Merck's calderasib Receives FDA Breakthrough Therapy Designation
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 18 hours ago
0mins
Merck announced that calderasib, an investigational oral specific KRAS G12C inhibitor, in combination with KEYTRUDA, Merck's anti-PD-1 therapy, has been granted Breakthrough Therapy designation by the U.S. FDA for the first-line treatment of patients with advanced or metastatic non-small cell lung cancer with KRAS G12C-mutation and expressing PD-L1. This is the first Breakthrough Therapy designation for calderasib and was supported by positive data from the Phase 1 KANDLELIT-001 trial.
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Analyst Views on MRK
Wall Street analysts forecast MRK stock price to fall
16 Analyst Rating
11 Buy
5 Hold
0 Sell
Moderate Buy
Current: 119.890
Low
95.00
Averages
119.53
High
139.00
Current: 119.890
Low
95.00
Averages
119.53
High
139.00
About MRK
Merck & Co., Inc. is a global health care company that delivers health solutions through its prescription medicines, including biologic therapies, vaccines and animal health products. Its Pharmaceutical segment includes human health pharmaceutical and vaccine products. The Company sells its human health pharmaceutical products primarily to drug wholesalers and retailers, hospitals, government agencies and managed health care providers. It sells these human health vaccines primarily to physicians, wholesalers, distributors and government entities. Its Animal Health segment discovers, develops, manufactures and markets a range of veterinary pharmaceutical and vaccine products, as well as health management solutions and services, for the prevention, treatment and control of disease in all livestock and companion animal species. Its products include KEYTRUDA (pembrolizumab) injection, for intravenous use; WELIREG (belzutifan) tablets, for oral use; Ohtuvayre (ensifentrine) and others.
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.
Calderasib Receives Breakthrough Therapy Designation
- Breakthrough Therapy Designation: Calderasib (MK-1084), an oral KRASG12C inhibitor, has received Breakthrough Therapy designation from the FDA for the treatment of advanced non-small cell lung cancer (NSCLC), particularly for patients with PD-L1 expression ≥1%, highlighting its potential in addressing unmet medical needs.
- Clinical Trial Support: This designation is supported by positive data from the KANDLELIT-001 trial, demonstrating significant improvements in treatment outcomes when combined with KEYTRUDA, thus fulfilling urgent medical needs for patients with KRASG12C mutations.
- Clinical Development Program: The KANDLELIT clinical development program for calderasib includes five Phase 3 trials across various tumor types, which is expected to accelerate its application in different cancers and further solidify Merck's leadership in oncology treatment.
- Broad Market Potential: The KRASG12C mutation occurs in approximately 14% of NSCLC patients, and targeted therapies for this prevalent mutation are poised to create new market opportunities for Merck, driving growth in the global oncology drug market.
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- Breakthrough Therapy Designation: Calderasib (MK-1084), an oral KRASG12C inhibitor, has received Breakthrough Therapy designation from the FDA for the treatment of advanced non-small cell lung cancer (NSCLC), particularly for patients with PD-L1 expression ≥1%, highlighting its potential in addressing unmet medical needs.
- Clinical Trial Support: This designation is supported by positive data from the KANDLELIT-001 trial, demonstrating significant improvements in treatment outcomes when combined with KEYTRUDA, thus fulfilling urgent medical needs for patients with KRASG12C mutations.
- Clinical Development Program: The KANDLELIT clinical development program for calderasib includes five Phase 3 trials across various tumor types, which is expected to accelerate its application in different cancers and further solidify Merck's leadership in oncology treatment.
- Broad Market Potential: The KRASG12C mutation occurs in approximately 14% of NSCLC patients, and targeted therapies for this prevalent mutation are poised to create new market opportunities for Merck, driving growth in the global oncology drug market.
See More
Dell Technologies Poised to Dominate Computer Market
- Dell's Impressive Earnings: Dell Technologies' latest earnings report is described as a 'blowout,' indicating strong market demand that could signify its dominance in the computer space, further fueling enthusiasm around data center trades.
