AMGN

AMGEN PRESENTS NEW LUMAKRAS® (SOTORASIB) PLUS CHEMOTHERAPY DATA IN FIRST-LINE KRAS G12C NSCLC AT WCLC

Retrieved on: 
Sunday, September 10, 2023

THOUSAND OAKS, Calif., Sept. 10, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced exciting data from a study arm of the CodeBreaK 101 clinical trial, a Phase 1b study evaluating LUMAKRAS® (sotorasib) with carboplatin and pemetrexed in adult patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). These results were featured in an oral presentation at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC) in Singapore on Sunday, September 10.

Key Points: 
  • In assessable patients in the second-line setting (n=13), the ORR was 54%, with a DCR of 85% (95% CI: 54.6, 98.1).
  • "Notably, these results follow and further expand upon the Phase 2 investigator-led data demonstrating favorable efficacy and safety of LUMAKRAS plus carboplatin and pemetrexed in the first-line treatment of patients with KRAS G12C-mutated NSCLC."
  • The LUMAKRAS plus chemotherapy combination reported treatment-related adverse events (TRAEs) consistent with LUMAKRAS and other platinum doublet-based approaches.
  • "The CodeBreaK 101 results show exciting efficacy with sotorasib plus chemotherapy and, importantly for a combination treatment, a safety profile consistent with the individual therapies.

AMGEN TO PRESENT AT THE MORGAN STANLEY GLOBAL HEALTHCARE CONFERENCE

Retrieved on: 
Thursday, September 7, 2023

THOUSAND OAKS, Calif., Sept. 7, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Morgan Stanley Global Healthcare Conference at 8:50 a.m.

Key Points: 
  • THOUSAND OAKS, Calif., Sept. 7, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the Morgan Stanley Global Healthcare Conference at 8:50 a.m.
  • Robert A. Bradway, chairman and chief executive officer at Amgen will present at the conference.
  • Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar.
  • The webcast will be archived and available for replay for at least 90 days after the event.

Amgen and Horizon Therapeutics plc Resolve FTC Lawsuit, Clearing Path to Close Acquisition

Retrieved on: 
Friday, September 1, 2023

Amgen (NASDAQ:AMGN) and Horizon Therapeutics plc (NASDAQ:HZNP) today announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit.

Key Points: 
  • Amgen (NASDAQ:AMGN) and Horizon Therapeutics plc (NASDAQ:HZNP) today announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit.
  • This clears the path to take the final steps to close Amgen’s acquisition of Horizon.
  • This narrow assurance, formalized in the consent order with the FTC, will have no impact on Amgen’s business.
  • The companies anticipate being able to close the acquisition in early fourth-quarter 2023 and look forward to the opportunity to serve patients around the world suffering from rare diseases.

AMGEN AND HORIZON THERAPEUTICS PLC RESOLVE FTC LAWSUIT, CLEARING PATH TO CLOSE ACQUISITION

Retrieved on: 
Friday, September 1, 2023

THOUSAND OAKS, Calif. and DUBLIN, Sept. 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Horizon Therapeutics plc (NASDAQ:HZNP) today announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit.

Key Points: 
  • THOUSAND OAKS, Calif. and DUBLIN, Sept. 1, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Horizon Therapeutics plc (NASDAQ:HZNP) today announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit.
  • This clears the path to take the final steps to close Amgen's acquisition of Horizon.
  • This narrow assurance, formalized in the consent order with the FTC, will have no impact on Amgen's business.
  • The companies anticipate being able to close the acquisition in early fourth-quarter 2023 and look forward to the opportunity to serve patients around the world suffering from rare diseases.

AMGEN TO PRESENT AT THE 2023 WELLS FARGO HEALTHCARE CONFERENCE AND THE CITI GLOBAL HEALTHCARE CONFERENCE

Retrieved on: 
Friday, September 1, 2023

THOUSAND OAKS, Calif., Aug. 31, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 2023 Wells Fargo Healthcare Conference at 9:30 a.m.

Key Points: 
  • THOUSAND OAKS, Calif., Aug. 31, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) will present at the 2023 Wells Fargo Healthcare Conference at 9:30 a.m.
  • ET on Wednesday, Sept. 6, 2023.
  • Amgen will also present at the Citi Global Healthcare Conference at 1:00 p.m.
  • Peter H. Griffith, executive vice president and chief financial officer at Amgen, and Murdo Gordon, executive vice president of global commercial operations at Amgen will present at both conferences.

AMGEN TO DISCUSS APPLICATION FOR LUMAKRAS® (SOTORASIB) FOR THE TREATMENT OF KRAS G12C-POSITIVE NSCLC AT FDA ADVISORY COMMITTEE MEETING

Retrieved on: 
Monday, August 21, 2023

LUMAKRAS/LUMYKRAS is approved in several markets outside the United States including Europe, South America, Asia and the European Union.

