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GSK's Filing for Expanded Use of Jemperli Gets EMA Acceptance
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GSK plc (GSK - Free Report) announced that the European Medicines Agency (“EMA”) has accepted its application seeking approval for the expanded use of its cancer drug Jemperli (dostarlimab). The application is seeking approval for Jemperli plus chemotherapy to treat all adult patients with primary advanced or recurrent endometrial cancer.
Pending review by the EMA’s Committee for Medicinal Products for Human Use, a decision from the European Commission is expected in the first half of 2025.
Jemperli is currently approved for use in combination with standard-of-care chemotherapy combination, carboplatin and paclitaxel for treating adult patients with primary advanced or recurrent endometrial cancer that is either mismatch repair deficient or microsatellite instability-high in Europe.
The above application seeks to expand the drug’s use to include all patients with primary advanced or recurrent endometrial cancer, including patients with mismatch repair proficient /microsatellite stable tumors. The latest filing was based on data from part 1 of the RUBY phase III study. The study met its primary endpoints of progression-free survival and overall survival.
Data from the study showed that treatment with Jemperli plus chemotherapy led to a statistically significant and clinically meaningful benefit in the overall population of patients as compared with chemotherapy alone.
Shares of GSK have rallied 9.2% so far this year against the industry’s decline of 5.8%.
Image Source: Zacks Investment Research
A similar regulatory filing seeking expanded use of Jemperli plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer is currently under review in the United States.
A decision from the FDA is expected on Aug 23, 2024.
Jemperli is a key drug that aids GSK’s oncology sales. The drug generated sales worth £80 million in the first quarter of 2024. Jemperli sales were driven by new patient starts in the United States.
In a separate press release, GSK announced that Japan’s Ministry of Health, Labour and Welfare has approved Omjjara (momelotinib) for the treatment of myelofibrosis, based on data from the pivotal phase III MOMENTUM and SIMPLIFY-1 studies.
Omjjara is approved under the trade name of Ojjaara in the United States. Omjjara is also approved in Europe and the United Kingdom.
In the past 60 days, estimates for Acrivon Therapeutics’ 2024 loss per share have narrowed from $3.30 to $2.47. Loss per share estimates for 2025 have narrowed from $3.13 to $2.55. Year to date, shares of ACRV have surged 34.3%.
ACRV’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining one occasion, the average surprise being 3.56%.
In the past 60 days, estimates for Aligos Therapeutics’ 2024 loss per share have narrowed from 84 cents to 73 cents, while loss per share estimates for 2025 have narrowed from 82 cents to 71 cents. Year to date, shares of ALGS have declined 32%.
Aligos Therapeutics’ earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, the average surprise being 7.83%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $3.19 to $2.93. Loss per share estimates for 2025 have narrowed from $2.40 to $2.05. Year to date, shares of RAPT have plunged 87.4%.
RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.
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GSK's Filing for Expanded Use of Jemperli Gets EMA Acceptance
GSK plc (GSK - Free Report) announced that the European Medicines Agency (“EMA”) has accepted its application seeking approval for the expanded use of its cancer drug Jemperli (dostarlimab). The application is seeking approval for Jemperli plus chemotherapy to treat all adult patients with primary advanced or recurrent endometrial cancer.
Pending review by the EMA’s Committee for Medicinal Products for Human Use, a decision from the European Commission is expected in the first half of 2025.
Jemperli is currently approved for use in combination with standard-of-care chemotherapy combination, carboplatin and paclitaxel for treating adult patients with primary advanced or recurrent endometrial cancer that is either mismatch repair deficient or microsatellite instability-high in Europe.
The above application seeks to expand the drug’s use to include all patients with primary advanced or recurrent endometrial cancer, including patients with mismatch repair proficient /microsatellite stable tumors. The latest filing was based on data from part 1 of the RUBY phase III study. The study met its primary endpoints of progression-free survival and overall survival.
Data from the study showed that treatment with Jemperli plus chemotherapy led to a statistically significant and clinically meaningful benefit in the overall population of patients as compared with chemotherapy alone.
Shares of GSK have rallied 9.2% so far this year against the industry’s decline of 5.8%.
Image Source: Zacks Investment Research
A similar regulatory filing seeking expanded use of Jemperli plus chemotherapy to include all adult patients with primary advanced or recurrent endometrial cancer is currently under review in the United States.
A decision from the FDA is expected on Aug 23, 2024.
Jemperli is a key drug that aids GSK’s oncology sales. The drug generated sales worth £80 million in the first quarter of 2024. Jemperli sales were driven by new patient starts in the United States.
In a separate press release, GSK announced that Japan’s Ministry of Health, Labour and Welfare has approved Omjjara (momelotinib) for the treatment of myelofibrosis, based on data from the pivotal phase III MOMENTUM and SIMPLIFY-1 studies.
Omjjara is approved under the trade name of Ojjaara in the United States. Omjjara is also approved in Europe and the United Kingdom.
Zacks Rank & Stocks to Consider
GSK currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Acrivon Therapeutics, Inc. (ACRV - Free Report) , Aligos Therapeutics, Inc. (ALGS - Free Report) and RAPT Therapeutics, Inc. (RAPT - 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 60 days, estimates for Acrivon Therapeutics’ 2024 loss per share have narrowed from $3.30 to $2.47. Loss per share estimates for 2025 have narrowed from $3.13 to $2.55. Year to date, shares of ACRV have surged 34.3%.
ACRV’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining one occasion, the average surprise being 3.56%.
In the past 60 days, estimates for Aligos Therapeutics’ 2024 loss per share have narrowed from 84 cents to 73 cents, while loss per share estimates for 2025 have narrowed from 82 cents to 71 cents. Year to date, shares of ALGS have declined 32%.
Aligos Therapeutics’ earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, the average surprise being 7.83%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $3.19 to $2.93. Loss per share estimates for 2025 have narrowed from $2.40 to $2.05. Year to date, shares of RAPT have plunged 87.4%.
RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.