Amgen Secures EU Nod for Imdylltra in Lung Cancer Indication

Amgen AMGN announced that the European Commission (“EC”) has approved Imdylltra (tarlatamab) to treat adults with extensive-stage small cell lung cancer (“SCLC”) who require systemic therapy following disease progression on or after first-line platinum-based chemotherapy.The EC decision is based on results from the phase III DeLLphi-304 study, which showed that treatment with the drug reduced the risk of death by 40% and also significantly extended the median overall survival by more than five months compared with standard of care.The drug is already approved for a similar indication in the United States, where it is marketed under the brand name Imdelltra. While the drug was initially approved in May 2024 under the accelerated pathway, it secured full approval last year, also supported by data from the DeLLphi-304 study.AMGN Stock PerformanceYear to date, shares of Amgen have gained nearly 1% compared with the industry‘s nil growth.Image Source: Zacks Investment ResearchMore on Amgen’s Imdelltra/ImdylltraImdelltra, or Imdylltra, is a bispecific T-cell engager therapy designed to target and destroy DLL3-expressing SCLC cells. Since its commercial launch, the drug has emerged as a key growth driver for Amgen. In the first quarter of 2026, Imdelltra generated sales of $258 million, up 219% year over year and 10% sequentially, driven primarily by volume growth.The newly secured EU approval is expected to meaningfully expand Imdelltra's commercial opportunity by opening access to additional patients across Europe. Reflecting this growth potential, the Zacks Consensus Estimate projects 2026 sales of the drug at about $1.2 billion, nearly double of $627 million generated in 2025, highlighting the drug's blockbuster potential.Several phase III studies are currently evaluating Imdelltrain earlier-line settings across both extensive-stage and limited-stage SCLC. Given the limited treatment options available for patients with SCLC, successful expansion into earlier treatment settings could further increase the drug's addressable market and support long-term sales growth.AMGN’s Zacks RankAmgen currently carries a Zacks Rank #3 (Hold).Amgen Inc. Price  Amgen Inc. price | Amgen Inc. QuoteKey Picks Among Biotech StocksSome better-ranked stocks from the sector are Immunocore IMCR and Indivior Pharmaceuticals INDV, each currently sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.Over the past 30 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents. Over the same period, estimates for 2027 EPS have risen from 24 cents to 87 cents. IMCR’s shares have lost 16% year to date.Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%.Over the past 30 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.00 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.33. INDV’s shares are down 3% year to date.Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%.Zacks' Research Chief Names "Stock Most Likely to Double"Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest.This top pick is a little-known satellite-based communications firm. Space is projected to become a trillion dollar industry, and this company's customer base is growing fast. Analysts have forecasted a major revenue breakout in 2025. Of course, all our elite picks aren't winners but this one could far surpass earlier Zacks' Stocks Set to Double like Hims & Hers Health, which shot up +209%.Free: See Our Top Stock And 4 Runners UpThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks