Amgen (AMGN) Stock News

Amgen (NASDAQ:AMGN) announced positive topline results from its Phase 3 FORTITUDE-101 clinical trial for bemarituzumab in gastric cancer treatment. The trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in overall survival (OS) when combining bemarituzumab with chemotherapy compared to placebo plus chemotherapy.

The study focused on patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) cancer with FGFR2b overexpression and non-HER2 positive status. This breakthrough is particularly significant given that gastric cancer is the fifth leading cause of cancer-related death worldwide, with nearly one million new cases and over 650,000 deaths annually.

The most common treatment-emergent adverse events included reduced visual acuity, punctate keratitis, anemia, neutropenia, nausea, corneal epithelium defect, and dry eye. Notably, ocular events occurred with greater frequency and severity in the bemarituzumab arm compared to the Phase 2 experience. A separate Phase 3 study combining bemarituzumab with chemotherapy and nivolumab is ongoing, with results expected in H2 2025.

Amgen announced positive Phase 2 results for MariTide (maridebart cafraglutide), a monthly obesity treatment. The drug achieved ~20% average weight loss in non-diabetic obese patients and ~17% in those with Type 2 diabetes after 52 weeks, significantly outperforming placebo. Notably, weight loss hadn't plateaued at study end, suggesting potential for further reduction. The drug demonstrated significant cardiometabolic improvements and HbA1c reduction up to 2.2% in diabetic patients. Safety profile aligned with GLP-1 class, with mainly mild to moderate gastrointestinal side effects. Lower starting doses improved tolerability without compromising efficacy. Amgen is advancing to Phase 3 MARITIME trials for chronic weight management, with additional studies planned for cardiovascular disease, heart failure, and sleep apnea in 2025.

Amgen will present key data for MariTide, its investigational monthly obesity and Type 2 diabetes treatment, at the American Diabetes Association's 85th Scientific Sessions. The presentation will showcase 52-week efficacy and safety data from Phase 2 studies, showing significant weight loss without plateauing in patients with and without Type 2 diabetes. MariTide represents a breakthrough as the first monthly or less frequently dosed peptide-antibody conjugate for obesity treatment. The company will also present new Repatha data regarding lipid-lowering therapy benefits in Type 1 diabetes patients. Amgen will host an investor webcast on June 23, 2025, at 4:30 p.m. CDT to discuss the MariTide program. The scientific sessions will feature additional presentations on cardiovascular efficacy and lipid-lowering therapy patterns from the FOURIER and VESALIUS-REAL studies.

Amgen (AMGN) has launched 'The Making of a Heart Attack', a documentary featuring football legend Barry Sanders, who reveals his personal heart attack experience from Father's Day 2024. The documentary aims to raise awareness about high LDL (bad) cholesterol as a major risk factor for cardiovascular events. Sanders joins other cardiovascular disease survivors and medical experts to educate viewers about the dangers of high LDL-C, noting that over 40% of U.S. adults with high LDL-C are unaware of their condition. The documentary is part of Amgen's initiative to reduce heart attacks and strokes in the U.S. by half by 2030. The film will premiere on A&E on June 14, 2025, and will be available online at AttackHeartDisease.com/Documentary from June 16, 2025.

Amgen (NASDAQ: AMGN) has announced its participation in the Goldman Sachs 46th Annual Global Healthcare Conference on June 10, 2025, at 9:20 a.m. PT. The company will be represented by Peter Griffith, EVP and CFO, and Jay Bradner, EVP of Research and Development. The presentation will be accessible through a live webcast on Amgen's website (www.amgen.com) under the Investors section. The webcast will remain available for replay for at least 90 days following the event, along with other selected management presentations from investor and medical conferences.

Amgen's IMDELLTRA (tarlatamab-dlle) demonstrated remarkable results in the Phase 3 DeLLphi-304 trial for small cell lung cancer (SCLC) treatment. The drug reduced death risk by 40% and extended median overall survival to 13.6 months versus 8.3 months with standard chemotherapy. The trial met both primary overall survival and secondary progression-free survival endpoints. IMDELLTRA showed superior safety profile with lower rates of grade 3+ treatment-related adverse events (27% vs 62%) and fewer discontinuations (3% vs 6%) compared to standard care. The drug also improved patient-reported outcomes for cancer-related symptoms. These results, presented at ASCO 2025 and published in The New England Journal of Medicine, support IMDELLTRA's potential as a transformative second-line treatment for SCLC patients who progressed after platinum-based chemotherapy.

Amgen (NASDAQ:AMGN) has announced its participation in the upcoming Jefferies Global Healthcare Conference on June 4, 2025, at 9:20 a.m. ET. The company will be represented by Peter Griffith, EVP and CFO, and Murdo Gordon, EVP of Global Commercial Operations. The presentation will be accessible via a live webcast on Amgen's website (www.amgen.com) under the Investors section. The webcast recording will remain available for replay for at least 90 days following the event. This presentation is part of Amgen's ongoing investor relations activities where management discusses company developments at various investor and medical conferences.

Amgen (NASDAQ:AMGN) has announced its participation in the 2025 RBC Capital Markets Global Healthcare Conference. Kave Niksefat, senior vice president of Global Marketing and Access, will represent the company at the event scheduled for Wednesday, May 21, 2025, at 9:00 a.m. ET.

The presentation will be accessible via webcast to investors, media, and the general public through Amgen's website (www.amgen.com) under the Investors section. The webcast recording will remain available for replay for a minimum of 90 days following the event.

Amgen (NASDAQ:AMGN) has announced its participation in the upcoming Bank of America Merrill Lynch Global Healthcare Conference on May 14, 2025, at 9:20 a.m. PT. The company will be represented by Peter Griffith, executive vice president and CFO, and Jay Bradner, executive vice president of R&D and chief scientific officer.

The presentation will be accessible through a live webcast on Amgen's website (www.amgen.com) under the Investors section. The webcast recording will remain available for replay for at least 90 days following the event.