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: 348.430
Low
280.00
Averages
363.10
High
425.00
Current: 348.430
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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- Revenue Surge: As of now, Anthropic's annual recurring revenue (ARR) has skyrocketed to $14 billion, a remarkable increase from $100 million in early 2024 and $1 billion in 2025, reflecting the success of its business model and strong market demand.
- Funding and Valuation: In February, Anthropic closed a $30 billion Series G funding round, valuing the company at $380 billion, surpassing several well-known firms like Coca-Cola and AMD, showcasing strong investor confidence in its future potential.
- Diverse Investment Channels: While Anthropic is a private company, making direct stock purchases challenging for ordinary investors, the KraneShares Artificial Intelligence and Technology ETF (AGIX) offers a way to gain indirect exposure to Anthropic, with AGIX outperforming the S&P 500.
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- Significant User Growth: The Claude large language model boasts 19 million monthly active users on its desktop application compared to 7 million on mobile, indicating rapid adoption among high-value enterprise clients, which has propelled the company's annual recurring revenue (ARR) to an impressive $14 billion.
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- Revenue Surge: As of now, Anthropic's annual recurring revenue (ARR) has skyrocketed to $14 billion, a remarkable increase from $100 million in early 2024 and $1 billion in 2025, reflecting the success of its business model and strong market demand.
- Funding and Valuation: In February, Anthropic closed a $30 billion Series G funding round, valuing the company at $380 billion, surpassing several well-known firms like Coca-Cola and AMD, showcasing strong investor confidence in its future potential.
- Diverse Investment Channels: While Anthropic is a private company, making direct stock purchases challenging for ordinary investors, the KraneShares Artificial Intelligence and Technology ETF (AGIX) offers a way to gain indirect exposure to Anthropic, with AGIX outperforming the S&P 500.
See More
Anthropic's Rise in the AI Landscape
- Massive Fundraising: Anthropic closed a $30 billion Series G funding round in early February, valuing the company at $380 billion, surpassing well-known firms like Amgen and Coca-Cola, which highlights its strong market appeal and investor confidence in the AI sector.
- Significant User Growth: The Claude large language model boasts 19 million monthly active users on its desktop application compared to 7 million on mobile, indicating rapid adoption among high-value enterprise clients, which has propelled the company's annual recurring revenue (ARR) to an impressive $14 billion.
- Diverse Investor Base: Leading tech companies such as Nvidia, Microsoft, and Amazon are among Anthropic's investors, while the KraneShares Artificial Intelligence and Technology ETF (NASDAQ: AGIX) offers ordinary investors a route to gain indirect exposure to Anthropic, further enhancing its market influence.
- Strong ETF Performance: Since the launch of AGIX by KraneShares, the fund has significantly outperformed the S&P 500, and although its nearly 1% expense ratio is relatively high, its focus on the AI sector makes it an attractive option for investors seeking long-term growth opportunities.
See More
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- High-Dose Approval: The FDA has approved Novo Nordisk's high-dose Wegovy at 7.2 mg, set to launch in April, aiming to regain market share against Eli Lilly's Zepbound.
- Clinical Trial Results: In a phase three trial, high-dose Wegovy led to an average weight loss of 20.7% over 72 weeks, significantly outperforming the standard dose's 15%, enhancing its competitive edge.
- Increased Patient Options: The new dosage provides more options for patients who struggle to meet weight loss targets, as noted by Novo Nordisk's U.S. medical head, potentially improving treatment satisfaction and outcomes.
- Policy Support: This approval marks the first GLP-1 treatment under the FDA's new national priority voucher plan, aimed at expediting drug review times, highlighting Novo Nordisk's strategic positioning in the industry.
See More
Strong Dividend ETF Recommendation
- Dividend Yield: The Schwab U.S. Dividend Equity ETF (SCHD) recently offers a dividend yield of 3.3%, providing a stable income source amidst current economic uncertainties, appealing to defensive investors.
- Historical Performance: Since its inception in 2011, the ETF has achieved an average annual return of 13.30%, with a 15.67% return over the past year, demonstrating strong performance in volatile markets and boosting investor confidence.
- Portfolio Strength: SCHD holds approximately 100 stocks, including blue-chip companies like Lockheed Martin, Coca-Cola, and PepsiCo, ensuring investment diversity and stability, thereby providing long-term capital appreciation potential for investors.
- Long-Term Investment Returns: Investing $1,200 annually, with an assumed annual return of 10%, could yield around $68,730 after 20 years, highlighting the ETF's appeal as a long-term investment vehicle.
See More
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- Annual Returns: The Schwab U.S. Dividend Equity ETF has achieved an average annual gain of 13.37% over the past decade, demonstrating robust performance in a volatile market, appealing to investors seeking stable returns.
- Dividend Yield: With a recent dividend yield of 3.3%, this ETF not only provides a steady cash flow but also offers the potential for capital appreciation, making it suitable for defensive investing in uncertain economic conditions.
- Investment Returns: Investing $1,200 annually with an assumed annual return of 10% could yield approximately $68,730 in 20 years, highlighting the power of compounding and encouraging a focus on long-term holding strategies.
- Portfolio Composition: The ETF holds around 100 stocks, primarily blue-chip companies, with top holdings like Lockheed Martin and Coca-Cola, further enhancing the stability and income potential of its investment portfolio.
See More
Amgen and GSK Join TrumpRx Drug Sales Platform
- Expansion of Drug Sales: Amgen (AMGN) and GSK (GSK) are adding their medications to the TrumpRx platform, bringing the total to 54 prescription drugs available, marking a significant step in the government's push for drug affordability.
- Significant Price Discounts: Amgen plans to offer Amjevita at $299 on TrumpRx, a staggering 80% reduction from its current U.S. list price of $1,484; additionally, Aimovig and Repatha will also see around 60% discounts, greatly enhancing consumer purchasing power.
- GSK Drug Discounts: GSK's Incruse for chronic obstructive pulmonary disease will be priced at $159 on TrumpRx, reflecting a 55% discount; furthermore, other medications like Arnuity, Relenza, and Anoro will have discounts ranging from 10% to 51%, boosting market competitiveness.
- Far-reaching Policy Impact: The inclusion of Amgen and GSK not only diversifies the drug offerings on TrumpRx but also underscores the Trump administration's firm stance on drug pricing policies, aiming to enhance drug accessibility through Most Favored Nation pricing.
See More