Key Points: 
  • LUMAKRAS/LUMYKRAS is approved in several markets outside the United States including Europe, South America, Asia and the European Union.
  • To date, over 6,500 patients around the world have received LUMAKRAS/LUMYKRAS through the clinical development program and commercial use.
  • Lumakras has demonstrated a favorable benefit/risk profile in multiple studies in non-small lung cancer and other tumor types such as colo-rectal cancer.
  • Amgen is progressing the largest and broadest global KRASG12C inhibitor development program exploring multiple combination regimens, with clinical trial sites spanning five continents.

INVESTIGATION ALERT: Scott+Scott Attorneys at Law LLP Investigates Amgen Inc’s Directors and Officers for Breach of Fiduciary Duties – AMGN

Retrieved on: 
Friday, August 11, 2023

NEW YORK, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Scott+Scott Attorneys at Law LLP (“Scott+Scott”), an international securities and consumer rights litigation firm, is investigating whether certain directors and officers of Amgen Inc. (“Amgen”) (NASDAQ: AMGN) breached their fiduciary duties to Amgen and its shareholders.

Key Points: 
  • NEW YORK, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Scott+Scott Attorneys at Law LLP (“Scott+Scott”), an international securities and consumer rights litigation firm, is investigating whether certain directors and officers of Amgen Inc. (“Amgen”) (NASDAQ: AMGN) breached their fiduciary duties to Amgen and its shareholders.
  • If you are an Amgen shareholder, you may contact attorney Joe Pettigrew for additional information toll-free at 844-818-6982, or [email protected] .
  • Scott+Scott is investigating whether members of Amgen’s board of directors or senior management failed to manage Amgen in an acceptable manner, in breach of their fiduciary duties to Amgen, and whether Amgen and its shareholders have suffered damages as a result.
  • If you are an Amgen shareholder, you may have legal claims against Amgen’s directors and officers.

AMGEN ANNOUNCES WEBCAST OF 2023 SECOND QUARTER FINANCIAL RESULTS

Retrieved on: 
Monday, July 31, 2023

THOUSAND OAKS, Calif., July 31, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it will report its second quarter financial results on Thursday, August 3, 2023, after the close of the U.S. financial markets.

Key Points: 
  • THOUSAND OAKS, Calif., July 31, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that it will report its second quarter financial results on Thursday, August 3, 2023, after the close of the U.S. financial markets.
  • Participating in the call from Amgen will be Robert A. Bradway, chairman and chief executive officer, and other members of Amgen's senior management team.
  • Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar.
  • The webcast will be archived and available for replay for at least 90 days after the event.

INVESTIGATION ALERT: Scott+Scott Attorneys at Law LLP Investigates Amgen Inc’s Directors and Officers for Breach of Fiduciary Duties – AMGN

Retrieved on: 
Thursday, July 27, 2023

Scott+Scott Attorneys at Law LLP (“Scott+Scott”), an international securities and consumer rights litigation firm, is investigating whether certain directors and officers of Amgen Inc. (“Amgen”) (NASDAQ: AMGN) breached their fiduciary duties to Amgen and its shareholders.

Key Points: 
  • Scott+Scott Attorneys at Law LLP (“Scott+Scott”), an international securities and consumer rights litigation firm, is investigating whether certain directors and officers of Amgen Inc. (“Amgen”) (NASDAQ: AMGN) breached their fiduciary duties to Amgen and its shareholders.
  • If you are an Amgen shareholder, you may contact attorney Joe Pettigrew for additional information toll-free at 844-818-6982, or [email protected] .
  • Scott+Scott is investigating whether members of Amgen’s board of directors or senior management failed to manage Amgen in an acceptable manner, in breach of their fiduciary duties to Amgen, and whether Amgen and its shareholders have suffered damages as a result.
  • If you are an Amgen shareholder, you may have legal claims against Amgen’s directors and officers.

FDA GRANTS FULL APPROVAL FOR BLINCYTO® (BLINATUMOMAB) TO TREAT MINIMAL RESIDUAL DISEASE-POSITIVE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKEMIA

Retrieved on: 
Wednesday, June 21, 2023

THOUSAND OAKS, Calif., June 21, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for BLINCYTO® (blinatumomab) for the treatment of adults and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%, based on additional data from two Phase 3 studies that were submitted. The approval converts BLINCYTO's accelerated approval to a full approval. 

Key Points: 
  • The approval converts BLINCYTO's accelerated approval to a full approval.
  • "We are pleased the FDA has granted full approval for BLINCYTO, the first FDA-approved CD19-directed CD3 T-cell engager BiTE® immunotherapy and the first to be FDA-approved for MRD in 2018," said David M. Reese, M.D., executive vice president of Research and Development at Amgen.
  • "Today's full approval underscores the clinical benefit of BLINCYTO for people living with B-ALL, and we look forward to exploring how we can continue to make a significant impact for these patients."
  • "The FDA's decision to grant a full approval for blinatumomab further validates the use of this therapy to treat adults and children with B-cell precursor ALL with MRD present following a remission, which is a strong predictor of relapse in this patient population."