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Merck (MRK) Gets EU Nod for Expanded Use in Gastric Cancer
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Merck (MRK - Free Report) announced that the European Commission (EC) approved its blockbuster drug Keytruda for two new indications in gastrointestinal cancers.
The EC approved Keytruda, combined with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The EC also approved Keytruda, combined with gemcitabine and cisplatin, for the first-line treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC).
These approvals were expected as the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Keytruda’s approval in the indications in the past two months.
The EC and CHMP decisions on the GEJ and BTC indications are based on data from the phase III KEYNOTE-859 and KEYNOTE-966 studies, respectively. Data from respective studies show that patients treated with the Keytruda combination demonstrated a statistically significant improvement in overall survival compared with patients who only received chemotherapy.
Following these approvals, a combination therapy involving Keytruda will be available to patients with HER2-negative and HER2-positive advanced gastric or GEJ adenocarcinoma. The approvals mark the sixth and seventh indications for Keytruda in gastrointestinal cancers in the European Union. Overall, Keytruda is approved for 26 indications in the region.
Last month, Merck announced that the FDA approved Keytruda in the indications mentioned above.
Merck’s shares have lost 4.4% year to date against the industry’s 3.9% growth.
Image Source: Zacks Investment Research
An anti-PD-1 therapy, Keytruda is Merck’s blockbuster oncology drug approved for several types of cancer, contributing around 46% to total revenues in the first nine months of 2023. Merck continue to boost Keytruda across new indications and markets globally. Sales of the drug are gaining from continued strong momentum in metastatic indications and rapid uptake across recent earlier-stage launches.
Merck is evaluating Keytruda across many indications that are progressing well. Keytruda is being studied for more than 30 types of cancer indications in more than 1600 studies, including combination studies. If approved, label expansions for new cancer indications can further boost sales.
Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Galapagos (GLPG - Free Report) , Novo Nordisk (NVO - Free Report) and Ocuphire Pharma (OCUP - Free Report) . While Galapagos and Ocuphire Pharma sport a Zacks Rank #1 (Strong Buy) at present, Novo Nordisk carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, Galapagos’ estimates for 2023 have improved from a loss of $1.96 per share to 79 cents. During the same period, loss estimates per share for 2024 have narrowed from $3.22 to $1.68. Galapagos’ shares have lost 11.5% in the year-to-date period.
Galapagos’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 91.97%. In the last reported quarter, Galapagos’ earnings beat estimates by 140.78%.
In the past 60 days, Ocuphire’s estimates for 2023 have improved from a loss of 60 cents per share to 42 cents. During the same period, loss estimates per share for 2024 have narrowed from 85 cents to 57 cents. Ocuphire’s shares have lost 26.1% in the year-to-date period.
Ocuphire’s earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an earnings surprise of 59.28%. In the last reported quarter, Ocuphire’s earnings beat estimates by 178.13%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.51 to $2.61. During the same period, the earnings estimates for 2024 have risen from $2.95 to $3.10. Shares of NVO have surged 46.3% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.
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Merck (MRK) Gets EU Nod for Expanded Use in Gastric Cancer
Merck (MRK - Free Report) announced that the European Commission (EC) approved its blockbuster drug Keytruda for two new indications in gastrointestinal cancers.
The EC approved Keytruda, combined with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The EC also approved Keytruda, combined with gemcitabine and cisplatin, for the first-line treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma (BTC).
These approvals were expected as the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending Keytruda’s approval in the indications in the past two months.
The EC and CHMP decisions on the GEJ and BTC indications are based on data from the phase III KEYNOTE-859 and KEYNOTE-966 studies, respectively. Data from respective studies show that patients treated with the Keytruda combination demonstrated a statistically significant improvement in overall survival compared with patients who only received chemotherapy.
Following these approvals, a combination therapy involving Keytruda will be available to patients with HER2-negative and HER2-positive advanced gastric or GEJ adenocarcinoma. The approvals mark the sixth and seventh indications for Keytruda in gastrointestinal cancers in the European Union. Overall, Keytruda is approved for 26 indications in the region.
Last month, Merck announced that the FDA approved Keytruda in the indications mentioned above.
Merck’s shares have lost 4.4% year to date against the industry’s 3.9% growth.
Image Source: Zacks Investment Research
An anti-PD-1 therapy, Keytruda is Merck’s blockbuster oncology drug approved for several types of cancer, contributing around 46% to total revenues in the first nine months of 2023. Merck continue to boost Keytruda across new indications and markets globally. Sales of the drug are gaining from continued strong momentum in metastatic indications and rapid uptake across recent earlier-stage launches.
Merck is evaluating Keytruda across many indications that are progressing well. Keytruda is being studied for more than 30 types of cancer indications in more than 1600 studies, including combination studies. If approved, label expansions for new cancer indications can further boost sales.
Merck & Co., Inc. Price
Merck & Co., Inc. price | Merck & Co., Inc. Quote
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Galapagos (GLPG - Free Report) , Novo Nordisk (NVO - Free Report) and Ocuphire Pharma (OCUP - Free Report) . While Galapagos and Ocuphire Pharma sport a Zacks Rank #1 (Strong Buy) at present, Novo Nordisk carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, Galapagos’ estimates for 2023 have improved from a loss of $1.96 per share to 79 cents. During the same period, loss estimates per share for 2024 have narrowed from $3.22 to $1.68. Galapagos’ shares have lost 11.5% in the year-to-date period.
Galapagos’ earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an average surprise of 91.97%. In the last reported quarter, Galapagos’ earnings beat estimates by 140.78%.
In the past 60 days, Ocuphire’s estimates for 2023 have improved from a loss of 60 cents per share to 42 cents. During the same period, loss estimates per share for 2024 have narrowed from 85 cents to 57 cents. Ocuphire’s shares have lost 26.1% in the year-to-date period.
Ocuphire’s earnings beat estimates in three of the last four quarters while missing the estimates on one occasion. On average, the company witnessed an earnings surprise of 59.28%. In the last reported quarter, Ocuphire’s earnings beat estimates by 178.13%.
In the past 60 days, estimates for Novo Nordisk’s 2023 earnings per share have increased from $2.51 to $2.61. During the same period, the earnings estimates for 2024 have risen from $2.95 to $3.10. Shares of NVO have surged 46.3% in the year-to-date period.
Novo Nordisk’s earnings beat estimates in two of the last four quarters while meeting the mark on one occasion and missing the estimates on another. On average, the company witnessed an average surprise of 0.58%. In the last reported quarter, Novo Nordisk’s earnings beat estimates by 5.80%.