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GSK's Jemperli Gets EU Nod for Endometrial Cancer Expanded Use
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GSK plc (GSK - Free Report) announced that the European Commission (EC) has granted marketing authorization to its cancer drug, Jemperli (dostarlimab), for expanded use in primary advanced or recurrent endometrial cancer.
The EC has now approved Jemperli in combination with carboplatin and paclitaxel as a frontline treatment for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced/recurrent endometrial cancer in adult patients who are candidates for systemic therapy.
Until now, Jemperli was approved on a conditional basis in the EU as a monotherapy to treat adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen. With the latest approval, Jemperli becomes eligible for an expanded patient population in Europe, including in earlier line-setting.
The latest EC nod for Jemperli in the frontline setting also converts this conditional approval to a full approval.
Shares of GSK have rallied 3.5% year to date against the industry’s decline of 20.4%.
Image Source: Zacks Investment Research
The EC’s nod for Jemperli in frontline use was based on pivotal data from Part 1 of the RUBY phase III study. Data from the study showed that treatment with Jemperli in combination with carboplatin plus paclitaxel resulted in a 72% reduction in the risk of disease progression or death versus chemotherapy alone.
The FDA approved Jemperli in combination with carboplatin plus paclitaxel as a frontline treatment for dMMR/MSI-H primary advanced/recurrent endometrial cancer in July 2023.
Jemperli is also approved for second-line endometrial cancer and dMMR recurrent or advanced solid tumors in the United States.
Jemperli is one of the recently approved drugs in GSK’s portfolio that has been seeing strong uptake owing to an increase in new patient starts in the United States. The drug generated sales worth £81 million in the first nine months of 2023.
Several label expansion studies are currently ongoing on Jemperli in endometrial cancer.
In a separate press release, GSK announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review the regulatory application seeking label expansion of its respiratory syncytial virus (RSV) vaccine, Arexvy, for the prevention of RSV disease in adults aged 50-59 who are at a higher risk.
Arexvy is approved in Japan for the prevention of RSV disease in adults aged 60 years and above.
In the past 60 days, estimates for Journey Medical’s 2023 loss per share have narrowed from $1.28 to 16 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 41 cents to 35 cents. Year to date, shares of DERM have surged 214.6%.
Earnings of Journey Medical beat estimates in one of the last four quarters while missing the same on the remaining three occasions. DERM delivered a four-quarter earnings surprise of 118.25%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. Year to date, shares of TRDA have decreased 4%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 64 cents. Year to date, shares of PBYI have lost 10.2%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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GSK's Jemperli Gets EU Nod for Endometrial Cancer Expanded Use
GSK plc (GSK - Free Report) announced that the European Commission (EC) has granted marketing authorization to its cancer drug, Jemperli (dostarlimab), for expanded use in primary advanced or recurrent endometrial cancer.
The EC has now approved Jemperli in combination with carboplatin and paclitaxel as a frontline treatment for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced/recurrent endometrial cancer in adult patients who are candidates for systemic therapy.
Until now, Jemperli was approved on a conditional basis in the EU as a monotherapy to treat adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen. With the latest approval, Jemperli becomes eligible for an expanded patient population in Europe, including in earlier line-setting.
The latest EC nod for Jemperli in the frontline setting also converts this conditional approval to a full approval.
Shares of GSK have rallied 3.5% year to date against the industry’s decline of 20.4%.
The EC’s nod for Jemperli in frontline use was based on pivotal data from Part 1 of the RUBY phase III study. Data from the study showed that treatment with Jemperli in combination with carboplatin plus paclitaxel resulted in a 72% reduction in the risk of disease progression or death versus chemotherapy alone.
The FDA approved Jemperli in combination with carboplatin plus paclitaxel as a frontline treatment for dMMR/MSI-H primary advanced/recurrent endometrial cancer in July 2023.
Jemperli is also approved for second-line endometrial cancer and dMMR recurrent or advanced solid tumors in the United States.
Jemperli is one of the recently approved drugs in GSK’s portfolio that has been seeing strong uptake owing to an increase in new patient starts in the United States. The drug generated sales worth £81 million in the first nine months of 2023.
Several label expansion studies are currently ongoing on Jemperli in endometrial cancer.
In a separate press release, GSK announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has accepted for review the regulatory application seeking label expansion of its respiratory syncytial virus (RSV) vaccine, Arexvy, for the prevention of RSV disease in adults aged 50-59 who are at a higher risk.
Arexvy is approved in Japan for the prevention of RSV disease in adults aged 60 years and above.
Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Journey Medical Corporation (DERM - Free Report) , Entrada Therapeutics, Inc. (TRDA - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , each sporting a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Journey Medical’s 2023 loss per share have narrowed from $1.28 to 16 cents. Meanwhile, loss per share estimates for 2024 have narrowed from 41 cents to 35 cents. Year to date, shares of DERM have surged 214.6%.
Earnings of Journey Medical beat estimates in one of the last four quarters while missing the same on the remaining three occasions. DERM delivered a four-quarter earnings surprise of 118.25%, on average.
In the past 60 days, estimates for Entrada Therapeutics’ 2023 loss per share have narrowed from $2.07 to 9 cents. Meanwhile, loss per share estimates for 2024 have narrowed from $2.35 to $2.04. Year to date, shares of TRDA have decreased 4%.
Earnings of Entrada Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. TRDA delivered a four-quarter average earnings surprise of 70.68%.
In the past 60 days, estimates for Puma Biotechnology’s 2023 earnings per share have improved from 67 cents to 72 cents. During the same period, earnings per share estimates for 2024 have moved up from 55 cents to 64 cents. Year to date, shares of PBYI have lost 10.2%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.