Amgen Inc.

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Bullish +75

Amgen reports positive Phase III findings for subcutaneous Tepezza trial

🏥 Amgen reported positive top-line results for its Phase III trial of subcutaneous Tepezza in adults with moderate-to-severe active thyroid eye disease (TED).

💉 The new subcutaneous formulation, delivered via an on-body injector (OBI), achieved efficacy comparable to the currently approved intravenous (IV) version.

📊 The trial met its primary endpoint, showing a statistically significant 77% proptosis response rate at 24 weeks compared to placebo.

📉 Secondary endpoints were also met, including an average proptosis reduction of 3.17mm and improvements in clinical activity scores and quality of life measures.

⚠️ While visual function showed a numerical trend favoring the drug, it did not reach statistical significance in this study.

🛡️ Safety outcomes for the subcutaneous formulation matched those of the IV version, with mild-to-moderate injection site reactions being manageable.

🤢 The most common adverse events observed included diarrhoea, ear discomfort, muscle spasms, nausea, tinnitus, and weight decrease.

👁️ Tepezza (teprotumumab-trbw) treats TED, a rare autoimmune disease causing proptosis, double vision, and other eye complications.

📋 The trial enrolled participants with moderate-to-severe TED within the previous 15 months who had at least 3mm of proptosis.

💊 Dosing involved administration every two weeks for 12 total doses using the on-body injector system.

🗣️ Jay Bradner, Amgen's executive vice-president of research and development, stated the results extend the best-in-class efficacy of Tepezza with a more convenient delivery method.

🚀 The subcutaneous option aims to potentially reach more patients by improving convenience compared to intravenous infusion.

📅 This news was updated on April 7, 2026, following initial Phase III findings from the ASCEND trial in September 2025.

🏢 Tepezza is developed by Amgen and Kyowa Kirin, focusing on rebalancing T-cells to treat autoimmune conditions.

Bullish Signals
  • Amgen reported positive top line results from its Phase III subcutaneous Tepezza trial for adults with moderate-to-severe active thyroid eye disease (TED).
  • The new subcutaneous formulation achieved efficacy comparable to the already approved intravenous Tepezza, delivering IV-level performance via a convenient on-body injector.
  • The trial met its primary endpoint with a statistically significant 77% proptosis response rate at 24 weeks.
  • Key secondary endpoints were also met, including an average reduction in proptosis of 3.17mm at week 24 and significant improvements in clinical activity score and quality of life.
  • Safety outcomes for the subcutaneous version matched the IV formulation, with mild-to-moderate injection site reactions that did not require interruption or stopping of treatment.
  • Executive Vice-President Jay Bradner noted these results extend and support the best-in-class efficacy of Tepezza, potentially reaching more patients through a more convenient delivery option.
  • In September 2025, Amgen also announced initial top line findings from the Phase III ASCEND trial for rocatinlimab in atopic dermatitis, showing ongoing innovation pipeline activity.
Risk Factors
  • Safety outcomes for subcutaneous Tepezza were limited to a numerical trend without statistical significance in visual function improvements, despite positive findings in other secondary endpoints.
  • The trial inclusion criteria restricted participation to patients with a diagnosis of moderate-to-severe TED within the previous 15 months and proptosis of 3mm or greater from baseline, potentially limiting generalizability to broader patient populations.
Full Analysis
Amgen has announced positive top-line results from a Phase III clinical trial evaluating subcutaneous Tepezza (teprotumumab-trbw), an intravenous therapy approved for treating moderate-to-severe active thyroid eye disease (TED). The study utilized an on-body injector (OBI) to deliver the drug subcutaneously, demonstrating efficacy comparable to the existing intravenous formulation. The trial met its primary endpoint by achieving a statistically significant 77% proptosis response rate at 24 weeks, with an average reduction in proptosis of 3.17mm at the same time point. Additional secondary endpoints were also successfully met, including improvements in overall responder rates, clinical activity scores, diplopia changes, and quality of life metrics related to Graves' Ophthalmopathy. Safety profiles for the subcutaneous formulation matched those of the intravenous version, with mild-to-moderate injection site reactions being manageable without requiring treatment interruption. Common adverse events included diarrhea, nausea, and muscle spasms. The trial enrolled patients diagnosed within the previous 15 months with significant proptosis who received dosing every two weeks for a total of 12 administrations. Jay Bradner, Amgen's executive vice-president for research and development, stated that these results support Tepezza as a best-in-class option, offering a more convenient delivery method to potentially reach a broader patient population. The findings represent a significant step forward for patients with this rare autoimmune condition by simplifying the administration process while maintaining established clinical benefits. This development is distinct from Amgen's other concurrent research, such as the ASCEND trial for atopic dermatitis announced in September 2025, and focuses specifically on optimizing the delivery mechanism for its established TED treatment.