Amgen faces Tavneos trial retraction as analysts debate outlook

Amgen stock trades near the upper $350s on Nasdaq as a pivotal Tavneos study is retracted by a leading medical journal after FDA findings, while Wall Street price targets for the biotech point to sizable upside from current levels.

By Thomas Clarke, Operations & Strategy desk. Reviewed on June 30, 2026 at 2:51 p.m. ET.

Amgen Inc. (ISIN US0311621009) is navigating a fresh regulatory and scientific challenge around its rare-disease drug Tavneos while Amgen stock trades on Nasdaq in the upper $350s per share, based on recent market data for ticker AMGN.

Tavneos trial retracted after FDA probe

A key catalyst for Amgen this week is the retraction of a pivotal Tavneos clinical trial article by the New England Journal of Medicine following findings by the U.S. Food and Drug Administration (FDA). According to a Reuters report carried by Yahoo News, the journal retracted the 2021 study that supported Tavneos approval after two academic authors requested the move.

The journal cited an FDA investigation that found outcome data for nine patients had been altered after the study database was finalized and that some researchers were unblinded, meaning they were told which patients received Tavneos and which did not. These changes were not disclosed in the published article, which the journal described as inconsistent with proper research conduct, increasing scrutiny on the integrity of the original trial.

Regulators question Tavneos benefit-risk profile

The FDA’s Center for Drug Evaluation and Research has already proposed withdrawing Tavneos approval, citing a lack of proven effectiveness and false statements in the original application, according to the same Reuters-backed coverage. The agency identified 76 cases of drug-induced liver injury with evidence suggesting a causal link to Tavneos, including seven cases of vanishing bile duct syndrome, a rare condition that can cause permanent liver damage, and eight deaths among those cases.

Europe’s drug regulator recently recommended revoking the marketing authorization for Tavneos, aligning with U.S. concerns over data integrity in the pivotal trial. Amgen has engaged a research firm to independently review the Tavneos data as it prepares for a hearing with the FDA, signaling that management is seeking to defend the drug’s benefit-risk profile despite the retraction and withdrawal proposals.

Consensus targets point to upside

While Tavneos faces regulatory pressure, Wall Street’s medium-term view on Amgen’s earnings and share price remains constructive. According to consensus data compiled by Bitget, the median 12-month price target for AMGN as of June 30, 2026 stands at $573.57, based on forecasts from global investment institutions and analysts, including those on Wall Street.

The same source reports a projected price range between $295.34 and $797.92 over the next year, illustrating a wide dispersion of views on how Amgen will trade. Bitget’s compilation shows that the overall consensus rating over the past three months is listed as Hold, though the underlying distribution is mixed with Buy, Hold and Sell recommendations. For investors, that divergence underscores uncertainty around regulatory outcomes, pipeline performance and the sustainability of recent earnings beats.

Recent earnings and guidance frame expectations

Amgen’s recent quarterly numbers offer context for why analysts see room for value creation even as Tavneos risk rises. As summarized by MarketBeat’s Amgen overview, the company reported earnings per share of $5.15 in its last quarter, beating the consensus estimate of $4.77 by $0.38.

MarketBeat notes that Amgen’s quarterly revenue rose 5.8 percent year-over-year, reflecting growth in its broader portfolio. The same source indicates that Amgen has set full-year 2026 guidance in a range between $21.70 and $23.10 in earnings per share, providing a framework for analysts’ forward models. That EPS guidance, combined with revenue projections cited by Bitget of around $9.43 billion for the next quarter, shapes expectations for cash generation and balance-sheet flexibility.

Ownership shifts and dividend track record

Institutional flows illustrate how some professional investors are repositioning after the latest information. A recent filing analyzed by MarketBeat’s instant alert service shows that Forum Financial Management LP lowered its Amgen stake by 0.8 percent during the first quarter, selling 2,792 shares.

The same alert points out that Amgen continues to be covered by a broad analyst base, with a consensus rating described as Hold and a consensus target price reported at around $354.42. Amgen also has an established dividend track record, with MarketBeat listing a recent dividend payable on June 5, 2026, following record and ex-dividend dates on May 15, 2026, indicating ongoing capital returns alongside regulatory uncertainty.

Representative product: Tavneos in rare disease

Tavneos itself is a representative example of Amgen’s focus on serious immune and rare diseases. The drug was approved to treat certain forms of ANCA-associated vasculitis, a group of rare autoimmune conditions that can damage small blood vessels and organs such as the kidneys. The retracted New England Journal of Medicine study provided pivotal data supporting that indication, making its withdrawal significant for clinicians and regulators assessing the therapy.

As described in the Reuters-backed reporting, regulators are now weighing Tavneos safety signals, notably cases of drug-induced liver injury and vanishing bile duct syndrome, against any benefits observed in the original trial program. Amgen’s decision to commission an independent review aims to reaffirm the drug’s benefit-risk balance, but the retraction and regulatory recommendations highlight the importance of robust, transparent trial conduct for complex medicines targeting narrow patient populations.

Amgen stock price snapshot

For a current market snapshot, several portals show Amgen trading close to the high $350s. TradingKey lists a recent closing price of $360.55 for AMGN as of June 29, 2026 at 4:00 p.m. ET, with a market capitalization around $194.59 billion and a trailing price-to-earnings ratio near 24.89, based on its latest data. Public’s options chain overview similarly cites a spot price of $360.55, up $2.22 or 0.62 percent on the day of its snapshot.

Bitget’s forecast page indicates that AMGN closed its last trading day at $358.33, a 1.56 percent daily gain, underscoring that the stock is currently trading well below the median one-year target yet within the spectrum of analyst expectations. As of June 30, 2026 at roughly 2:51 p.m. ET, these data points collectively suggest that Amgen is valued by the market as a large-cap biotech with meaningful regulatory headline risk but solid earnings and cash-flow guidance.

Amgen at a glance

• Company: Amgen Inc.
• ISIN: US0311621009
• Ticker: AMGN
• Exchange: Nasdaq
• Price (as of June 29, 2026, 4:00 p.m. ET): $360.55 USD
• Market cap: $194.59 billion (as of June 29, 2026)
• Sector / Industry: Health care - Biotechnology
• Index membership: Nasdaq-100
• Next earnings date: August 4, 2026 (estimated)

This article was generated automatically and technically reviewed before publication. Market prices, analyst data and company information are provided without warranty and may change at short notice. This content is for informational purposes only and is not investment, financial, legal or tax advice. It is not a recommendation to buy or sell any security. Investing in securities involves risk, including the possible loss of principal.