Press releases archive
Circassia to Exercise Option for Full US Commercial Rights to COPD Treatment Tudorza® from AstraZeneca
Oxford, UK – 11 December 2018: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces it has issued a notice of option exercise to AstraZeneca to acquire the full US…
Interim Results for the Six Months Ended 30 June 2018
– NIOX® sales growth continued – – Tudorza® profit share revenues increased – – Duaklir® NDA and Tudorza® sNDA accepted for review by FDA – – China commercial expansion on track – – AstraZeneca equity stake increased – Oxford, UK…
Circassia Announces Duaklir® New Drug Application (NDA) and Tudorza® Supplemental NDA Accepted for Review by FDA
– PDUFA target action date of 31 March 2019 confirmed for both filings – Oxford, UK – 13 August 2018: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces that the…
Circassia Announces Submission of Duaklir® New Drug Application and Tudorza® Supplemental New Drug Application in the United States
– Duaklir® NDA for treatment of chronic obstructive pulmonary disease (COPD) – – Tudorza® sNDA for inclusion of COPD exacerbation reduction and cardiovascular safety data in label – Oxford, UK – 1 June 2018: Circassia Pharmaceuticals plc (“Circassia” or “the…
Circassia Announces Positive Data Presented at 2018 American Thoracic Society Conference from Tudorza® Phase IV and Duaklir® Phase III Studies
Oxford, UK – 22 May 2018: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the presentation of positive clinical data from the Tudorza® Pressair® phase IV ASCENT study and…
Preliminary Results for the Year Ended 31 December 2017
– Strong NIOX® sales growth – – Good progress in AstraZeneca US commercial partnership – – Compelling clinical data for Tudorza® and Duaklir® – – Commercial platform expansion in US and China – – Refocused investment strategy to support commercial…
Circassia Receives Innovative Technology Contract from Vizient, Inc. for NIOX VERO® Asthma Management Products
Oxford, UK – 8 February 2018: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces that it has received a multi-year Innovative Technology contract for its NIOX VERO® asthma management…
Circassia Announces Tudorza® Successfully Met Both Primary Endpoints in ASCENT Phase IV Study in Chronic Obstructive Pulmonary Disease
– Significantly reduced COPD exacerbations – – Demonstrated favourable cardiovascular safety profile similar to placebo – – Circassia’s partner AstraZeneca plans to file data for inclusion in US label – Oxford, UK – 4 December 2017: Circassia Pharmaceuticals plc (“Circassia”…
Circassia Welcomes New NICE Guidelines Recommending Use of FeNO Testing in Asthma Diagnosis
Oxford, UK – 29 November 2017: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, welcomes the publication of new clinical guidelines by the UK’s National Institute for Health and Care Excellence…
Interim Results for the Six Months Ended 30 June 2017
– Strong NIOX® sales growth – – Duaklir® NDA filing on track following positive phase III results – – AstraZeneca US commercial collaboration progressing well – – Respiratory pipeline advancing – Oxford, UK – 27 September 2017: Circassia Pharmaceuticals plc…
Circassia Announces European Launch of NIOX VERO® Nasal Mode for Screening of Primary Ciliary Dyskinesia
Oxford, UK – 12 September 2017: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty pharmaceutical company focused on respiratory disease, today announces the European launch of the NIOX VERO® nasal application for the screening of primary ciliary…
Circassia Announces Duaklir® Successfully Met Primary Endpoints in AMPLIFY Phase III Study in Chronic Obstructive Pulmonary Disease
– NDA submission planned H1 2018 by partner AstraZeneca – – Filing supported by positive results from ACHIEVE dose-ranging study – – Circassia has exclusive commercialisation rights to Duaklir® in the United States – Oxford, UK – 7 September 2017:…
Preliminary Results for the Year Ended 31 December 2016
– Transformational transaction with AstraZeneca for US commercial rights to two COPD products – – Leverages commercial infrastructure established as key growth platform – – Robust NIOX® sales growth – – Broad respiratory pipeline progressing – – Allergy investment halted…
Circassia Announces Top-Line Results from House Dust Mite Allergy Field Study
– Primary endpoint not achieved – – Treatment groups had greatly reduced Combined Score and symptoms – – Strong placebo effect mirrored previous cat allergy study – – Allergy investment halted – – Circassia to focus on broader respiratory business…
Completion of the Transaction and admission to trading on the London Stock Exchange
12 April 2017 THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN, INTO OR FROM THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR SOUTH AFRICA OR ANY…
