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Merck's (MRK) Keytruda Gets FDA Nod in Sixth NSCLC Indication
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Merck (MRK - Free Report) announced that the FDA has approved its blockbuster drug Keytruda for another new indication in non-small cell lung cancer (“NSCLC”).
Following the FDA’s decision, Keytruda is now approved for treating patients with resectable NSCLC, who can get their tumors removed surgically. The drug can be used in combination with chemotherapy as a neoadjuvant treatment given before surgery and then continued as a single agent as part of an adjuvant treatment given after surgery.
The approval is based on data from the phase III KEYNOTE-671 study which showed that continued treatment with Keytruda demonstrated statistically significant improvements in event-free survival and overall survival, which are the study’s dual primary endpoints.
Following the approval, Merck’s Keytruda is now approved for six indications in NSCLC, spanning across both metastatic and earlier stages of the disease.
In a separate press release, Merck also announced that the European Commission granted label expansion to Keytruda for a fifth indication in NSCLC. Keytruda, as a single agent, is approved as an adjuvant treatment for adult patients with NSCLC who are at high risk of recurrence following complete resection and platinum-based chemotherapy. This approval marks the first immunotherapy option approved in the European Union for such patients.
Merck’s shares have lost 6.1% year to date against the industry’s 8.5% growth.
Image Source: Zacks Investment Research
Apart from NSCLC, Keytruda is approved for treatment of many cancers globally. Keytruda sales are gaining from continued strong momentum in metastatic indications and rapid uptake across recent earlier-stage launches. In the first half of 2023, the drug’s sales alone accounted for over 40% of Merck’s total revenues. Keytruda is presently approved to treat at least seven indications in earlier-stage cancers in the United States.
Keytruda is continuously growing and expanding into new indications and markets globally. Numerous recent approvals and the expected launch of many additional indications including in earlier lines of therapy can further boost sales. In the United States, MRK expects over half of Keytruda’s growth to come from indications in early-stage (neoadjuvant/adjuvant) treatment settings through 2025 and to represent roughly 25% of total global Keytruda sales by that time.
Management 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 will aid sales.
In the past 60 days, estimate for Allogene Therapeutics’ 2024 earnings per share narrowed from $2.23 to $2.21. Year to date, the stock has lost 48.5%.
ALLO’s earnings beat estimates in three of the trailing four quarters while meeting the mark on one occasion, witnessing an average earnings surprise of 3.93%. In the last reported quarter, Allogene’s earnings beat estimates by 10.17%.
In the past 60 days, estimates for Deciphera Pharmaceuticals’ 2023 loss per share have narrowed from $2.38 to $2.36. Year to date, the stock has plunged 33.9%.
DCPH’s earnings surpassed estimates in two of the last four quarters, met the mark on one occasion while missing it on another. The company witnessed an earnings surprise of 1.58% on average. In the last reported quarter, Deciphera’s earnings beat estimates by 8.06%.
In the past 60 days, estimates for Jazz Pharmaceuticals’ 2023 and 2024 earnings per share have increased from $18.49 to $18.64 and $20.31 to $20.40, respectively. Year to date, JAZZ’s stock has dipped 14.6%.
JAZZ’s earnings outpaced estimates in two of the trailing four quarters while missing the mark on the other two occasions, witnessing a negative surprise of 27.59%, on average. In the last reported quarter, Jazz Pharmaceuticals’ earnings beat estimates by 1.12%.
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Merck's (MRK) Keytruda Gets FDA Nod in Sixth NSCLC Indication
Merck (MRK - Free Report) announced that the FDA has approved its blockbuster drug Keytruda for another new indication in non-small cell lung cancer (“NSCLC”).
Following the FDA’s decision, Keytruda is now approved for treating patients with resectable NSCLC, who can get their tumors removed surgically. The drug can be used in combination with chemotherapy as a neoadjuvant treatment given before surgery and then continued as a single agent as part of an adjuvant treatment given after surgery.
The approval is based on data from the phase III KEYNOTE-671 study which showed that continued treatment with Keytruda demonstrated statistically significant improvements in event-free survival and overall survival, which are the study’s dual primary endpoints.
Following the approval, Merck’s Keytruda is now approved for six indications in NSCLC, spanning across both metastatic and earlier stages of the disease.
In a separate press release, Merck also announced that the European Commission granted label expansion to Keytruda for a fifth indication in NSCLC. Keytruda, as a single agent, is approved as an adjuvant treatment for adult patients with NSCLC who are at high risk of recurrence following complete resection and platinum-based chemotherapy. This approval marks the first immunotherapy option approved in the European Union for such patients.
Merck’s shares have lost 6.1% year to date against the industry’s 8.5% growth.
Image Source: Zacks Investment Research
Apart from NSCLC, Keytruda is approved for treatment of many cancers globally. Keytruda sales are gaining from continued strong momentum in metastatic indications and rapid uptake across recent earlier-stage launches. In the first half of 2023, the drug’s sales alone accounted for over 40% of Merck’s total revenues. Keytruda is presently approved to treat at least seven indications in earlier-stage cancers in the United States.
Keytruda is continuously growing and expanding into new indications and markets globally. Numerous recent approvals and the expected launch of many additional indications including in earlier lines of therapy can further boost sales. In the United States, MRK expects over half of Keytruda’s growth to come from indications in early-stage (neoadjuvant/adjuvant) treatment settings through 2025 and to represent roughly 25% of total global Keytruda sales by that time.
Management 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 will aid sales.
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold).
Merck & Co., Inc. Price
Merck & Co., Inc. price | Merck & Co., Inc. Quote
Some better-ranked stocks are Allogene Therapeutics (ALLO - Free Report) , Deciphera Pharmaceuticals (DCPH - Free Report) and Jazz Pharmaceuticals (JAZZ - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimate for Allogene Therapeutics’ 2024 earnings per share narrowed from $2.23 to $2.21. Year to date, the stock has lost 48.5%.
ALLO’s earnings beat estimates in three of the trailing four quarters while meeting the mark on one occasion, witnessing an average earnings surprise of 3.93%. In the last reported quarter, Allogene’s earnings beat estimates by 10.17%.
In the past 60 days, estimates for Deciphera Pharmaceuticals’ 2023 loss per share have narrowed from $2.38 to $2.36. Year to date, the stock has plunged 33.9%.
DCPH’s earnings surpassed estimates in two of the last four quarters, met the mark on one occasion while missing it on another. The company witnessed an earnings surprise of 1.58% on average. In the last reported quarter, Deciphera’s earnings beat estimates by 8.06%.
In the past 60 days, estimates for Jazz Pharmaceuticals’ 2023 and 2024 earnings per share have increased from $18.49 to $18.64 and $20.31 to $20.40, respectively. Year to date, JAZZ’s stock has dipped 14.6%.
JAZZ’s earnings outpaced estimates in two of the trailing four quarters while missing the mark on the other two occasions, witnessing a negative surprise of 27.59%, on average. In the last reported quarter, Jazz Pharmaceuticals’ earnings beat estimates by 1.12%.