AstraZeneca PLC (AZN)

[idpickering]

AstraZeneca completes Cellectis equity investment

AstraZeneca today announced the successful completion of an equity investment with Cellectis, a clinical-stage biotechnology company.

https://www.investegate.co.uk/announcem ... nt/8177375

Ian.

[idpickering]

SUPERNOVA Phase III trial of sipavibart long-acting antibody met primary endpoints in preventing COVID-19 in immunocompromised patient population

Positive high-level results from the SUPERNOVA Phase III COVID-19 pre-exposure prophylaxis (prevention) trial showed AstraZeneca's sipavibart (formerly AZD3152), an investigational long-acting antibody (LAAB), demonstrated a statistically significant reduction in the incidence of symptomatic COVID‑19 compared to control (tixagevimab/cilgavimab or placebo) in an immunocompromised patient population.

https://www.investegate.co.uk/announcem ... nt/8200091

Ian.

[idpickering]

AstraZeneca to manufacture ADCs in Singapore

AstraZeneca plans $1.5 billion manufacturing facility for antibody drug conjugates (ADCs) in Singapore

Operationally ready by 2029, it will be the Company's first-ever facility to cover the full manufacturing process for ADCs

AstraZeneca intends to build a $1.5 billion manufacturing facility in Singapore for antibody drug conjugates (ADCs), enhancing global supply of its ADC portfolio. ADCs are next-generation treatments that deliver highly potent cancer-killing agents directly to cancer cells through a targeted antibody.

The planned greenfield facility, supported by the Singapore Economic Development Board (EDB), will be AstraZeneca's first end-to-end ADC production site, fully incorporating all steps of the manufacturing process at a commercial scale. Manufacturing of ADCs is a multi-step process that comprises antibody production, synthesis of chemotherapy drug and linker, conjugation of drug-linker to the antibody, and filling of the completed ADC substance.

Png Cheong Boon, Chairman, EDB said: "We welcome AstraZeneca's decision to establish a manufacturing presence in Singapore for the first time. It will also be a first for AstraZeneca - an end-to-end manufacturing facility for novel antibody drug conjugates that enables precision therapy for cancer. This greenfield investment is a strong show of confidence in Singapore's biopharmaceutical manufacturing capabilities and talent, strengthens our ecosystem in supporting the development and manufacturing of precision medicines, and creates meaningful jobs and economic opportunities for Singapore. We look forward to a successful partnership with AstraZeneca."

Pascal Soriot, Chief Executive Officer, AstraZeneca, said: "AstraZeneca has built an industry-leading portfolio of cancer medicines including antibody drug conjugates which have shown enormous potential to replace traditional chemotherapy for patients across many settings. Singapore is one of the world's most attractive countries for investment given its reputation for excellence in complex manufacturing, and I am excited for AstraZeneca to locate our $1.5 billion ADC manufacturing facility in the country."

AstraZeneca has a broad portfolio of in-house ADCs including six wholly owned ADCs in the clinic and many more in preclinical development.

https://www.investegate.co.uk/announcem ... re/8206937

Ian (I hold).

[idpickering]

Heads up! The AZN CFO is being interviewed on Bloomberg TV at 0815hrs (UK) today.

Ian.

[idpickering]

AstraZeneca sets ambition to deliver $80 billion Total Revenue by 2030 and sustained growth post 2030

Today AstraZeneca revealed its bold ambition to deliver $80 billion in Total Revenue by 2030, up from $45.8 billion in 2023. This will be achieved through significant growth in its existing oncology, biopharmaceuticals and rare disease portfolio, and by launching an expected 20 new medicines before the end of the decade. To drive sustained growth beyond 2030, the Company will continue investing in transformative new technologies and platforms that will shape the future of medicine.

AstraZeneca will maintain its strategic commitment to R&D while focusing on productivity throughout the Company, driving operating leverage and enabling the delivery of its ambition for a mid-30s percentage Core operating margin by 2026. Beyond 2026, Core operating margin will be influenced by portfolio evolution and the company will target at least the mid-30s percentage range.

Pascal Soriot, Chief Executive Officer, AstraZeneca said: "Today AstraZeneca announces a new era of growth. In 2023 we delivered the ambitious $45 billion revenue goal set a decade ago. With the exciting growth of our innovative pipeline, which has the potential to transform millions of lives, we are now aiming for $80 billion by 2030.

We are planning to launch 20 new medicines by 2030, many with the potential to generate more than $5 billion in peak year revenues. The breadth of our portfolio together with continued investment in innovation supports sustained growth well past the end of the decade."

https://www.investegate.co.uk/announcem ... 0-/8209889

Ian.

[idpickering]

Dato-DXd improved OS in nonsquamous lung cancer

High-level overall survival (OS) results from the TROPION-Lung01 Phase III trial, which previously met the dual primary endpoint of progression-free survival (PFS), numerically favoured datopotamab deruxtecan (Dato-DXd) compared to docetaxel in the overall trial population of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior line of therapy. Survival results did not reach statistical significance in the overall trial population. In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard-of-care chemotherapy.

https://www.investegate.co.uk/announcem ... er/8224095

Ian.

