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Merck's Calderasib Gets FDA's Breakthrough Therapy Tag for NSCLC
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Key Takeaways
MRK's calderasib received its first FDA Breakthrough Therapy designation in NSCLC.
Merck's calderasib plus Keytruda targets patients with advanced KRAS G12C-mutant NSCLC.
The FDA designation was supported by positive phase I KANDLELIT-001 study data.
Merck (MRK - Free Report) announced that the FDA has granted Breakthrough Therapy designation to its investigational oral specific KRAS G12C inhibitor, calderasib (MK-1084), for treating certain patients with newly diagnosed metastatic KRAS G12C-mutant non-small cell lung cancer (NSCLC).
The regulatory body granted Breakthrough Therapy designation to calderasib in combination with Merck’s blockbuster PD-L1 inhibitor Keytruda for the first-line treatment of patients with advanced or metastatic NSCLC with a KRAS G12C mutation and expressing PD-L1. This marks the first Breakthrough Therapy designation for calderasib.
The FDA’s Breakthrough Therapy designation is intended to facilitate drug development and expedite the review of therapies for serious diseases with unmet medical needs.
MRK’s Price Performance
Year to date, shares of Merck have risen 13.6% compared with the industry’s 3.9% increase.
Image Source: Zacks Investment Research
More on MRK’s Calderasib Development Program
The FDA’s Breakthrough Therapy tag for calderasib was based on positive data from the phase I KANDLELIT-001 study.
The Breakthrough Therapy designation underscores the potential of calderasib to address a significant unmet need in patients with KRAS G12C-mutated NSCLC.
Merck is developing calderasib in collaboration with Taiho Pharmaceutical and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical.
KRAS mutations are among the most common genetic alterations in cancer, occurring frequently in NSCLC, pancreatic, urogenital and colorectal cancers.
Merck’s biggest revenue driver, Keytruda, alone accounts for around 55% of the company’s pharmaceutical sales. The drug recorded sales of $8.0 billion in the first quarter of 2026, increasing 8% year over year.
Keytruda sales are rising from continued strong momentum in metastatic indications and rapid uptake across earlier-stage indications.
Management expects Keytruda to continue to grow through label expansion into new indications and global markets, while maintaining a strong market share.
Over the past 60 days, 2026 estimates for Immunocore have moved from a loss of 88 cents per share to earnings of 6 cents, while estimates for 2027 earnings per share have risen from 24 cents to 87 cents during the same time. IMCR stock has lost 16.8% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 79.4% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
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Merck's Calderasib Gets FDA's Breakthrough Therapy Tag for NSCLC
Key Takeaways
Merck (MRK - Free Report) announced that the FDA has granted Breakthrough Therapy designation to its investigational oral specific KRAS G12C inhibitor, calderasib (MK-1084), for treating certain patients with newly diagnosed metastatic KRAS G12C-mutant non-small cell lung cancer (NSCLC).
The regulatory body granted Breakthrough Therapy designation to calderasib in combination with Merck’s blockbuster PD-L1 inhibitor Keytruda for the first-line treatment of patients with advanced or metastatic NSCLC with a KRAS G12C mutation and expressing PD-L1. This marks the first Breakthrough Therapy designation for calderasib.
The FDA’s Breakthrough Therapy designation is intended to facilitate drug development and expedite the review of therapies for serious diseases with unmet medical needs.
MRK’s Price Performance
Year to date, shares of Merck have risen 13.6% compared with the industry’s 3.9% increase.
Image Source: Zacks Investment Research
More on MRK’s Calderasib Development Program
The FDA’s Breakthrough Therapy tag for calderasib was based on positive data from the phase I KANDLELIT-001 study.
The Breakthrough Therapy designation underscores the potential of calderasib to address a significant unmet need in patients with KRAS G12C-mutated NSCLC.
Merck is developing calderasib in collaboration with Taiho Pharmaceutical and Astex Pharmaceuticals (UK), a wholly owned subsidiary of Otsuka Pharmaceutical.
KRAS mutations are among the most common genetic alterations in cancer, occurring frequently in NSCLC, pancreatic, urogenital and colorectal cancers.
Merck’s biggest revenue driver, Keytruda, alone accounts for around 55% of the company’s pharmaceutical sales. The drug recorded sales of $8.0 billion in the first quarter of 2026, increasing 8% year over year.
Keytruda sales are rising from continued strong momentum in metastatic indications and rapid uptake across earlier-stage indications.
Management expects Keytruda to continue to grow through label expansion into new indications and global markets, while maintaining a strong market share.
MRK’s Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, 2026 estimates for Immunocore have moved from a loss of 88 cents per share to earnings of 6 cents, while estimates for 2027 earnings per share have risen from 24 cents to 87 cents during the same time. IMCR stock has lost 16.8% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 79.4% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.