FDA reduces monitoring time for Amgen’s Imdelltra infusions

Amgen (AMGN) is conducting a Phase 3 trial comparing romiplostim plus prednisone against prednisone alone for newly diagnosed primary immune thrombocytopenia. The study aims to improve platelet control and reduce steroid exposure. A positive result could expand romiplostim's market and strengthen Amgen's hematology portfolio. The trial is ongoing, with recruitment active.

Amgen faces a lawsuit over its proposed biosimilar version of Opdivo. The lawsuit alleges patent infringement, which could impact Amgen's plans. The case is ongoing, and the outcome may affect Amgen's market position in the biosimilar space.

Bristol Myers Squibb (BMY) and Ono Pharmaceutical sued Amgen (AMGN) to block its biosimilar version of Opdivo, alleging patent infringement. Opdivo generated $5.9B in U.S. sales last year. Amgen aims to be among the first Opdivo biosimilars, with FDA approval sought.

U.S. 10-year Treasury yields hit 5%, highest since 2007, ahead of Fed decision with 90% chance of a 25-basis-point hike. Investing.com's Mid-Cap Movers strategy gained 580.7% since 2013, outperforming S&P MidCap 400. Top performers include Commvault (CVLT, +8.5%), Insight Enterprises (NSIT, +5.0%), and Wingstop (WING, +4.7%). Lennox International (LII) downgraded to Hold, Amgen (AMGN) FDA approval for Imdelltra.

Amgen (AMGN) announced FDA approval to reduce monitoring time for the first two doses of IMDELLTRA (tarlatamab-dlle) from 22-24 hours to 6-8 hours. The change aims to ease treatment burdens for ES-SCLC patients and simplify administration. AMGN stock is currently at $377.40, up 0.01%.

Novartis' pelacarsen failed to meet its primary endpoint in a late-stage study, impacting the cardiovascular drug market. Analysts expected peak sales of $4B-$5B. Eli Lilly's (LLY) stock declined only 3%, as its lepodisiran drug uses a different approach and Lilly has strong diabetes/obesity markets. Novartis (NVS) and Amgen (AMGN) are also developing Lp(a)-lowering drugs.