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AMGN's Subcutaneous Tepezza Scores Phase III Win in Thyroid Eye Disease
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Key Takeaways
AMGN reports Phase III success for subcutaneous Tepezza with 77% proptosis response vs ~20% placebo.
Amgen says SC Tepezza matches IV efficacy and can be delivered in minutes versus 90-minute infusions.
VRDN shares fell 26% as its 54% response rate lagged Tepezza's stronger study results.
Amgen (AMGN - Free Report) announced positive top-line results from a late-stage study evaluating the subcutaneous (under the skin or SC) formulation of its blockbuster drug Tepezza (teprotumumab) in patients with moderate-to-severe active thyroid eye disease (TED).
The study met its primary endpoint — about 77% of patients who received the SC dose of the drug via an on-body injector for 24 weeks achieved a statistically significant and clinically meaningful proptosis response rate compared to nearly 20% in the placebo group. The study achieved several key secondary endpoints, including a mean proptosis reduction of 3.17 mm versus 0.80 mm observed in the placebo group. Full data from this study is expected at a future medical meeting.
Amgen noted that the efficacy of Tepezza SC was comparable to the currently approved intravenous (IV) formulation, which remains the first and only approved therapy for TED. This supports the potential for a more convenient administration option that could expand patient access and drive broader adoption.
A key advantage offered by the SC version is improved patient convenience. Delivering a drug SC instead of IV can significantly reduce administration time. Per Amgen, the SC version can be administered to patients in minutes compared with the IV formulation that takes up to 90 minutes. This could ease the burden on healthcare facilities and improve treatment accessibility.
Amgen did not disclose any timeline for potential regulatory filings for Tepezza SC, leaving uncertainty around its path to market.
AMGN Stock Performance
Year to date, shares of Amgen have gained nearly 5% compared with the industry‘s 0.4% growth.
Image Source: Zacks Investment Research
More on Amgen’s Tepezza
Tepezza is part of Amgen’s rare disease franchise and was added to its portfolio following the acquisition of Horizon Therapeutics for about $28 billion in 2023. The deal added other rare disease drugs like Uplizna and Krystexxa to the company’s portfolio of marketed drugs.
Since the acquisition, Tepezza has become a key revenue generator for Amgen. The drug contributed $1.9 billion to the company’s topline, up 3% year over year. This growth was driven by higher volumes and pricing, partially offset by lower inventory levels and unfavorable changes in estimated sales deductions.
Why Did VRDN Stock Fall Post Amgen’s Announcement?
Following Amgen’s update, shares of Viridian Therapeutics (VRDN - Free Report) declined 26% on Wednesday. The move came despite Viridian recently reporting phase III data from the REVEAL-1 study evaluating elegrobart, its investigational IGF-1R antibody, in patients with active TED. While the study met its primary endpoint, the proptosis responder rate was 54%.
Investors largely focused on the apparent gap versus Tepezza’s 77% response rate, with some viewing Amgen’s therapy as the more effective option. Cross-study comparisons remain imperfect, as Viridian’s regimen involves fewer dose administrations, which could offer a convenience advantage.
Separately, the FDA is reviewing Viridian’s regulatory filing seeking approval for veligrotug in the TED indication. A final decision is expected by June 30. A potential approval could serve as a key catalyst for the company, which currently has no marketed products.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have risen from $2.55 to $2.87, while those for 2027 have increased from $2.85 to $3.25. CPRX shares have risen 7% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 EPS have increased from $8.14 to $8.99, while those for 2027 have risen from $9.25 to $10.10. The stock has declined 2% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.
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AMGN's Subcutaneous Tepezza Scores Phase III Win in Thyroid Eye Disease
Key Takeaways
Amgen (AMGN - Free Report) announced positive top-line results from a late-stage study evaluating the subcutaneous (under the skin or SC) formulation of its blockbuster drug Tepezza (teprotumumab) in patients with moderate-to-severe active thyroid eye disease (TED).
The study met its primary endpoint — about 77% of patients who received the SC dose of the drug via an on-body injector for 24 weeks achieved a statistically significant and clinically meaningful proptosis response rate compared to nearly 20% in the placebo group. The study achieved several key secondary endpoints, including a mean proptosis reduction of 3.17 mm versus 0.80 mm observed in the placebo group. Full data from this study is expected at a future medical meeting.
Amgen noted that the efficacy of Tepezza SC was comparable to the currently approved intravenous (IV) formulation, which remains the first and only approved therapy for TED. This supports the potential for a more convenient administration option that could expand patient access and drive broader adoption.
A key advantage offered by the SC version is improved patient convenience. Delivering a drug SC instead of IV can significantly reduce administration time. Per Amgen, the SC version can be administered to patients in minutes compared with the IV formulation that takes up to 90 minutes. This could ease the burden on healthcare facilities and improve treatment accessibility.
Amgen did not disclose any timeline for potential regulatory filings for Tepezza SC, leaving uncertainty around its path to market.
AMGN Stock Performance
Year to date, shares of Amgen have gained nearly 5% compared with the industry‘s 0.4% growth.
Image Source: Zacks Investment Research
More on Amgen’s Tepezza
Tepezza is part of Amgen’s rare disease franchise and was added to its portfolio following the acquisition of Horizon Therapeutics for about $28 billion in 2023. The deal added other rare disease drugs like Uplizna and Krystexxa to the company’s portfolio of marketed drugs.
Since the acquisition, Tepezza has become a key revenue generator for Amgen. The drug contributed $1.9 billion to the company’s topline, up 3% year over year. This growth was driven by higher volumes and pricing, partially offset by lower inventory levels and unfavorable changes in estimated sales deductions.
Why Did VRDN Stock Fall Post Amgen’s Announcement?
Following Amgen’s update, shares of Viridian Therapeutics (VRDN - Free Report) declined 26% on Wednesday. The move came despite Viridian recently reporting phase III data from the REVEAL-1 study evaluating elegrobart, its investigational IGF-1R antibody, in patients with active TED. While the study met its primary endpoint, the proptosis responder rate was 54%.
Investors largely focused on the apparent gap versus Tepezza’s 77% response rate, with some viewing Amgen’s therapy as the more effective option. Cross-study comparisons remain imperfect, as Viridian’s regimen involves fewer dose administrations, which could offer a convenience advantage.
Separately, the FDA is reviewing Viridian’s regulatory filing seeking approval for veligrotug in the TED indication. A final decision is expected by June 30. A potential approval could serve as a key catalyst for the company, which currently has no marketed products.
AMGN’s Zacks Rank
Amgen currently carries a Zacks Rank #3 (Hold).
Amgen Inc. Price
Amgen Inc. price | Amgen Inc. Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Catalyst Pharmaceuticals (CPRX - Free Report) and ANI Pharmaceuticals (ANIP - Free Report) . While CPRX sports a Zacks Rank #1 (Strong Buy) at present, ANIP carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have risen from $2.55 to $2.87, while those for 2027 have increased from $2.85 to $3.25. CPRX shares have risen 7% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ANI Pharmaceuticals’ 2026 EPS have increased from $8.14 to $8.99, while those for 2027 have risen from $9.25 to $10.10. The stock has declined 2% year to date.
ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.