[idpickering]

Tagrisso plus chemo recommended for approval in EU

AstraZeneca's Tagrisso (osimertinib) with the addition of pemetrexed and platinum-based chemotherapy has been recommended for approval in the European Union (EU) for 1st-line treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.

https://www.investegate.co.uk/announcem ... eu/8237078

Ian (I hold).

[idpickering]

Acquisition of Fusion completed

AstraZeneca today announced the successful completion of the acquisition of Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates (RCs). The acquisition marks a major step forward in AstraZeneca delivering on its ambition to transform cancer treatment and outcomes for patients by replacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments.

This acquisition complements AstraZeneca's leading oncology portfolio with the addition of the Fusion pipeline of RCs, including their most advanced programme, FPI-2265, a potential new treatment for patients with metastatic castration-resistant prostate cancer (mCRPC), and brings new expertise and pioneering R&D, manufacturing and supply chain capabilities in actinium-based RCs to AstraZeneca. It also strengthens AstraZeneca's presence in and commitment to Canada.

As a result of the acquisition, Fusion has become a wholly owned subsidiary of AstraZeneca, with operations in Canada and the US.

https://www.investegate.co.uk/announcem ... d-/8242554

Ian.

[idpickering]

Imfinzi approved in the US for endometrial cancer

AstraZeneca's Imfinzi (durvalumab) in combination with carboplatin and paclitaxel followed by Imfinzi monotherapy has been approved in the US as treatment for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).1

https://www.investegate.co.uk/announcem ... er/8261745

Ian.

[idpickering]

Update on CAPItello-290 Phase III trial

The CAPItello-290 Phase III trial for Truqap (capivasertib) in combination with paclitaxel in patients with locally advanced (inoperable) or metastatic triple-negative breast cancer (TNBC) did not meet the dual primary endpoints of improvement in overall survival (OS) versus paclitaxel in combination with placebo in either the overall trial population or in a subgroup of patients with tumours harbouring specific biomarker alterations (PIK3CA, AKT1 or PTEN).

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 While some breast cancers may test positive for estrogen receptors, progesterone receptors or overexpression of human epidermal growth factor receptor 2 (HER2), TNBC is defined as negative for all three.2 In the 1st-line setting, approximately 59,000 patients with TNBC are treated with a medicine.3 Collectively, mutations in PIK3CA, AKT1 and alterations in PTEN affect approximately 35% of patients with TNBC.4

https://www.investegate.co.uk/announcem ... al/8264159

Ian.

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Imfinzi demonstrated statistically significant and clinically meaningful improvement in event-free survival and overall survival for muscle-invasive bladder cancer in NIAGARA Phase III trial.

Positive high-level results from the NIAGARA Phase III trial showed AstraZeneca's Imfinzi (durvalumab) in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint of overall survival (OS) versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer (MIBC). Patients were treated with Imfinzi in combination with neoadjuvant chemotherapy before cystectomy (surgery to remove the bladder) followed by Imfinzi as adjuvant monotherapy.

Approximately one in four patients with bladder cancer has evidence of the tumour invading the muscle wall of the bladder (without distant metastases), known as MIBC.1,2 In the MIBC setting, approximately 117,000 patients are treated with current standard of care.3 Standard treatment includes neoadjuvant chemotherapy and radical cystectomy.4 However, even after cystectomy, patients experience high rates of recurrence and a poor prognosis.4

https://www.investegate.co.uk/announcem ... er/8275765

Ian.

[idpickering]

Update on ADJUVANT BR.31 Phase III trial of Imfinzi in non-small cell lung cancer.

High-level results from the ADJUVANT BR.31 Phase III trial, sponsored by the Canadian Cancer Trials Group (CCTG), showed Imfinzi (durvalumab) did not achieve statistical significance for the primary endpoint of disease-free survival (DFS) versus placebo in early-stage (IB-IIIA) non-small cell lung cancer (NSCLC) after complete tumour resection in patients whose tumours express PD-L1 on 25% or more tumour cells.

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "We are disappointed in the ADJUVANT BR.31 results. Imfinzi has helped change the treatment landscape and achieved multiple positive Phase III trials for patients with earlier stages of lung cancer. We are committed to addressing the remaining unmet need in lung cancer through our broad development programme."

https://www.investegate.co.uk/announcem ... al/8275984

Ian.

[idpickering]

Lynparza & Imfinzi positive CHMP in endometrial.

AstraZeneca's Imfinzi (durvalumab) and Lynparza (olaparib) have been recommended for approval in the European Union (EU) as treatment for certain patients with primary advanced or recurrent endometrial cancer. Imfinzi plus chemotherapy as 1st-line treatment followed by Lynparza and Imfinzi has been recommended for patients with mismatch repair proficient (pMMR) disease. Imfinzi plus chemotherapy followed by Imfinzi alone has been recommended for patients with mismatch repair deficient (dMMR) disease.

https://www.investegate.co.uk/announcem ... al/8286027

Ian (I hold).