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The CALLA Phase III trial for AstraZeneca's Imfinzi (durvalumab) given concurrently with chemoradiotherapy (CRT) did not achieve statistical significance for the primary endpoint of improving progression-free survival (PFS) versus CRT alone in the treatment of patients with locally advanced cervical cancer.
AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination, has been granted marketing authorisation in the European Union (EU) for the pre-exposure prophylaxis (prevention) of COVID-19 in a broad population of adults and adolescents aged 12 years and older weighing at least 40 kg.
The approval by the European Commission was based on results from the Evusheld clinical development programme, including data from the PROVENT Phase III pre-exposure prophylaxis trial which showed a 77% reduction in the risk of developing symptomatic COVID-19 compared to placebo at the primary analysis and an 83% reduction at a six-month median analysis, with protection from the virus lasting at least six months.1-3Evusheld was generally well-tolerated in the trial.1-3
Ondexxya (andexanet alfa) has been approved in Japan for patients treated with the Factor Xa (FXa) inhibitors apixaban, rivaroxaban or edoxaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
The approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the ANNEXA-4 Phase III clinical trial showing Ondexxya rapidly and markedly reversed anti-FXa activity in patients with acute major bleeding.
Dod101 wrote:It pleases me to see that since the share price broke through £100 it has kept going and I note this morning that is now over £106. Long may that continue.
Dod
AstraZeneca and Daiichi Sankyo have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the US with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have a HER2 (ERBB2) mutation and who have received a prior systemic therapy. The application has also been granted Priority Review.
AstraZeneca's Biologics License Application (BLA) for tremelimumab has been accepted for Priority Review in the US, supporting the indication of a single priming dose of the anti-CTLA4 antibody added to Imfinzi (durvalumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC). A supplemental BLA (sBLA) has also been submitted for Imfinzi in this indication. This novel dose and schedule of the combination is called the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab).
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy. Patients with hormone receptor (HR) positive breast cancer should additionally have received or be ineligible for endocrine therapy.
Ultomiris (ravulizumab-cwvz) has been approved in the US for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive, which represents 80% of people living with the disease.1-5
The approval by the Food and Drug Administration (FDA) was based on positive results from the CHAMPION-MG Phase III trial, in which Ultomiris was superior to placebo in the primary endpoint of change from baseline in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL) total score at Week 26, a patient-reported scale that assesses patients' abilities to perform daily activities.1
This FDA action marks the first and only approval for a long-acting C5 complement inhibitor for the treatment of gMG.
Pascal Soriot, Chief Executive Officer, commenting on the results said:
“2022 has started strongly for AstraZeneca. Farxiga achieved $1bn revenue in the quarter and our Oncology medicines delivered Product Sales growth of 18%, despite COVID-19 continuing to impact cancer diagnosis and treatment. High-level results from the DESTINY-Breast04 trial pointed to Enhertu’s potential to redefine treatment of HER2-low metastatic breast cancer, and Ultomiris became the first and only long-acting C5 inhibitor approved for generalised myasthenia gravis in the US.
Today we have unveiled plans for a new strategic research and development centre in the heart of Cambridge, Massachusetts’ scientific hub. In line with our sustainability commitments, it will be designed to the highest environmental standards. Our investments in pioneering science give us confidence of further advances in the years to come.”
Financial performance (growth numbers at CER)
‒ Total Revenue increased 60% to $11,390m, reflecting growth across the Company, the contribution of the
Alexion medicines and several Vaxzevria contracts that are expected to complete delivery by half year 2022
‒ Total Revenue from Oncology increased 25%7
, including a milestone payment; Product Sales from
Oncology increased 18%. Total Revenue from CVRM8
increased 18%, R&I9
increased 4% and Rare
Disease increased 7%10
‒ Operating Margin in the quarter benefitted from phasing of costs
‒ Core EPS increased 20% to $1.89
‒ FY 2022 guidance at CER reiterated
Key milestones achieved since the prior results
‒ Key data: Enhertu11 in HER212-low breast cancer (DESTINY-Breast04), AZD8233 in hypercholesterolaemia
(ETESIAN, Phase IIb) and publication of data for Lynparza in prostate cancer (PROpel) and nirsevimab in
RSV13 (MELODY/MEDLEY)
‒ Key approvals: Saphnelo and Evusheld in the EU, Ondexxya in Japan, and in the US, approvals of Ultomiris
for gMG14 and Lynparza15 for early breast cancer (OlympiA)
‒ Other key milestones: US FDA16 Breakthrough Therapy Designation for Enhertu in HER2-low breast cancer
(DESTINY-Breast04), Priority Reviews for Enhertu in HER2-mutant metastatic non-small cell lung cancer
(DESTINY-Lung01), and Imfinzi and tremelimumab in advanced liver cancer (HIMALAYA), and EMA17
accelerated assessment for nirsevimab in RSV (MELODY/MEDLEY)
And later;
Financial calendar
Announcement of half year and second quarter results 29 July 2022
Announcement of year to date and third quarter results 10 November 2022
Announcement of full year and fourth quarter results 9 February 2023 (tentative)
Dividends are normally be paid as follows:
First interim: Announced with the half-year and second-quarter results and paid in September
Second interim: Announced with full-year and fourth-quarter results and paid in March
The record date for the first interim dividend for 2022, payable on 12 September 2022, will be 12 August 2022.
