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AMGN-News
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Gilead and Others Notable Gainers in Liquid Options This Morning
Notable gainers among liquid option names this morning include Gilead (GILD) $148.10 +3.88, NetApp (NTAP) $234.28 +5.83, Amgen (AMGN) $412.67 +10.07, Marathon Petroleum (MPC) $443.15 +10.79, and Kroger (KR) $59.70 +1.29.
Amgen Reports Positive Results for Sjogren's Drug
Amgen announced positive topline results from the Phase 3 OASIZ 301 study evaluating dazodalibep in adults with Sjogren's disease and moderate-to-severe systemic disease activity. The study met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement at Week 48, as measured by the EULAR Sjogren's Syndrome Disease Activity Index. Notably, improvements in ESSDAI were observed as early as Week 4 with treatment with dazodalibep, which were sustained through Week 48 of the study. ESSDAI is a validated clinical tool used to assess systemic disease activity across organ systems in patients with Sjogren's disease. The most common adverse events were nasopharyngitis, urinary tract infection, hypertension, and infusion-related reactions, and were generally mild to moderate in nature. Discontinuations due to adverse events occurred at a low rate and were balanced across treatment groups. No imbalance in the incidence of thromboembolic events or opportunistic infections was observed across treatment arms. The Phase 3 OASIZ 303 study of dazodalibep in moderate-to-severe symptomatic Sjogren's disease is expected to complete in Q4.
Amgen Deploys Veeva Vault CRM Globally
Veeva Systems (VEEV) announced that Amgen (AMGN) plans to deploy Veeva Vault CRM globally, building on a collaboration spanning more than a decade. "Moving to Vault CRM will help accelerate our efforts to bring new therapies to patients globally with greater speed and agility," said Scott Skellenger, senior vice president and chief information officer at Amgen. "Veeva's deep understanding of life sciences, its continued focus on innovation, and our long-standing collaboration will help support Amgen in achieving these important goals."
Amgen Receives FDA Approval to Shorten Imdelltra Monitoring Time
Amgen announced that the U.S. FDA approved an update to the imdelltra Prescribing Information that substantially reduces the recommended monitoring time for the first two doses of treatment in an appropriate healthcare setting. This approval means that patients receiving imdelltra should now be monitored for 6 to 8 hours from the start of their first two infusions, compared with the previously recommended 22 to 24 hours. Patients will also receive a follow-up assessment, including vital signs, the day after each of these first two doses. For people living with extensive-stage small cell lung cancer, the change could mean substantially less time spent in a healthcare setting during the initial treatment period. The updated requirement may also reduce treatment complexity for community oncology practices, where an estimated 80% to 85% of U.S. cancer patients receive care.
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