Amgen (AMGN): TAVNEOS approval withdrawal proposed; $2.2B intangible at risk
FDA proposed withdrawing TAVNEOS approval; $2.2B US intangible carried on books. No buybacks YTD, $6.8B authorization left.
What this filing says
Amgen's quarterly report says the FDA's drug center proposed on April 27, 2026 to withdraw approval of TAVNEOS, after an alert about serious liver injury cases, including fatal ones. The U.S. developed-product-technology intangible tied to the drug carried a value of $2.2 billion at September 30, 2026, so a withdrawal would matter to shareholders through that asset. The filing also reports lower amortization and operating expenses, while other revenues rose.
Key figures
- TAVNEOS intangible carrying value
- $2.2 billion
- Amortization, three months ended Sept 30, 2026
- $889 million
- Amortization, nine months ended Sept 30, 2026
- $2.7 billion
- Remaining stock repurchase authorization
- $6.8 billion
- Shares outstanding as of Oct 29, 2026
- 540,911,490 shares
- Other revenues increase, nine months
- 27%
Positive for shareholders
- Other revenues rose 27% for the nine months, driven by higher royalty income and corporate partner revenue.
- Operating expenses fell 7% for the nine months, reflecting lower acquisition-related amortization.
Negative for shareholders
- The FDA proposal to withdraw TAVNEOS approval, if carried out, could affect the $2.2 billion intangible asset tied to the drug.
- The FDA alerted patients and providers to serious liver injury, including fatal cases, associated with TAVNEOS.
- Amgen did not repurchase any shares during the nine months, and buybacks remain paused.
Written by Quantisnow AI from this filing. Not financial advice.
Key terms
- CDER:
- The FDA's Center for Drug Evaluation and Research, which reviews and oversees approved medicines.
- DILI:
- Drug-induced liver injury, liver damage caused by a medicine.
- Developed-product-technology rights:
- An intangible asset representing the value of an acquired, already-approved product and its technology.
- Finite-lived intangible assets:
- Acquired assets such as patents or product rights that lose value over a set period and are expensed through amortization.
FAQ
What is the FDA proposing for Amgen's TAVNEOS?
The FDA's drug center proposed on April 27, 2026 to withdraw approval of TAVNEOS, citing new information on effectiveness and alleged untrue statements in the application that led to approval.
How much is TAVNEOS worth on Amgen's balance sheet?
The filing states the U.S. developed-product-technology intangible asset for TAVNEOS has a carrying value of $2.2 billion as of September 30, 2026.
Historical context for AMGN
Across the 19 sessions after earlier AMGN headlines, the stock closed higher 11 times and lower 8 times, with a median move of 1.2% in either direction. This shows timing only: many things move a stock in a session, and these figures do not show that any headline caused a move.
| Session | Earlier headline | AMGN | SPY |
|---|---|---|---|
| Nov 4, 2026 | AMGEN REPORTS THIRD QUARTER 2026 FINANCIAL RESULTS | +3.7% | +1.7% |
| Oct 29, 2026 | AMGEN ANNOUNCES WEBCAST OF 2026 THIRD QUARTER FINANCIAL RESULTS | +2.0% | -0.4% |
| Oct 28, 2026 | AMGEN ANNOUNCES 2026 FOURTH QUARTER DIVIDENDand 1 other headline that session | +0.9% | +0.3% |
| Oct 27, 2026 | AMGEN APPOINTS DAVID W. GIBBS TO BOARD OF DIRECTORS | +0.7% | +0.6% |
| Oct 26, 2026 | FDA Approval for PAVBLU issued to AMGEN INCand 1 other headline that session | +1.2% | +0.7% |
| Oct 23, 2026 | FDA Approval for PAVBLU issued to AMGEN INC | -1.8% | -0.5% |
Keep researching AMGN
- AMGN financial statementsRevenue, profit, cash flow and balance sheet from Amgen Inc.'s SEC filings.
- What is Form 10-Q?The quarterly report US public companies file with the SEC for each of the first three fiscal quarters, with unaudited financial statements and MD&A.
- Form 10-K vs 10-QThe difference between a 10-K and a 10-Q: what each report contains, filing deadlines by company size, audited vs reviewed financials, and which sections to read first.
- AMGN insider tradesEvery buy and sale reported by Amgen Inc. officers, directors and large holders.
- AMGN earnings historyPast Amgen Inc. earnings releases, newest first.
- AMGN dividend historyDividends Amgen Inc. has declared, with ex-dates and payment dates.
- Market cap
- 30-day
- Sector
- Health Care
- Industry
- Biotechnology: Biological Products (No Diagnostic Substances)
- Listed since
- 1983
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