Astrazeneca Plc Stock Price, News & Analysis

Fusion Pharmaceuticals (FUSN) announced the FDA clearance of IND applications for FPI-2068 and imaging analogue FPI-2107. FPI-2068 is a bispecific targeted alpha therapy (TAT) aimed at delivering actinium-225 to tumors expressing EGFR and cMET, validated targets in cancer treatment. This IND filing marks a critical milestone in the development collaboration with AstraZeneca (AZN), indicating plans for a Phase 1 clinical study. The therapy is intended to enhance tumor specificity and patient screening using corresponding imaging isotopes, potentially increasing therapeutic response rates. The development will be shared equally between Fusion and AstraZeneca through clinical phases, with Fusion managing the initial trial.

AstraZeneca showcased five real-world evidence (RWE) studies from its Cardiovascular, Renal, and Metabolism (CVRM) portfolio at the National Kidney Foundation Spring Clinical Meeting held from April 11-15, 2023. The presented REVOLUTIONIZE I study highlighted the recurrence of hyperkalemia (HK) in chronic kidney disease (CKD) patients following dietary counseling, with rates rising from 37.4% at one month to 56% at six months. Notably, patients with prior HK recurrences experienced shorter intervals between episodes. The study indicates a need for effective treatments like LOKELMA to manage HK in this patient population. AstraZeneca's commitment to developing therapies addressing CKD and HK underscores its strategy to advance patient care.

AstraZeneca announced positive outcomes from the NEURO-TTRansform Phase III trial for eplontersen, targeting hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). Results at 66 weeks indicated that eplontersen met its co-primary endpoints, showing significant improvement in neuropathic disease progression and quality of life measures compared to a placebo. The third endpoint demonstrated significant TTR concentration reduction. Eplontersen, now seeking regulatory approval in the US and Europe, was also accepted for New Drug Application by the FDA, highlighting its potential as a best-in-class treatment amidst urgent medical needs in the field.

AstraZeneca announced positive results from the ADAURA Phase III trial, showing that TAGRISSO (osimertinib) significantly improves overall survival in patients with early-stage EGFR-mutated non-small cell lung cancer (NSCLC) after complete tumor resection. This trial enrolled 682 patients and demonstrated a clinically meaningful survival benefit, reinforcing TAGRISSO's role as a standard treatment in this setting. The safety profile remained consistent with previous studies, with no new major safety concerns raised. AstraZeneca is expanding research on TAGRISSO, including ongoing trials in earlier stages of lung cancer.

AstraZeneca announced positive interim results from the AEGEAN Phase III trial, demonstrating that IMFINZI (durvalumab) combined with neoadjuvant chemotherapy significantly improves event-free survival (EFS) for patients with early-stage non-small cell lung cancer (NSCLC). In the study, IMFINZI was given before and after surgery, showing a clinically meaningful benefit over chemotherapy alone. The results align with previous findings regarding pathologic response rates. The trial continues to evaluate key secondary endpoints such as disease-free survival and overall survival. IMFINZI was well tolerated, and no new safety concerns were reported.

Personalis, Inc. (Nasdaq: PSNL) announced an ongoing collaboration with AstraZeneca (LSE/STO/Nasdaq: AZN) to explore ultra-sensitive molecular residual disease (MRD) measurement using Personalis' NeXT Personal® assay. This partnership aims to enhance the detection of circulating tumor DNA (ctDNA) and clinically relevant mutations to guide cancer therapy. The CALLA trial will focus on locally advanced cervical cancer, assessing the roles of ctDNA and HPV detection in plasma. Personalis emphasizes the assay's high sensitivity and specificity, crucial for early and personalized patient interventions.

Genomic Vision has launched FiberSmart®, an AI-based technology that enhances the analysis of fluorescent signals in DNA. This platform offers up to three times more precision and ten times faster analysis compared to previous software solutions. Successfully tested by AstraZeneca and the Fritz Lipmann Institute, FiberSmart® is compatible with Genomic Vision’s scanners and aims to improve genomic analysis in cell and gene therapy. However, the company has initiated convertible note financing, which could cause dilution and downward pressure on share value, risking shareholder capital.

AstraZeneca and Daiichi Sankyo reported promising results from the DESTINY-PanTumor02 Phase II trial of ENHERTU (fam-trastuzumab deruxtecan-nxki). The therapy met the prespecified criteria for objective response rate (ORR) and showed durable response in patients with HER2-expressing advanced tumors not eligible for curative treatment. The trial focuses on various cancers including biliary tract and pancreatic cancers. Safety data confirmed no new safety signals. The findings will be shared at an upcoming medical meeting and with regulatory authorities, highlighting ENHERTU's expanding role in addressing significant unmet medical needs.

Alexion, a part of AstraZeneca Rare Disease, will present vital findings at the American Academy of Neurology Annual Meeting from April 22-27, 2023. The company will showcase 19 abstracts focused on C5 inhibition therapies for rare neurological diseases, including generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Key data will highlight the efficacy and safety of ULTOMIRIS® and SOLIRIS®. Notably, new Phase I data for gefurulimab, an investigational C5 inhibitor, reinforces its future Phase III trials in gMG. CEO Marc Dunoyer emphasized the company’s commitment to innovative treatments for rare disease communities.