Astrazeneca Plc - AZN STOCK NEWS

Alexion, AstraZeneca Rare Disease has launched an interactive e-book titled 'Revealing the Secrets of aHUS' to help children understand atypical Haemolytic Uraemic Syndrome (aHUS), a rare kidney disease affecting 0.4-0.5 people per million. The storybook, developed in collaboration with Kidney Care UK and Newcastle National Renal Complement Therapeutics Centre, targets children aged 6-10.

The interactive book transforms complex medical information into an engaging adventure where readers become the 'Guardian of Healthoria.' Children can personalize their character and complete various challenges while learning about kidneys, the immune system, and aHUS management. The resource is available across multiple platforms, including laptops, tablets, mobile phones, and print.

The initiative addresses a significant need, as 3.5 million people in the UK live with rare diseases, with 75% of these conditions affecting children. The book focuses on four key areas: the patient journey, kidney function, emotional support, and the daily impact of aHUS.

AstraZeneca (AZN) reported strong financial results for FY 2024, with Total Revenue increasing 21% to $54,073m and Core EPS growing 19% to $8.21. The growth was driven by a 19% increase in Product Sales, along with significant growth in Alliance Revenue and Collaboration Revenue.

Revenue growth was robust across all segments: Oncology (24%), CVRM (20%), R&I (25%), V&I (8%), and Rare Disease (16%). The company declared a second interim dividend of $2.10 per share, bringing the total annual dividend for FY 2024 to $3.10, a 7% increase.

For FY 2025, AstraZeneca projects high single-digit percentage growth in Total Revenue and low double-digit percentage growth in Core EPS. The company achieved multiple regulatory approvals across major markets and reported positive clinical trial results, supporting their Ambition 2030 goal of reaching $80 billion Total Revenue by decade's end.

Datopotamab deruxtecan (Dato-DXd) has received a positive CHMP recommendation for EU approval in treating adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have previously received endocrine therapy and chemotherapy in advanced settings.

The recommendation is based on the TROPION-Breast01 phase 3 trial results, which showed that Dato-DXd reduced the risk of disease progression or death by 37% compared to standard chemotherapy. The median progression-free survival was 6.9 months for Dato-DXd versus 4.9 months for chemotherapy. The objective response rate was 36% for Dato-DXd compared to 23% for chemotherapy.

The drug demonstrated a favorable safety profile with 21% of patients experiencing Grade 3 or higher treatment-related adverse events compared to 45% in the chemotherapy arm. The drug is already approved in Japan and the U.S., with additional regulatory submissions under review in China and other regions.

AstraZeneca and Daiichi Sankyo have initiated the TROPION-Lung12 Phase 3 trial, dosing their first patient to evaluate DATROWAY® (datopotamab deruxtecan) plus rilvegostomig or rilvegostomig monotherapy versus standard of care. The trial targets patients with stage 1 adenocarcinoma non-small cell lung cancer (NSCLC) after complete surgical resection who are ctDNA-positive or have high-risk pathological features.

Currently, stage 1 NSCLC treatment involves tumor resection, but up to 40% of patients may experience disease recurrence. While observation typically follows resection, adjuvant chemotherapy and/or immunotherapy may be offered to high-risk stage 1b patients. The trial aims to explore DATROWAY's potential role in combination with immunotherapy as an adjuvant treatment to prevent disease recurrence.

ENHERTU has received FDA approval for treating adult patients with unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer that has progressed after endocrine therapies. The approval was based on the DESTINY-Breast06 Phase III trial, which demonstrated ENHERTU's superiority over chemotherapy with a median progression-free survival of 13.2 months versus 8.1 months.

The trial showed a 36% reduction in disease progression or death risk compared to chemotherapy, with a confirmed objective response rate of 62.6% for ENHERTU versus 34.4% for chemotherapy. The safety profile remained consistent with previous trials, with no new concerns identified. This approval expands ENHERTU's availability to an earlier HR-positive treatment setting and broadens the eligible patient population to include those with HER2-ultralow disease.

ENHERTU® has received FDA approval as the first HER2-directed therapy for patients with HER2 low or HER2 ultralow metastatic breast cancer who experienced disease progression after endocrine therapy. The approval is based on the DESTINY-Breast06 phase 3 trial, where ENHERTU showed:

- 36% reduction in disease progression or death risk vs chemotherapy
- Median progression-free survival of 13.2 months vs 8.1 months with chemotherapy
- 62.6% objective response rate vs 34.4% with chemotherapy
- 14.3 months median duration of response vs 8.6 months with chemotherapy

The drug, jointly developed by Daiichi Sankyo and AstraZeneca, received Priority Review and Breakthrough Therapy Designation. Following this approval, AstraZeneca will pay Daiichi Sankyo a $175 million milestone payment.

DATROWAY® (datopotamab deruxtecan-dlnk) has received FDA approval for treating adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have previously received endocrine-based therapy and chemotherapy. The approval is based on the TROPION-Breast01 phase 3 trial results, which demonstrated:

- 37% reduction in disease progression or death risk versus chemotherapy
- Median progression-free survival of 6.9 months vs 4.9 months with chemotherapy
- Objective response rate of 36% vs 23% with chemotherapy
- Median duration of response of 6.7 months vs 5.7 months with chemotherapy

DATROWAY, jointly developed by Daiichi Sankyo and AstraZeneca, is the second DXd antibody drug conjugate approved in the U.S. The drug will be available by prescription in approximately two weeks.

DATROWAY® (datopotamab deruxtecan-dlnk) has received FDA approval for treating adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy. The approval was based on the TROPION-Breast01 Phase III trial results, which showed a 37% reduction in the risk of disease progression or death compared to chemotherapy.

The trial demonstrated a median progression-free survival of 6.9 months for DATROWAY versus 4.9 months with chemotherapy. The safety profile was consistent with known data, with an interstitial lung disease rate of 4.2%, mostly low grade. This marks AstraZeneca's eighth new medicine of their targeted 20 medicines by 2030.

AstraZeneca's CALQUENCE (acalabrutinib) in combination with bendamustine and rituximab has received FDA approval for treating previously untreated mantle cell lymphoma (MCL) in adult patients ineligible for autologous stem cell transplantation. The approval was based on the ECHO Phase III trial results, which demonstrated a 27% reduction in disease progression or death risk compared to standard chemoimmunotherapy.

The trial showed median progression-free survival of 66.4 months for the CALQUENCE combination versus 49.6 months with chemoimmunotherapy alone. After censoring COVID-19 deaths, the risk reduction improved to 36%. This makes CALQUENCE the first and only BTK inhibitor approved for first-line MCL treatment in the US.

MCL is a rare and aggressive form of non-Hodgkin lymphoma, with over 21,000 patients diagnosed across major markets. The safety profile was consistent with known data, and no new safety signals were identified.