Proposed Collaboration and Securing of Certain U.S. Commercial Rights to Tudorza® and Duaklir® from AstraZeneca
17 March 2017 THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN, INTO OR FROM THE UNITED STATES, CANADA, AUSTRALIA, JAPAN OR SOUTH AFRICA OR ANY…
Interim Results for the Six Months Ended 30 June 2016
– Strong NIOX® sales growth; respiratory pipeline progressing – – Unexpected phase III allergy results; Spring 2017 house dust mite results will inform allergy approach – – Commercial infrastructure expanded as strategic growth platform – – Robust portfolio strategy; early…
Circassia Announces Top-Line Results from Cat Allergy Phase III Study
– Primary endpoint not achieved – – Treatment groups had dramatically reduced Combined Score and symptoms – – Powerful placebo response eliminated ability to identify treatment effect – – Wider NIOX® and respiratory franchises unaffected by results – Oxford, UK…
Preliminary Results for the Year Ended 31 December 2015
– Positioned to deliver – – Cat allergy phase III study on track to report Q2 2016 – – Acquisitions validated; strong NIOX® sales growth and lead asthma product approved – – Fully funded; successful £275 million fundraising completed June…
Circassia Announces Positive Outcome of European Decentralised Procedure for Approval of Its Fluticasone Propionate Equivalent of GSK’s FLIXOTIDE® pMDI
– Product approvable in all reference product strengths – – Successful application based on in vitro demonstration of therapeutic equivalence – Oxford, UK – 24 November 2015: Circassia Pharmaceuticals plc (LSE: CIR) today announces the positive outcome of the European…
Circassia Business Update
— Good clinical progress across whole allergy and respiratory portfolio — — Strong commercial progress with significant NIOX® sales growth — — Robust balance sheet to fund delivery of pipeline — Oxford, UK – 27 October 2015: Circassia Pharmaceuticals plc…
Interim Results for the Six Months Ended 30 June 2015
– Clinical programs on track – – Cat allergy phase III to report H1 2016; recruitment for grass allergy phase III to start H1 2016 – – Acquisitions accelerate commercialization strategy and broaden portfolio – – Successful £275 million fundraising…
Circassia’s Extended Offer Period for Aerocrine has Increased Acceptances to 97.2 Percent
THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED IN IT IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA EXCEPT IN CERTAIN…
Completion of Acquisition of Prosonix Limited
THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED IN IT IS RESTRICTED AND IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA EXCEPT IN CERTAIN…
Proposed Acquisitions of Aerocrine AB and Prosonix Limited Creating a World-Class Allergy and Asthma Specialty Pharma Business
NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES THIS ANNOUNCEMENT AND THE INFORMATION CONTAINED HEREIN IS RESTRICTED AND NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA,…
Preliminary Results for the Year Ended 31 December 2014
– Strong clinical progress; Cat-SPIRE phase III study fully recruited – – Robust financial position; fully-funded to bring Cat-SPIRE to market – – Commercialisation preparations underway; infrastructure build advancing – Oxford, UK – 26 February 2015: Circassia Pharmaceuticals plc (“Circassia”…
Circassia Interim Management Statement
– Strong operational progress; clinical programmes on track – – Encouraging results from third season follow-up study in grass allergy – Oxford, UK – 11 November 2014: Circassia Pharmaceuticals plc (“Circassia” or “the Company”; LSE: CIR), a specialty biopharmaceutical company…
Interim Results for the Six Months Ended 30 June 2014
— Successfully raised over £200 million in landmark IPO — — Fully-funded to bring to market the first of a new generation of allergy immunotherapies — — Strong operational momentum and Cat-SPIRE phase III study >85% recruited — Oxford, UK…
Circassia Announces Results from House Dust Mite Allergy Treatment Phase IIb Two-Year Follow-up Study
Oxford, UK – 13 June 2014: Circassia Pharmaceuticals plc (“Circassia” or “the Company”) (LSE: CIR), a clinical-stage specialty biopharmaceutical company, today announces positive top-line results from a two-year follow-up of a phase IIb clinical study of HDM-SPIRE, a house dust…
Notice of Interim Results
Oxford, UK – 3 June 2014: Circassia Pharmaceuticals plc (“Circassia” or “the Company”) (LSE: CIR), a clinical-stage specialty biopharmaceutical company, will be announcing its interim results for the six months ended 30 June 2014 on Tuesday 29 July 2014. An…
Interim management statement
Oxford, UK – 19 May 2014: Circassia Pharmaceuticals plc (“Circassia” or “the Company”) (LSE: CIR), a clinical-stage specialty biopharmaceutical company, today publishes its interim management statement for the period from 1 January to 18 May 2014. OPERATIONAL HIGHLIGHTS Cat-SPIRE •…