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 fall
19 Analyst Rating
11 Buy
7 Hold
1 Sell
Moderate Buy
Current: 366.580
Low
272.00
Averages
345.87
High
425.00
Current: 366.580
Low
272.00
Averages
345.87
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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- Long-Term Control Potential: UPLIZNA demonstrates the potential for long-term disease control through a semi-annual maintenance dose following two initial loading doses, which may reduce patients' reliance on long-term steroids, thereby improving their quality of life.
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- New Therapy Approval: Amgen's UPLIZNA (inebilizumab) has received approval from the European Commission as an add-on treatment for adults with anti-AChR+ and anti-MuSK+ generalized myasthenia gravis (gMG), marking a significant advancement in this therapeutic area.
- Significant Treatment Efficacy: UPLIZNA demonstrates durable disease control through a twice-yearly maintenance dosing regimen following two initial loading doses, which is expected to reduce patients' long-term reliance on steroids.
- Clinical Trial Support: The approval is backed by data from the MINT trial, the first Phase 3 biologic study to include both AChR+ and MuSK+ patients, showing that 87.4% of UPLIZNA patients reduced their steroid dose to 5 mg or less by Week 26.
- Huge Market Potential: The approval of UPLIZNA not only provides a new treatment option for gMG patients but also has the potential to expand into other autoimmune diseases in the future, further solidifying Amgen's leadership in the biopharmaceutical sector.
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- New Treatment Option: UPLIZNA (inebilizumab) has been approved by the European Commission as an adjunct treatment for adults with anti-AChR+ and MuSK+ myasthenia gravis (MGg), offering a biannual maintenance dosage that may reduce long-term steroid use.
- Clinical Trial Support: The approval is backed by data from the MINT study involving 238 MGg patients, where 87.4% of UPLIZNA patients reduced their steroid dosage to 5 mg or less by week 26, demonstrating significant efficacy.
- Market Potential: With an estimated 56,000 to 123,000 individuals affected by MGg in Europe, the approval of UPLIZNA provides a new treatment option for this rare disease, potentially improving patients' quality of life significantly.
- Long-term Efficacy Expectations: By targeting CD19-positive B cells, UPLIZNA offers durable disease control, which may transform the treatment landscape for MGg and lessen patients' reliance on steroids, enhancing overall treatment outcomes.
See More
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- New Therapy Approval: Amgen announced that UPLIZNA (inebilizumab) has been approved by the European Commission as a new treatment option for adults with gMG who are anti-AChR+ and anti-MuSK+, marking a significant advancement in addressing this rare autoimmune disease.
- Long-Term Control Potential: UPLIZNA demonstrates the potential for long-term disease control through a semi-annual maintenance dose following two initial loading doses, which may reduce patients' reliance on long-term steroids, thereby improving their quality of life.
- Clinical Trial Support: The approval is backed by data from the MINT trial, the largest Phase 3 study for gMG, where 87.4% of UPLIZNA patients successfully reduced their steroid dosage to 5mg or less daily by week 26, showcasing its efficacy.
- Broad Market Prospects: The approval of UPLIZNA not only provides a new treatment option for gMG patients but also positions it to potentially play a significant role in the future market, especially regarding its potential against other autoimmune diseases, further solidifying Amgen's leadership in the biopharmaceutical sector.
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