AstraZeneca Updates on AL Amyloidosis Drug Anselamimab

TL;DR

AZN provides an update on anselamimab for AL amyloidosis.

AI Summary

AstraZeneca PLC announced an update on its investigational drug anselamimab for AL amyloidosis on July 16, 2025. The company is providing this information as part of its ongoing reporting requirements.

Why It Matters

This update provides stakeholders with the latest information on the development of anselamimab, a potential new treatment for AL amyloidosis, a rare and serious disease.

Risk Assessment

Risk Level: low — This filing is a routine report of foreign issuer information and does not contain new material financial or strategic information.

Key Players & Entities

• AstraZeneca PLC (company) — Registrant
• anselamimab (drug) — Investigational drug for AL amyloidosis
• AL amyloidosis (disease) — Condition being treated
• July 2025 (date) — Reporting period
• 001-11960 (filing_id) — SEC File Number

FAQ

From the Filing

0001654954-25-008111.txt : 20250716 0001654954-25-008111.hdr.sgml : 20250716 20250716064930 ACCESSION NUMBER: 0001654954-25-008111 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20250716 FILED AS OF DATE: 20250716 DATE AS OF CHANGE: 20250716 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ASTRAZENECA PLC CENTRAL INDEX KEY: 0000901832 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences EIN: 000000000 STATE OF INCORPORATION: X0 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-11960 FILM NUMBER: 251126135 BUSINESS ADDRESS: STREET 1: 1 FRANCIS CRICK AVENUE STREET 2: CAMBRIDGE BIOMEDICAL CAMPUS CITY: CAMBRIDGE STATE: X0 ZIP: CB2 0AA BUSINESS PHONE: 011 44 20 7304 5000 MAIL ADDRESS: STREET 1: 1 FRANCIS CRICK AVENUE STREET 2: CAMBRIDGE BIOMEDICAL CAMPUS CITY: CAMBRIDGE STATE: X0 ZIP: CB2 0AA FORMER COMPANY: FORMER CONFORMED NAME: ZENECA GROUP PLC DATE OF NAME CHANGE: 19930422 6-K 1 a2015r.htm UPDATE ON ANSELAMIMAB IN AL AMYLOIDOSIS a2015r FORM 6-K   SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549     Report of Foreign Issuer   Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934   For the month of July 2025   Commission File Number: 001-11960   AstraZeneca PLC   1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2 0AA United Kingdom     Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.   Form 20-F X Form 40-F __   Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):   Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ______   Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.   Yes __ No X   If “Yes” is marked, indicate below the file number assigned to the Registrant in connection with Rule 12g3-2(b): 82-_____________       AstraZeneca PLC   INDEX TO EXHIBITS   1. Update on anselamimab in AL amyloidosis     16 July 2025   Update on CARES Phase III clinical programme of anselamimab in light chain amyloidosis    Results did not achieve statistical significance for the primary endpoint in overall patient population   Anselamimab showed   highly clinically meaningful improvement vs. placebo in survival and cardiovascular hospitalisation in prespecified patient subgroup   High-level results from the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase III clinical programme showed that anselamimab, a light chain depleter antibody, did not achieve statistical significance for the primary endpoint compared to placebo in patients with Mayo stages IIIa and IIIb light chain (AL) amyloidosis. The primary endpoint was defined as a hierarchical combination of time to all-cause mortality (ACM) and frequency of cardiovascular hospitalisations (CVH). All patients in the clinical programme received background standard of care for plasma cell dyscrasia.   Anselamimab showed highly clinically meaningful improvement in time to ACM and frequency of CVH in a prespecified subgroup of patients, compared to placebo.     AL amyloidosis is a rare, systemic and progressive disorder caused by defective plasma cells in the bone marrow. In AL amyloidosis, abnormal light chain proteins produced by these plasma cells misfold, aggregate and form amyloid fibrils that deposit in tissues and organs. Left untreated, the accumulation of these toxic amyloid deposits, particularly in the heart and kidneys, can caus