical procedures, such as colonoscopy and bronchoscopy, is in-licensed from Cosmo Pharmaceuticals NV for the US market. The NDA for Byfavo has been filed with the US FDA, and the target PDUFA action date is 5 April 2020.

APD403 (intravenous and oral amisulpride), a selective dopamine antagonist for chemotherapy-induced nausea and 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 centered in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH.

www.acaciapharma.com



Blackice
0
quote:

Sirlander schreef op 27 februari 2020 07:10:


acaciapharma.com/news/2020/02/acacia-...

eindelijk de verlossende boodschap!
was een lang ritje maar een leerrijk ritje.
Geduld wordt beloond. Logische denken en soms een beetje staal in de bolas kan helpen. Even genieten van deze overwinning en dan op zoek naar de volgende parel ;)


Laat maar weten als je zo een parel gevonden hebt :)

Proficiat aan de blijvers!
Dit is hopelijk nog niet het einde. Op naar 5 april. :)
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