Amgen stock gains as FDA eases Imdelltra monitoring burden

Published on 09/15/2026 at 14:42 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Amgen stock trades near USD 381 on Nasdaq as of September 14, 2026 after the FDA approved shorter monitoring times for its lung-cancer drug Imdelltra. The move reshapes the risk-reward view around Amgen stock amid recent volatility tied to Lp(a) trial setbacks.

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Amgen Inc. stock (ISIN US0311621009) closed at USD 381.96 on Nasdaq on September 14, 2026, up 1.1 percent from the previous session as investors digested a key U.S. Food and Drug Administration decision on the company’s oncology portfolio.

FDA decision changes Imdelltra treatment dynamics

On September 14, 2026, Amgen announced that the U.S. Food and Drug Administration approved an update to the prescribing information for its bispecific T-cell engager therapy Imdelltra (tarlatamab-dlle), substantially reducing the recommended monitoring time for the first two doses in an appropriate healthcare setting, according to Amgen.

Under the revised guidance, patients receiving Imdelltra should now be monitored for 6 to 8 hours from the start of their first two infusions, compared with the previously recommended 22 to 24 hours, according to Amgen.

The change cuts monitoring time for the first two doses by roughly two-thirds and is accompanied by a follow-up assessment including vital signs on the day after each of these doses, while subsequent cycle recommendations remain in place, as outlined by Amgen.

Dividend profile and valuation frame investor sentiment

The FDA decision comes as income-oriented investors focus on Amgen’s dividend sustainability and valuation metrics. On September 14, 2026, analysis from GuruFocus highlighted that Amgen offers a dividend yield of 2.63 percent with a payout ratio of 44 percent and a three-year dividend growth rate of 7.1 percent, underscoring a steady income stream backed by earnings.

The same analysis assessed Amgen’s stock as modestly overvalued, noting that its GF Value metric stood at USD 366.02 compared with a referenced price of USD 377.35, implying a 3.1 percent premium to intrinsic value on that date, according to GuruFocus.

For investors, the combination of a mid-single-digit dividend growth rate and only a slight valuation premium framed Amgen as a relatively balanced income-and-growth play even as the stock faced volatility from recent clinical and rating developments.

Recent downgrades and Lp(a) trial setback weigh on the stock

While the Imdelltra update is a clear operational positive, the broader narrative around Amgen stock has recently been shaped by negative news in the lipoprotein(a), or Lp(a), drug class. On September 4, 2026, Novartis reported that its pelacarsen trial did not demonstrate cardiovascular benefit, raising questions about the entire Lp(a)-lowering category that includes Amgen’s investigational olpasiran, as summarized by Investing.com Italy.

In the wake of that setback, Amgen shares dropped as much as 10 percent on September 8, 2026, marking their weakest performance within the Dow that day, after BMO Capital downgraded the stock to Market Perform with a price target of USD 450, only days after Amgen had traded close to its 52-week high of USD 447.03, according to Investing.com Italy.

Commentary from Investing.com Australia on September 15, 2026, noted that Amgen was the worst-performing holding in one Dow-focused strategy over the September 1 to 15 window, with a 12.9 percent decline, even as the FDA’s Imdelltra decision provided a rare piece of good news against that broader rout.

The contrast between a supportive regulatory outcome for Imdelltra and lingering uncertainty around olpasiran’s commercial potential captures why Amgen stock is experiencing both defensive support from its dividend and valuation profile and pressure from pipeline-specific risk factors.

Market data and trading context for Amgen stock

Per Nasdaq price data reflected by a recent corporate-news overview, Amgen stock ended trading on Nasdaq at USD 381.96 on September 14, 2026, compared with a prior close around USD 378.70, translating into an approximate daily gain of 1.1 percent for that session.

According to a portfolio valuation snapshot cited by GuruFocus, the USD 377.35 price point used in its valuation comparison on September 14, 2026 stood around 3.1 percent above the GF Value estimate of USD 366.02, giving a concrete sense of how far the stock was trading above that intrinsic value gauge.

From a technical perspective, the reference to trading near a 52-week high of USD 447.03 around early September 2026 suggests Amgen shares were roughly 14.6 percent below that peak at the USD 381.96 close on September 14, 2026, indicating that the recent pullback has created some distance from the stock’s yearly high while still leaving it well above any implied 52-week low cited in strategy commentary.

Stock level as of the last completed trading day

As of the last completed trading day before publication, September 14, 2026, Amgen stock traded on Nasdaq as the primary listing venue, with the closing price of USD 381.96 in USD serving as the key reference point for investors assessing the impact of the FDA’s Imdelltra decision and the ongoing Lp(a) debate.