US launch is planned for 2H 2020APD403 (intravenous and oral amisulpride), a selective dopamine antagonist 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.
Acacia Pharma’s rights to further develop and commercialize BYFAVO are in-licensed from Paion UK Limited pursuant to an assignment from Cosmo Technologies Limited for the US market.
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 July 2020: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), announces that the US Food and Drug Administration (FDA) has approved of a second supplier for the active pharmaceutical ingredient (API) for BARHEMSYS® (amisulpride injection).
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The Company has identified important and commercially attractive unmet needs in these areas that its product portfolio aims to address.Acacia Pharma’s first product, BARHEMSYS® (amisulpride injection) for postoperative nausea & vomiting (PONV), has been approved by the US FDA, with US launch planned for 2H 2020.BYFAVO™ (remimazolam) for injection, a very rapid onset/offset IV benzodiazepine sedative is approved in the US for use during invasive medical procedures in adults lasting 30 minutes or less, such as colonoscopy and bronchoscopy. By their nature, forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. The Company has identified important and commercially attractive unmet needs in these areas that its product portfolio aims to address.BYFAVO™ (remimazolam) for injection, a very rapid onset/offset IV benzodiazepine sedative is approved in the US for use during invasive medical procedures in adults lasting 30 minutes or less, such as colonoscopy and bronchoscopy.
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Classification Financial Instrument. Cambridge, UK and Indianapolis, US – 27 July 2020: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), announces that …
• ByFavo™ sub-licensed to Acacia Pharma Group (EURONEXT: ACPH) in January in equity for product deal for €30m in upfront payment, regulatory and commercial milestones due in equity plus up to $105m in sales related commercial milestones. Markt Euronext Brussels. The Company anticipates the approval of a second supplier will support its ability to provide a continuous, high-quality product supply to meet the anticipated ongoing demand.“We are very pleased to have received approval from the FDA for our second supplier of API for BARHEMSYS as we continue to make good progress with our preparations for its US launch,” 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.
This category only includes cookies that ensures basic functionalities and security features of the website. These cookies will be stored in your browser only with your consent. “We believe there will be strong demand for BARHEMSYS as US healthcare institutions seek to address surgical backlogs created by the Coronavirus crisis.
Novel medicine to support cancer therapy IPO MAR 2018 (EURONEXT: ACPH.BR (~9X)) Biotech . 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. Cambridge, UK and Indianapolis, US – 16 July 2020: Acacia Pharma Group plc (the "Company”) (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on … Forward looking statement You also have the option to opt-out of these cookies. 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.
Cambridge, UK and Indianapolis, US – 28 January 2019: Acacia Pharma Group plc (“Acacia Pharma”, the “Company”) (EURONEXT: ACPH) welcomes an editorial published in the leading peer-reviewed journal Anesthesiology, accompanying the print publication of results from its positive Phase 3 clinical trial of BARHEMSYS™ (intravenous amisulpride) as rescue treatment of established …
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