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Amgen Rocatinlimab's Data Shows Potential As Long-Term Therapy For Atopic Dermatitis - Amgen (NASDAQ:AMGN)

Rocatinlimab showed sustained therapeutic benefits and a low discontinuation rate due to adverse events in about 2,600 patients treated for up to two and a half years, Amgen and Kyowa Kirin reported.

  • On September 8, 2025, Amgen and Kyowa Kirin released initial top-line findings from the ASCEND trial, which is assessing rocatinlimab in a group of roughly 2,600 adolescent and adult participants experiencing significant symptoms of atopic dermatitis.
  • This announcement follows the June 1, 2021 collaboration where the companies agreed to jointly develop and commercialize rocatinlimab, an investigational anti-OX40 monoclonal antibody targeting T-cell imbalance, a key driver of atopic dermatitis.
  • The ASCEND trial evaluates the long-term safety and effectiveness of dosing every four or eight weeks following an initial 24-week treatment period, with patients continuing on monotherapy demonstrating sustained improvements in symptom control, itching, and overall disease involvement and intensity.
  • The most frequently reported adverse effects included infections of the upper respiratory tract, mouth sores, headaches, flu-like symptoms, coughing, and nasal inflammation. Additionally, gastrointestinal ulceration occurred at a rate below one event per 100 patient-years, and few patients discontinued treatment due to side effects.
  • These findings represent a key advancement in understanding the therapeutic potential of rocatinlimab for atopic dermatitis. Amgen and Kyowa Kirin intend to present comprehensive data at a forthcoming scientific meeting or publish it in a peer-reviewed journal.
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Albuquerque JournalAlbuquerque Journal
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AMGEN AND KYOWA KIRIN ANNOUNCE TOP-LINE RESULTS FROM ROCATINLIMAB PHASE 3 ASCEND LONG-TERM EXTENSION STUDY IN ADULTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

THOUSAND OAKS, Calif. and TOKYO, Sept. 8, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Kyowa Kirin Co., Ltd. (TSE: 4151) today announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor,…

·Albuquerque, United States
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PR Newswire broke the news in United States on Tuesday, September 9, 2025.
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