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Amgen Secures EU Nod for Imdylltra in Lung Cancer Indication
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Key Takeaways
Amgen secured EU approval for Imdylltra in extensive-stage SCLC after prior platinum-based chemotherapy.
Imdylltra cut death risk by 40% and extended median overall survival by more than five months.
Imdylltra posted $258M in Q1 2026 sales, up 219% year over year, driven by volume growth.
Amgen (AMGN - Free Report) 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 Performance
Year to date, shares of Amgen have gained nearly 1% compared with the industry‘s nil growth.
Image Source: Zacks Investment Research
More on Amgen’s Imdelltra/Imdylltra
Imdelltra, 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.
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%.
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Amgen Secures EU Nod for Imdylltra in Lung Cancer Indication
Key Takeaways
Amgen (AMGN - Free Report) 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 Performance
Year to date, shares of Amgen have gained nearly 1% compared with the industry‘s nil growth.
Image Source: Zacks Investment Research
More on Amgen’s Imdelltra/Imdylltra
Imdelltra, 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 Rank
Amgen currently carries a Zacks Rank #3 (Hold).
Amgen Inc. Price
Amgen Inc. price | Amgen Inc. Quote
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are Immunocore (IMCR - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , 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%.