⚠ The FDA's Withdrawal ProposalHigh threat

Amgen (AMGN) — threat to the moat

The FDA has proposed withdrawing TAVNEOS, and $2.4 billion of intangible assets depends on the hearing.

Most threats to a drug are commercial. This one is regulatory, and it is binary. The FDA asked Amgen in January 2026 to withdraw TAVNEOS; Amgen refused1. The FDA's drug centre then proposed on 27 April 2026 to withdraw approval, published a notice on 30 April, and Amgen requested a hearing on 1 June and submitted its materials on 23 July2.

The TAVNEOS proceeding16 Jan2026FDA asks forvoluntary withdrawal28 Jan2026Amgendeclines27 Apr2026withdrawalproposed1 Jun 2026hearingrequested23 Jul 2026materialssubmitted30 Jun2026intangiblecarried at $2.4bnAmgen Form 10-K FY2025 and Form 10-Q Q2 2026
Five steps toward a decision.

A proposal to withdraw an approved drug against the company's wishes is unusual. It means the agency has concluded that the evidence behind the original approval no longer supports it, and it forces the company to defend its data in a formal proceeding.

Amgen's exposure is on the balance sheet. The TAVNEOS intangible was carried at $2.4 billion at 30 June 2026, $2.3 billion of it for the United States3. The drug sold $459 million in 20254, so the carrying value is about five years of current sales.

There is a reputational cost too. Amgen's case for its acquisitions rests on judging which drugs will last. A purchase whose core product is withdrawn by the regulator four years after the deal weakens that case, even if the dollar loss is small against a company of Amgen's size.

The decision after the hearing settles it. If the FDA withdraws approval, expect a write-off close to the $2.3 billion American share of the intangible5; if the hearing preserves the approval, the risk falls away and TAVNEOS resumes its growth.

References
  1. ReportedThe FDA asked Amgen in January 2026 to withdraw TAVNEOS; Amgen refused.
    Amgen Form 10-K for fiscal 2025 - Item 1A risk factors, government pricing and legal proceedings including the IRS dispute. — FY2025 · publ. 13 February 2026 · source ↗
  2. ReportedThe FDA's drug centre then proposed on 27 April 2026 to withdraw approval, published a notice on 30 April, and Amgen requested a hearing on 1 June and submitted its materials on 23 July.
    Amgen Form 10-Q for the quarter ended 30 June 2026 - product sales, the TAVNEOS proceeding, the IRS dispute, the BeOne stake and the balance sheet. — Q2 2026 · publ. 5 August 2026 · source ↗
  3. ReportedThe TAVNEOS intangible was carried at $2.4 billion at 30 June 2026, $2.3 billion of it for the United States.
    Amgen Form 10-Q for the quarter ended 30 June 2026 - product sales, the TAVNEOS proceeding, the IRS dispute, the BeOne stake and the balance sheet. — Q2 2026 · publ. 5 August 2026 · source ↗
  4. ReportedThe drug sold $459 million in 2025, so the carrying value is about five years of current sales.
    Amgen fourth-quarter and full-year 2025 results release, Form 8-K exhibit 99.1 - product sales for 2024-2025, non-GAAP EPS and 2026 guidance. — FY2025 · publ. 3 February 2026 · source ↗
  5. ReportedIf the FDA withdraws approval, expect a write-off close to the $2.3 billion American share of the intangible; if the hearing preserves the approval, the risk falls away and TAVNEOS resumes its growth.
    Amgen Form 10-Q for the quarter ended 30 June 2026 - product sales, the TAVNEOS proceeding, the IRS dispute, the BeOne stake and the balance sheet. — Q2 2026 · publ. 5 August 2026 · source ↗
Sources
Generated September 28, 2026