FDA Approves Bayer's New Lung Cancer Treatment — Initial Results Appear Encouraging
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 20 2025
0mins
Should l Buy AMGN?
Source: Benzinga
FDA Approval for Hyrnuo: The FDA granted accelerated approval to Bayer AG's Hyrnuo (sevabertinib) for adults with advanced non-squamous non-small cell lung cancer (NSCLC) with HER2 mutations, following prior systemic therapy.
Companion Diagnostic Device: The Oncomine Dx Target Test was approved as a companion diagnostic to detect HER2 TKD activating mutations in NSCLC patients eligible for sevabertinib treatment.
Efficacy of Hyrnuo: In clinical studies, Hyrnuo showed a 71% objective response rate in patients with HER2 mutations who had prior systemic therapy, with a median duration of response of 9.2 months.
Full Approval for Imdelltra: The FDA also fully approved Amgen's Imdelltra (tarlatamab-dlle) for extensive stage small cell lung cancer, demonstrating a 40% reduction in death risk and extending median overall survival by over five months compared to standard chemotherapy.
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Analyst Views on AMGN
Wall Street analysts forecast AMGN stock price to rise
24 Analyst Rating
14 Buy
9 Hold
1 Sell
Moderate Buy
Current: 350.950
Low
280.00
Averages
363.10
High
425.00
Current: 350.950
Low
280.00
Averages
363.10
High
425.00
About AMGN
Amgen Inc. is a biotechnology company. It discovers, develops, manufactures and delivers medicines for the toughest diseases. It focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve people’s lives. It operates in the human therapeutics segment. Its marketed products portfolio includes EPOGEN (epoetin alfa); Aranesp (darbepoetin alfa); Parsabiv (etelcalcetide); Neulasta (pegfilgrastim); KANJINTI (trastuzumab-anns); Otezla; BLINCYTO (blinatumomab); ACTIMMUNE (interferon gamma-1b); Neulasta (pegfilgrastim); Sensipar/Mimpara (cinacalcet); Prolia (denosumab); ENBREL; QUINSAIR (levofloxacin); Repatha (evolocumab) and others. It markets ENBREL, a tumor necrosis factor blocker, in the United States and Canada. It markets Otezla, a small molecule that inhibits phosphodiesterase 4, in many countries around the world. It markets Repatha, a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in many countries around the world.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Viridian Drug Performance: Viridian's Elegrobar reduced eye bulging by approximately 54% and 63% over four and eight weeks, respectively, although its efficacy is lower than Amgen's; however, its simpler subcutaneous injection method may provide a competitive edge in the market.
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