AstraZeneca PLC - AZN STOCK NEWS

AstraZeneca announces a $3.5 billion capital investment in the United States to expand its research and manufacturing footprint by 2026. The investment includes $2 billion of new funding that will create over 1,000 high-skilled jobs. The expansion encompasses a new R&D centre in Cambridge, Massachusetts, biologics manufacturing in Maryland, cell therapy facilities on both coasts, and specialty manufacturing in Texas. This investment is part of AstraZeneca's strategy to achieve $80 billion in Total Revenue by 2030. The US currently represents 44% of AstraZeneca's Total Revenue, making it the company's largest market with 17,800 employees across 17 sites in 12 states.

AstraZeneca reported strong financial results for 9M 2024, with Total Revenue up 19% to $39,182m and Core EPS increasing 11% to $6.12. Product Sales grew 19%, with significant growth across all therapeutic areas: Oncology (22%), CVRM (21%), R&I (24%), and Rare Disease (14%). The company maintained a Core Product Sales Gross Margin of 82% and Core Operating Margin of 32%. Based on strong performance and increased confidence in achieving sales milestones, AstraZeneca upgraded its FY 2024 guidance, now expecting high teens percentage growth for both Total Revenue and Core EPS.

Daiichi Sankyo and AstraZeneca have submitted a new Biologics License Application (BLA) for accelerated approval of datopotamab deruxtecan to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior therapies. The application is based on the TROPION-Lung05 phase 2 trial, supported by additional trial data. The companies have withdrawn their previous BLA for nonsquamous NSCLC following FDA feedback. New results from a pooled analysis of patients with previously treated EGFR-mutated NSCLC will be presented at ESMO Asia 2024. The companies are conducting additional phase 3 trials evaluating the treatment alone and in combination with osimertinib.

ENHERTU, a HER2-directed antibody drug conjugate (ADC) jointly developed by Daiichi Sankyo and AstraZeneca, has received the prestigious 2024 Prix Galien USA Award for Best Biotechnology Product. The award, considered the industry's Nobel Prize equivalent, recognizes ENHERTU's contribution to redefining metastatic breast cancer treatment and its breakthrough as the first tumor-agnostic approval for HER2 positive solid tumors in the U.S. The Prix Galien USA Award winners are selected by a committee of renowned scientists and clinicians, acknowledging the most impactful FDA-approved treatments within the past five years.

AstraZeneca and Amgen's TEZSPIRE demonstrated positive results in the Phase III WAYPOINT trial for chronic rhinosinusitis with nasal polyps (CRSwNP). The trial showed statistically significant and clinically meaningful reduction in nasal polyp size and nasal congestion compared to placebo. The study evaluated TEZSPIRE's efficacy and safety when administered subcutaneously to adults with severe CRSwNP who remained symptomatic despite standard treatment. The safety profile was consistent with previous findings. TEZSPIRE is currently approved for severe asthma treatment in the US, EU, Japan, and nearly 60 countries globally.

AstraZeneca will present new data across its hematology portfolio at the 66th American Society of Hematology Annual Meeting in December 2024. The company will showcase 57 abstracts featuring 13 approved and potential new medicines. Key highlights include:

- First results from AMPLIFY Phase III trial for CALQUENCE in frontline chronic lymphocytic leukemia
- New data for AZD0486 showing high response rates in lymphoma patients
- Long-term data for VOYDEYA as add-on therapy showing low breakthrough hemolysis rates
- Early results for AZD0120, a novel CAR T cell therapy for multiple myeloma

Daiichi Sankyo and AstraZeneca have initiated three global Phase 3 trials evaluating datopotamab deruxtecan (Dato-DXd) combinations in advanced nonsquamous non-small cell lung cancer (NSCLC). The trials include: TROPION-Lung10 testing Dato-DXd plus rilvegostomig in high PD-L1 expression patients; TROPION-Lung14 evaluating Dato-DXd plus osimertinib in EGFR mutated NSCLC; and TROPION-Lung15 studying Dato-DXd with/without osimertinib in EGFR mutated NSCLC that progressed on osimertinib. These trials are part of the expanding TROPION program, which now includes seven Phase 3 trials.

AstraZeneca's AIRSUPRA® (albuterol/budesonide) demonstrated statistically significant and clinically meaningful reduction in the risk of severe exacerbations in patients with intermittent or mild persistent asthma in the BATURA Phase III trial. The trial was stopped early due to overwhelming efficacy at a pre-planned analysis.

Key points:

• AIRSUPRA met the primary endpoint when used as an as-needed rescue medication compared to as-needed albuterol
• The trial included patients on short-acting beta2-agonist (SABA) alone, low-dose inhaled corticosteroid (ICS) maintenance therapy, or leukotriene receptor antagonist (LTRA) maintenance therapy
• Asthma affects 262 million people worldwide, including over 25 million in the US
• AIRSUPRA is the first anti-inflammatory rescue medication approved in the US for as-needed treatment of asthma in adults 18 years and older
• Safety and tolerability were consistent with AIRSUPRA's established profile

AstraZeneca's supplemental New Drug Application (sNDA) for CALQUENCE® (acalabrutinib) has been granted Priority Review by the FDA for treating previously untreated mantle cell lymphoma (MCL) in adults. This is based on the ECHO Phase III trial, which showed CALQUENCE combination reduced the risk of disease progression or death by 27% compared to standard chemoimmunotherapy.

Key points:

• FDA decision expected in Q1 2025
• MCL is a rare, aggressive form of non-Hodgkin lymphoma
• CALQUENCE plus bendamustine and rituximab provided almost 1.5 years additional median progression-free survival
• Safety profile consistent with known data
• Application being reviewed under Project Orbis for potential international approval