- Trial Phase
- Phase 1/2
- Time to Market
- AMG 732 is in Phase 1/2 with estimated primary completion in January 2027. If successful, Phase 3 trials would follow, meaning potential approval is likely several years away (likely 2029-2030 at the earliest), assuming positive data and continued development.
- Why 3/10
- The next hard catalyst is the estimated primary completion of the Phase 1/2 study around January 6, 2027 (~2 months away). However, AMG 732 is a Phase 1/2 asset at a mega-cap company (Amgen, ~$250B market cap) with dozens of marketed products and pipeline programs. Even a positive readout would have negligible impact on AMGN shares. The drug is a tiny fraction of Amgen's value, and Amgen already markets the leading TED drug Tepezza ($1.9B in 2025 revenue) with its own subcutaneous formulation in late-stage development.
The next catalyst for AMG 732 is the estimated primary completion of the Phase 1/2 study (NCT06401044) around January 6, 2027, which could yield topline safety and efficacy data. However, given Amgen's mega-cap size and deep pipeline, even positive data would have a negligible impact on AMGN shares. Investors should watch for any disclosure of Phase 1/2 results and whether Amgen advances the program to Phase 3, but the stock's thesis rests on far larger products (Tepezza, Enbrel, Prolia, Repatha, etc.).
Price Chart
Executive Summary
AMG 732 (formerly HZN-280) is an investigational monoclonal antibody targeting the insulin-like growth factor-1 receptor (IGF-1R), being developed by Amgen as a subcutaneous treatment for thyroid eye disease (TED). It is currently in a Phase 1/2 trial (NCT06401044) that is active but no longer recruiting, with estimated primary completion in January 2027. Preclinical data presented at ENDO 2026 showed AMG 732 has higher binding affinity to IGF-1R and more potent inhibition than Amgen's own approved TED drug Tepezza (teprotumumab), along with an extended half-life of about 22 days in monkeys. AMG 732 is a very early-stage asset within Amgen's massive pipeline and represents a tiny fraction of the company's value. Amgen already dominates the TED market with Tepezza ($1.9B in 2025 revenue) and is developing a subcutaneous formulation of Tepezza that recently posted positive Phase 3 results. No near-term binary catalyst exists for AMG 732 specifically.
How It Works
AMG 732 is a monoclonal antibody (a lab-made protein that mimics the immune system) designed to block and degrade the insulin-like growth factor-1 receptor (IGF-1R), a protein on cell surfaces that is overactive in thyroid eye disease. By inhibiting this receptor, the drug aims to reduce the inflammation, swelling, and tissue buildup behind the eyes that cause bulging and double vision in TED. It is designed to be given as a shot under the skin (subcutaneous injection), which is more convenient than the current standard IV infusion.
Trial Status
AMG 732 is being studied in a Phase 1/2 randomized, double-masked, placebo-controlled trial (NCT06401044) across 44 sites in 12 countries. The study has enrolled 94 participants and is active but no longer recruiting. Part A evaluates safety and tolerability after single doses in healthy volunteers; Part B evaluates efficacy in patients with moderate-to-severe active TED after multiple subcutaneous doses. A separate Phase 2 open-label rollover study (HAZEL 401, NCT07438405) is recruiting for patients who were non-responders or relapsed in the parent trial. Preclinical data presented at ENDO 2026 showed AMG 732 has roughly 13-fold higher binding affinity to IGF-1R than teprotumumab (Tepezza) and a monkey half-life of about 22 days.
The Two-Sided Case
Upcoming Catalysts
- Estimated primary completion of Phase 1/2 trial (NCT06401044) around January 6, 2027, which could yield topline safety and efficacy data
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Amgen PRESS-RELEASE AMGN ·Originating report