The ex-dividend date will be 11 August 2022.
AstraZeneca today announced plans to open a new site at the heart of the Cambridge, MA , life sciences and innovation hub.
The new site will be a strategic R&D centre for AstraZeneca, as well as Alexion's new corporate headquarters. The site will bring together approximately 1,500 R&D, commercial and corporate colleagues into a single purpose-built space in Kendall Square, Cambridge, MA.
The site, scheduled for completion in 2026, will be in close proximity to several major academic, pharma and biotech institutions, inspiring greater collaboration and innovation potential, and providing access to future talent. The move reinforces AstraZeneca's commitment to the greater Boston area, with over 570,000 square feet of R&D and commercial space, and room for expansion for the future .
Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "Today's announcement is a milestone moment following the acquisition of Alexion in July 2021. Our combined company has already successfully leveraged internal scientific synergies, and this move will act as a catalyst for even more external collaboration and innovation.
"Kendall Square, Cambridge, is at the heart of the life sciences and innovation hub of the greater Boston area, and our new site will put us right at the centre of this space. The move will provide access to some of the most innovative partners in academia and biotech, offering opportunities to accelerate our growth and collaborate with like-minded organisations as we continue to push the boundaries of science to deliver advances for patients. "
AstraZeneca's supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab), in combination with standard-of-care chemotherapy, has been accepted and granted Priority Review in the US for patients with locally advanced or metastatic biliary tract cancer (BTC).
The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is during the third quarter of 2022.
BTC is a group of rare and aggressive cancers that occur in the bile ducts and gallbladder. 2,3 Approximately 23,000 people in the US are diagnosed with BTC each year.2 These patients have a poor prognosis, with approximately 5% to 15% of patients with BTC surviving five years.4
Enhertu reduced the risk of disease progression or death by 50% vs. chemotherapy in patients with HER2-low metastatic breast cancer with HR-positive and HR-negative disease.
Detailed positive results from the pivotal DESTINY-Breast04 Phase III trial showed that Enhertu (trastuzumab deruxtecan) demonstrated superior and clinically meaningful progression-free survival (PFS) and overall survival (OS) in previously treated patients with HER2-low (immunohistochemistry (IHC) 1+ or IHC 2+/in-situ hybridisation (ISH)-negative) unresectable and/or metastatic breast cancer with hormone receptor (HR) positive or HR-negative disease versus standard of care physician's choice of chemotherapy. Results will be presented during the Plenary Session today at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, and have been simultaneously published in The New England Journal of Medicine .
Positive high-level results from a planned interim analysis of the AEGEAN Phase III trial showed treatment with AstraZeneca's Imfinzi (durvalumab) in combination with neoadjuvant chemotherapy before surgery demonstrated a statistically significant and meaningful improvement in pathologic complete response (pCR) compared to neoadjuvant chemotherapy alone for patients with resectable non-small cell lung cancer (NSCLC).
A statistically significant improvement in major pathologic response (MPR) was also observed. The trial will continue as planned to assess the additional primary endpoint of event-free survival (EFS) to which the Company, investigators and participants remain blinded.
The safety and tolerability of adding Imfinzi to neoadjuvant chemotherapy was consistent with the known profile for this combination and did not decrease the number of patients able to undergo successful surgery versus chemotherapy alone.
Up to 30% of all patients globally with NSCLC are diagnosed early enough to have surgery with curative intent.1-3 However, only around 56-65% of patients with Stage II disease will survive for five-years. This decreases to 24-41% for patients with Stage III disease.4
Susan Galbraith, Executive Vice President, Oncology R&D, said: ''Treating resectable lung cancer early provides the best chance for a cure, yet lung cancer will still recur within five years for the majority of patients despite chemotherapy and successful surgery. Engaging the immune response with Imfinzi both before and after surgery is an exciting new strategy, and we hope these early findings from AEGEAN will lead to improved survival for lung cancer patients in this potentially curative setting."
AstraZeneca today announced an agreement to acquire TeneoTwo, Inc. (TeneoTwo) i , including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486 , currently under evaluation in relapsed and refractory B-cell non-Hodgkin lymphoma1.
The acquisition of TNB-486 aims to accelerate the development of this potential new medicine for B-cell haematologic malignancies, including diffuse large B-cell lymphoma and follicular lymphoma. Building on the success of Calquence (acalabrutinib), TNB-486 further diversifies AstraZeneca's haematology pipeline that spans multiple therapeutic modalities and mechanisms to address a broad spectrum of blood cancers .
TNB-486 belongs to a class of therapeutic antibodies known as T-cell engagers, which are emerging as a promising therapeutic approach in haematologic malignancies and solid tumours. T-cell engagers are bispecific molecules that are engineered to redirect the immune system's T-cells to recognise and kill cancer cells. By binding to both CD19, an antigen expressed on B-cells, and to the CD3 receptor on T-cells, TNB-486 activates and recruits T-cells to CD19-expressing tumours where they can elicit an immune response.
AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.
AstraZeneca and Daiichi Sankyo have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu (trastuzumab deruxtecan) for the treatment of adult patients in the US with unresectable or metastatic HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridisation [ISH]-negative) breast cancer who have received a prior therapy in the metastatic setting. The application has been granted Priority Review.
Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
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