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Merck Gets Positive CHMP Opinion for Keytruda in Mesothelioma
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Merck (MRK - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion, recommending the approval of its blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), for a new indication.
The CHMP has now recommended marketing approval of Keytruda in combination with chemotherapy (pemetrexed and platinum chemotherapy) for the first-line treatment of adult patients with unresectable non-epithelioid malignant pleural mesothelioma (MPM).
Pleural mesothelioma is a type of cancer that develops in the tissue that lines the lungs or pleura.
The European Commission will now review the CHMP’s opinion and a final decision from the regulatory body in Europe is expected later in the fourth quarter of 2024.
MRK's Stock Performance
Shares of Merck have plunged 11.7% so far this year against the industry’s rise of 3.3%.
Image Source: Zacks Investment Research
The above positive CHMP opinion was based on data from the pivotal phase II/III KEYNOTE-483 study. Data from the same showed that treatment with Keytruda plus chemotherapy led to a statistically significant improvement in overall survival (OS) versus chemotherapy alone.
The FDA approved Keytruda in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adult patients with unresectable advanced or metastatic MPM in September.
The approval marked the first time Keytruda was approved for MPM in the United States.
Keytruda Drives MRK's Revenues
Keytruda is the biggest product in Merck’s portfolio. The drug has played an instrumental role in driving Merck’s steady revenue growth in the past few years. Keytruda sales continue to grow year over year as well as sequentially. The drug generated sales of more than $21 billion in the first nine months of 2024.
Keytruda sales benefited from rapid uptake across earlier-stage indications in triple-negative breast cancer, renal cell carcinoma and non-small cell lung cancer (NSCLC). Continued strong momentum in metastatic indications also boosted sales growth.
This is one of the most successful cancer drugs ever and is considered a market leader for treating NSCLC. Keytruda is already approved for the treatment of many cancers globally and accounts for almost 50% of Merck’s pharmaceutical sales.
In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 53.8%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.59 to $4.71. Earnings per share estimates for 2025 have improved from $4.82 to $5.65 during the same time. Year to date, shares of ANIP have increased 2.6%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 20.27%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 30.2%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.
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Merck Gets Positive CHMP Opinion for Keytruda in Mesothelioma
Merck (MRK - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion, recommending the approval of its blockbuster anti-PD-1 therapy, Keytruda (pembrolizumab), for a new indication.
The CHMP has now recommended marketing approval of Keytruda in combination with chemotherapy (pemetrexed and platinum chemotherapy) for the first-line treatment of adult patients with unresectable non-epithelioid malignant pleural mesothelioma (MPM).
Pleural mesothelioma is a type of cancer that develops in the tissue that lines the lungs or pleura.
The European Commission will now review the CHMP’s opinion and a final decision from the regulatory body in Europe is expected later in the fourth quarter of 2024.
MRK's Stock Performance
Shares of Merck have plunged 11.7% so far this year against the industry’s rise of 3.3%.
Image Source: Zacks Investment Research
The above positive CHMP opinion was based on data from the pivotal phase II/III KEYNOTE-483 study. Data from the same showed that treatment with Keytruda plus chemotherapy led to a statistically significant improvement in overall survival (OS) versus chemotherapy alone.
The FDA approved Keytruda in combination with pemetrexed and platinum chemotherapy for the first-line treatment of adult patients with unresectable advanced or metastatic MPM in September.
The approval marked the first time Keytruda was approved for MPM in the United States.
Keytruda Drives MRK's Revenues
Keytruda is the biggest product in Merck’s portfolio. The drug has played an instrumental role in driving Merck’s steady revenue growth in the past few years. Keytruda sales continue to grow year over year as well as sequentially. The drug generated sales of more than $21 billion in the first nine months of 2024.
Keytruda sales benefited from rapid uptake across earlier-stage indications in triple-negative breast cancer, renal cell carcinoma and non-small cell lung cancer (NSCLC). Continued strong momentum in metastatic indications also boosted sales growth.
This is one of the most successful cancer drugs ever and is considered a market leader for treating NSCLC. Keytruda is already approved for the treatment of many cancers globally and accounts for almost 50% of Merck’s pharmaceutical sales.
MRK's Zacks Rank & Key Picks
Merck currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the biotech sector are Immunocore Holdings plc (IMCR - Free Report) , ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Castle Biosciences, Inc. (CSTL - Free Report) , each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time. Year to date, shares of IMCR have declined 53.8%.
IMCR’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 25.57%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.59 to $4.71. Earnings per share estimates for 2025 have improved from $4.82 to $5.65 during the same time. Year to date, shares of ANIP have increased 2.6%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 20.27%.
In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time. Year to date, shares of CSTL have surged 30.2%.
CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.