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Merck (MRK) Gets CHMP Nod for Keytruda in Adjuvant Lung Cancer
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Merck & Co. (MRK - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending the approval of Keytruda as an adjuvant treatment for non-small cell lung cancer (NSCLC) in the European Union (EU).
The CHMP has recommended the approval of Keytruda for the adjuvant treatment of adults with NSCLC, who are at high risk of recurrence (stage IB-IIIA) following complete resection and platinum-based chemotherapy.
Per MRK, the positive recommendation of the CHMP is based on encouraging results from the company’s phase III KEYNOTE-091 study. Data from the study showed a statistically significant improvement in disease-free survival in the above-mentioned patient group. The study also observed clinically meaningful results in patients treated with Keytruda, who received adjuvant chemotherapy.
Although not binding in nature, the EMA will review the CHMP’s recommendation for marketing authorization to Keytruda for the expanded indication in the EU. A final decision from the regulatory body is expected in the fourth quarter of 2023.
The marketing authorization application seeks to expand Keytruda’s label as a new adjuvant treatment for the earlier stages of NSCLC.
Keytruda was approved for a similar patient population in the United States in January 2023.
Merck’s shares have lost 3.1% year to date against the industry’s 8% growth.
Image Source: Zacks Investment Research
Keytruda is already approved in the EU for several oncology indications, including melanoma, NSCLC and bladder cancer, among others.
Keytruda, an anti-PD-1 therapy, is MRK’s blockbuster oncology drug and is currently the standard of care in the treatment of first-line NSCLC. The company is also currently evaluating Keytruda in the earlier stages of lung cancer as well as identifying new combinations and co-formulations with the drug.
Keytruda is the key revenue generator for Merck. In the first half of 2023, the company recorded $12.1 billion in sales from Keytruda, up 20% year over year. Drug sales are gaining from continued strong momentum in metastatic indications and rapid uptake across recent earlier-stage launches.
Some better-ranked stocks in the overall medical sector are Dynavax Technologies (DVAX - Free Report) , Corcept Therapeutics (CORT - Free Report) and Better Therapeutics (BTTX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has remained constant at 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of DVAX have risen by 28.3%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 64.8%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
In the past 30 days, the Zacks Consensus Estimate for Better Therapeutics’ 2023 loss per share has remained constant at 98 cents. During the same period, Better Therapeutics’ 2024 loss per share has also remained constant at 80 cents. Year to date, shares of BTTX have lost 54.7%.
BTTX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 24.22%.
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Merck (MRK) Gets CHMP Nod for Keytruda in Adjuvant Lung Cancer
Merck & Co. (MRK - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending the approval of Keytruda as an adjuvant treatment for non-small cell lung cancer (NSCLC) in the European Union (EU).
The CHMP has recommended the approval of Keytruda for the adjuvant treatment of adults with NSCLC, who are at high risk of recurrence (stage IB-IIIA) following complete resection and platinum-based chemotherapy.
Per MRK, the positive recommendation of the CHMP is based on encouraging results from the company’s phase III KEYNOTE-091 study. Data from the study showed a statistically significant improvement in disease-free survival in the above-mentioned patient group. The study also observed clinically meaningful results in patients treated with Keytruda, who received adjuvant chemotherapy.
Although not binding in nature, the EMA will review the CHMP’s recommendation for marketing authorization to Keytruda for the expanded indication in the EU. A final decision from the regulatory body is expected in the fourth quarter of 2023.
The marketing authorization application seeks to expand Keytruda’s label as a new adjuvant treatment for the earlier stages of NSCLC.
Keytruda was approved for a similar patient population in the United States in January 2023.
Merck’s shares have lost 3.1% year to date against the industry’s 8% growth.
Image Source: Zacks Investment Research
Keytruda is already approved in the EU for several oncology indications, including melanoma, NSCLC and bladder cancer, among others.
Keytruda, an anti-PD-1 therapy, is MRK’s blockbuster oncology drug and is currently the standard of care in the treatment of first-line NSCLC. The company is also currently evaluating Keytruda in the earlier stages of lung cancer as well as identifying new combinations and co-formulations with the drug.
Keytruda is the key revenue generator for Merck. In the first half of 2023, the company recorded $12.1 billion in sales from Keytruda, up 20% year over year. Drug sales are gaining from continued strong momentum in metastatic indications and rapid uptake across recent earlier-stage launches.
Merck & Co., Inc. Price and Consensus
Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote
Zacks Rank and Stocks to Consider
Merck currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall medical sector are Dynavax Technologies (DVAX - Free Report) , Corcept Therapeutics (CORT - Free Report) and Better Therapeutics (BTTX - Free Report) , each carrying a Zacks Rank #2 (Buy) at present.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, the Zacks Consensus Estimate for Dynavax’s 2023 loss per share has remained constant at 24 cents. The estimate for Dynavax’s 2024 earnings per share is currently pegged at 2 cents. Year to date, shares of DVAX have risen by 28.3%.
DVAX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 25.78%.
In the past 30 days, the Zacks Consensus Estimate for Corcept’s 2023 earnings per share has remained constant at 78 cents. The estimate for Corcept’s 2024 earnings per share has also remained constant at 83 cents. Year to date, shares of CORT have climbed 64.8%.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
In the past 30 days, the Zacks Consensus Estimate for Better Therapeutics’ 2023 loss per share has remained constant at 98 cents. During the same period, Better Therapeutics’ 2024 loss per share has also remained constant at 80 cents. Year to date, shares of BTTX have lost 54.7%.
BTTX’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 24.22%.