AstraZeneca PLC - AZN STOCK NEWS

AstraZeneca has commenced the IRIS Phase III clinical trial for anifrolumab, targeting lupus nephritis (LN), a severe kidney complication affecting up to 60% of lupus patients. Anifrolumab, a type I interferon receptor antibody, aims to provide new treatment options for LN, which often leads to dialysis and early mortality. The trial will enroll 360 patients and evaluate anifrolumab's effectiveness against a placebo when combined with standard therapies. Despite Phase II results not meeting primary endpoints, secondary outcomes showed promise, paving the way for further development.

AstraZeneca announced groundbreaking data for ENHERTU® at the ASCO Annual Meeting, showing potential to improve survival rates in patients with HER2-low metastatic breast cancer. Results from the DESTINY-Breast04 Phase III trial indicate statistically significant benefits in overall survival and progression-free survival. The portfolio includes 18 medicines featured across 100 abstracts, highlighting the company's commitment to innovation in oncology. The firm aims to redefine cancer care while presenting favorable data for other therapeutics such as CALQUENCE, IMFINZI, and LYNPARZA.

AstraZeneca (AZN) has expanded its collaboration with Proteros biostructures GmbH, focusing on the discovery and development of novel epigenetic drugs. The multi-year agreement builds upon a prior collaboration from June 2021 and includes research funding along with potential milestone payments up to USD 75 million plus tiered royalties on net sales. Proteros will leverage its expertise in drug-target interactions using advanced technologies like X-ray crystallography and cryo-Electron Microscopy to enhance drug discovery efficiency.

The MANDALA Phase III trial has unveiled that PT027, a fixed-dose combination of albuterol and budesonide, reduces severe asthma exacerbations by 27% compared to albuterol alone. This first-of-its-kind inhaler also achieved a 33% reduction in systemic corticosteroid exposure and demonstrated enhanced symptom control and quality of life after 24 weeks. The trial included over 3,000 participants with moderate to severe asthma. AstraZeneca anticipates PT027 could transform asthma rescue treatments, aligning with its strategy to innovate in respiratory care.

Baili-Biopharmaceutical and SystImmune announced a collaboration with AstraZeneca to conduct a Phase 2a clinical trial assessing the efficacy of SI-B001, a bispecific antibody targeting EGFR and HER3, alongside AstraZeneca's TAGRISSO® (osimertinib) for treating non-small cell lung cancer (NSCLC). Initial Phase 1 results of SI-B001 indicated good tolerability and early efficacy signs. The financial details of the agreement remain undisclosed. This partnership aims to enhance treatment options for patients with NSCLC, a prevalent cancer type worldwide.

AstraZeneca announced significant results from the DELIVER Phase III trial, demonstrating that FARXIGA (dapagliflozin) effectively reduces cardiovascular death and worsening heart failure in patients with mildly reduced or preserved ejection fraction (LVEF > 40%). With heart failure affecting nearly 64 million people globally, these results extend treatment options for patients with limited therapies. The trial involved 6,263 patients, affirming FARXIGA's positive safety profile.

The full results will be presented at an upcoming medical meeting.

ULTOMIRIS (ravulizumab-cwvz) has demonstrated zero adjudicated relapses over a median treatment duration of 73 weeks in the Phase III CHAMPION-NMOSD trial for adults with anti-AQP4 antibody-positive NMOSD. The trial revealed a statistically significant reduction in relapse risk, achieving its primary endpoint concerning time to first relapse. The safety profile was consistent with previous studies, with ongoing long-term treatment for 56 patients. Data will be submitted to health authorities to expedite ULTOMIRIS availability for the NMOSD community.

AstraZeneca and Daiichi Sankyo's ENHERTU has received FDA approval for earlier use in treating unresectable or metastatic HER2-positive breast cancer. This decision is based on the DESTINY-Breast03 Phase III trial results, which showed a 72% reduction in disease progression or death compared to trastuzumab emtansine. The approval broadens ENHERTU's indication to patients who recur within six months of prior anti-HER2 therapies. The approval initiates a $100 million milestone payment from AstraZeneca to Daiichi Sankyo.

Daiichi Sankyo and AstraZeneca’s ENHERTU has received FDA approval for earlier use in treating HER2 positive metastatic breast cancer. The approval follows the DESTINY-Breast03 trial, proving ENHERTU reduces disease progression or death risk by 72% compared to T-DM1. With a median progression-free survival not reached for ENHERTU versus 6.8 months for T-DM1, this milestone expands treatment options for patients. Additionally, a milestone payment of $100 million is due from AstraZeneca to Daiichi Sankyo following this approval.