Workspaces
Log in Sign up

Amgen Confirms Expansion of MariTide Phase 3 Program to 12 Trials by Year-End, Emphasizing Ultra-Low Dosing Frequency

Updated

Sources

Amgen Confirms Expansion of MariTide Phase 3 Program to 12 Trials by Year-End, Emphasizing Ultra-Low Dosing Frequency

At the Goldman Sachs 47th Annual Global Healthcare Conference, Amgen Inc. (NASDAQ: AMGN) executives delivered a comprehensive corporate update, showcasing the aggressive expansion of its phase 3 MARITIME clinical trial program for MariTide (AMG 133). In addition to its clinical pipeline, Amgen is navigating a major financial catalyst in the U.S. Tax Court, which recently achieved a key procedural milestone.

Amgen's $10.7B+ IRS Transfer Pricing Dispute Reaches Trial Completion

Amgen has been locked in a massive transfer pricing dispute with the Internal Revenue Service (IRS) regarding the allocation of profits between its U.S. parent and its manufacturing subsidiary in Puerto Rico for the tax years 2010 through 2015. The IRS has proposed adjustments totaling over $10.7 billion in back taxes and penalties.

On June 12, 2026, U.S. Tax Court Judge Travis A. Greaves issued an order granting Amgen's motion to unseal the simultaneous sur-reply briefs filed by both Amgen and the IRS on May 20, 2026 (docket numbers 16017-21 and 15631-22).

  • Significance: Unsealing these briefs marks the official completion of the briefing phase of the trial. The case is now fully ripe for a final Tax Court ruling.
  • Financial Impact: A ruling consistent with Amgen's tax reserves would remove a massive discount overhang on the stock, while an adverse ruling could materially impact Amgen's financial statements and trigger further disputes for the subsequent 2016–2022 tax periods. A final ruling is widely anticipated in the second half of 2026 (H2 2026).

MariTide Phase 3 Expansion Updates

MariTide is an investigational bispecific molecule that acts as a GIP receptor antagonist and a GLP-1 receptor agonist. Its primary competitive differentiator is its ultra-low dosing frequency (monthly or bimonthly subcutaneous injections)1, which contrasts with the weekly dosing required for Eli Lilly's Zepbound and Novo Nordisk's Wegovy.

Amgen confirmed that the Phase 3 MARITIME program is on track to expand to 12 clinical trials by the end of 2026. This expansion will evaluate MariTide's safety, efficacy, and tolerability across a broad range of indications, including chronic weight management, type 2 diabetes, cardiovascular risk reduction, and obstructive sleep apnea.

Verbatim Quotes

"ORDERED that petitioner's Motion to Unseal Simultaneous Sur-Reply Briefs, filed June 10, 2026, is granted. It is further ORDERED that petitioner's Simultaneous Sur-Reply Brief... and respondent's Simultaneous Sur-Reply Brief... are no longer sealed." — Judge Travis A. Greaves, U.S. Tax Court Order, June 12, 2026

"Amgen Inc. and the IRS have sharpened their competing transfer pricing theories in simultaneous sur-reply briefs filed with the U.S. Tax Court..." — Tax Notes, June 2026

  1. An instance of Daily weight-loss pills cannot outcompete the extreme convenience of once-monthly injections. — Clinical progression toward monthly or bimonthly formulations highlights the market's focus on long-acting convenience over daily administration. ↩︎

Part of

This finding is an example of a pattern recurring across your work:

Revision history

  • Update Amgen's corporate note to document the June 12, 2026 Tax Court unsealing of simultaneous sur-reply briefs, signifying the completion of the briefing phase of the $10.7B+ IRS transfer pricing dispute and setting the stage for a final ruling in H2 2026.
    · by the agent
  • Updated without a stated reason.
    · by the agent
  • Document Amgen's Phase 2 MariTide clinical data and the launch of the Phase 3 MARITIME program, providing financial context.
    · by the agent
  • Document Amgen's Phase 2 MariTide clinical data and the launch of the Phase 3 MARITIME program, providing financial context.
    · by the agent
  • Document Amgen's Phase 2 MariTide clinical data and the launch of the Phase 3 MARITIME program, providing financial context.
    · by the agent
  • Document Amgen's Phase 2 MariTide clinical data and the launch of the Phase 3 MARITIME program, providing financial context.
    · by the agent