- Nvidia's Challenges: While tech stocks have performed well, Nvidia has emerged as a notable laggard, with expectations that CEO Jensen Huang's upcoming keynote at Computex in Taiwan could introduce new products and potentially shift this trend.
- Market Dynamics to Watch: Next week, Merck will review its cancer portfolio, while Palo Alto Networks and Ulta are set to report earnings; Cramer anticipates that these companies may be influenced by AI-driven market changes, particularly in cybersecurity.
- Employment Data Impact: The Labor Department's jobs report on Friday will shape expectations for interest rate cuts, with Cramer noting that the data needs to be weak enough to justify a rate cut from the Federal Reserve, which could influence investor decisions.
See More
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- Dell's Blockbuster Earnings: Dell Technologies' recent earnings report is described as a 'blowout,' reigniting enthusiasm for AI and data center stocks, and potentially marking a pivotal moment for its dominance in the computer space.
- Nvidia's Lagging Performance: Despite the strong performance of tech stocks, Nvidia has emerged as a laggard, with Cramer suggesting that next week's Computex keynote by CEO Jensen Huang could provide crucial updates that may shift this trend.
- Upcoming Earnings Reports: A series of earnings reports from companies like Palo Alto and Broadcom next week are expected to offer significant insights for investors, particularly regarding the rising AI-driven cybersecurity threats that could impact results.
- Lululemon's Reset Quarter: Cramer cautions that Lululemon may face a challenging 'reset quarter,' advising investors to be cautious ahead of the earnings report to mitigate potential losses.
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- Reduction in Animal Testing: The FDA has proposed to reduce animal studies in cancer drug development by recommending only rodent trials or replacing three-month non-human primate studies with evidence-based risk assessments, thereby expediting the drug development process.
- Shortening R&D Timelines: The agency noted that current R&D timelines extend 10 to 12 years, and this proposal aims to shorten that duration, enhancing the efficiency of bringing new therapies to market to meet urgent healthcare demands.
- Public Comment Period: The draft guidance is open for public comments until July 30, as the FDA seeks to refine this policy through stakeholder feedback, further promoting regulatory pathways for drug development.
- Commitment to Reduce Animal Testing: FDA's oncology head, Angelo de Claro, emphasized that this guidance not only supports the commitment to expedite regulatory pathways but also fulfills the agency's promise to reduce the use of animal testing in drug development, reflecting a dual focus on ethics and science.
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- Portfolio Diversification: VYM's largest sector is financials (20.2%), followed by technology (14.8%) and industrials (14.2%), allowing investors to diversify risks across different economic sectors and reduce reliance on a single industry.
- Schwab Dividend ETF Performance: The Schwab U.S. Dividend Equity ETF (SCHD) holds 103 stocks with a dividend yield of 3.29%, and although its long-term performance has lagged behind VYM and the S&P 500, it has shown strong performance in 2026 with a year-to-date total return of about 17.8%.
- Considerations for ETF Selection: When choosing between VYM and SCHD, investors should consider diversification and safety, as VYM offers greater diversification with 608 stocks, while SCHD is more attractive in terms of dividend yield, making it suitable for those seeking stable income.
See More
Vanguard High Dividend ETF Underperforms S&P 500
- Long-Term Performance: The Vanguard High Dividend Yield ETF has an annualized return of 11.9% over the past five years, and while it has shown strong performance in 2026, it still lags behind the S&P 500, indicating relative weakness in market volatility.
- Expense Ratio Advantage: With an ultra-low expense ratio of 0.04% for the Vanguard ETF and 0.06% for the Schwab U.S. Dividend Equity ETF, both funds are competitively positioned for cost-conscious investors seeking steady income.
- Portfolio Diversification: The Vanguard ETF holds 608 stocks across various sectors, particularly in finance and technology, providing better diversification compared to the Schwab ETF's 103 stocks, thereby reducing single-sector risk.
- Dividend Yield Comparison: The Vanguard ETF offers a dividend yield of 2.24%, while the Schwab ETF provides a higher yield of 3.29%; despite the Schwab ETF's attractiveness in yield, the Vanguard's diversified portfolio may better withstand market fluctuations.
See More
