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FDA Expands Merck's (MRK) Welireg Label in Renal Cell Carcinoma
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Merck (MRK - Free Report) announced that the FDA has expanded the label of its oral HIF-2α inhibitor, Welireg (belzutifan), in certain patients with advanced renal cell carcinoma (“RCC”).
Welireg is now approved in the United States to treat adult patients with advanced RCC whose cancer has progressed following treatment with a PD-1/L1 inhibitor and a VEGF-TKI inhibitor. Per management, this approval marks the first time a new treatment has been approved in a novel therapeutic class in advanced RCC since 2015.
Merck aims to introduce Welireg as a new treatment option that can reduce the risk of disease progression or death for an indication with low survival rates.
The FDA’s approval is based on data from the phase III LITESPARK-005 study, which evaluated Welireg in adult patients with advanced RCC that progressed following treatment with a PD-1/L1 checkpoint inhibitor and VEGF-TKI therapy, which was announced in August.
Data from the LITESPARK-005 study showed that treatment with Welireg achieved statistically significant and clinically meaningful improvement in progression-free survival(“PFS”), one of the study’s dual primary endpoints. The study also achieved its secondary endpoint of statistically significant improvement in the objective response rate (“ORR”).
Welireg is already approved in the United States and Europe to treat adult patients with von Hippel-Lindau (“VHL”) disease who require therapy for associated RCC, central nervous system hemangioblastomas or pancreatic neuroendocrine tumors, not requiring immediate surgery.
Merck’s shares have lost 4.6% year to date against the industry’s 5.9% growth.
Image Source: Zacks Investment Research
The LITESPARK-005 study is part of Merck's comprehensive late-stage development program on Welireg in RCC. The program comprises three other late-stage studies – LITESPARK-011, LITESPARK-012 and LITESPARK-022. While LITESPARK-011 and LITESPARK-012 evaluate Welireg in the second-line and treatment-naïve advanced disease settings, respectively, LITESPARK-022 evaluates Welireg in the adjuvant setting.
In a separate press release, Merck, along with partner Moderna (MRNA - Free Report) , reported three-year follow-up data from the phase IIb KEYNOTE study evaluating their investigational individualized neoantigen therapy (INT) candidate mRNA-4157/V940 in melanoma indication.
At a median planned follow-up of approximately three years, treatment with the combination of mRNA-4157 and Keytruda reduced the risk of recurrence or death by 49% compared with those treated with Keytruda alone. Treatment with this mRNA-4157/Keytruda combination also reduced the risk of developing distant metastasis or death by 62%, compared to Keytruda alone.
The above results demonstrate the meaningful benefit of combining mRNA-4157 with Keytruda, compared with Keytruda alone, over a longer period. Earlier in first-half 2023, Moderna/Merck reported two-year follow-up data from the KEYNOTE-942 study wherein treatment with the mRNA-4157/Keytruda combination cut the risks of recurrence/death by 44% and the risk of distant metastasis or death by 65%.
Merck and Moderna entered a strategic partnership in 2016 to develop and commercialize mRNA-based therapeutics to treat various types of cancer. Last year, Merck exercised its option to develop the INT with Moderna. Per the terms of the collaboration, the companies will share costs and profits equally.
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 9.2% 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. Shares of Ocuphire have lost 25.2% 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%.
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FDA Expands Merck's (MRK) Welireg Label in Renal Cell Carcinoma
Merck (MRK - Free Report) announced that the FDA has expanded the label of its oral HIF-2α inhibitor, Welireg (belzutifan), in certain patients with advanced renal cell carcinoma (“RCC”).
Welireg is now approved in the United States to treat adult patients with advanced RCC whose cancer has progressed following treatment with a PD-1/L1 inhibitor and a VEGF-TKI inhibitor. Per management, this approval marks the first time a new treatment has been approved in a novel therapeutic class in advanced RCC since 2015.
Merck aims to introduce Welireg as a new treatment option that can reduce the risk of disease progression or death for an indication with low survival rates.
The FDA’s approval is based on data from the phase III LITESPARK-005 study, which evaluated Welireg in adult patients with advanced RCC that progressed following treatment with a PD-1/L1 checkpoint inhibitor and VEGF-TKI therapy, which was announced in August.
Data from the LITESPARK-005 study showed that treatment with Welireg achieved statistically significant and clinically meaningful improvement in progression-free survival(“PFS”), one of the study’s dual primary endpoints. The study also achieved its secondary endpoint of statistically significant improvement in the objective response rate (“ORR”).
Welireg is already approved in the United States and Europe to treat adult patients with von Hippel-Lindau (“VHL”) disease who require therapy for associated RCC, central nervous system hemangioblastomas or pancreatic neuroendocrine tumors, not requiring immediate surgery.
Merck’s shares have lost 4.6% year to date against the industry’s 5.9% growth.
Image Source: Zacks Investment Research
The LITESPARK-005 study is part of Merck's comprehensive late-stage development program on Welireg in RCC. The program comprises three other late-stage studies – LITESPARK-011, LITESPARK-012 and LITESPARK-022. While LITESPARK-011 and LITESPARK-012 evaluate Welireg in the second-line and treatment-naïve advanced disease settings, respectively, LITESPARK-022 evaluates Welireg in the adjuvant setting.
In a separate press release, Merck, along with partner Moderna (MRNA - Free Report) , reported three-year follow-up data from the phase IIb KEYNOTE study evaluating their investigational individualized neoantigen therapy (INT) candidate mRNA-4157/V940 in melanoma indication.
At a median planned follow-up of approximately three years, treatment with the combination of mRNA-4157 and Keytruda reduced the risk of recurrence or death by 49% compared with those treated with Keytruda alone. Treatment with this mRNA-4157/Keytruda combination also reduced the risk of developing distant metastasis or death by 62%, compared to Keytruda alone.
The above results demonstrate the meaningful benefit of combining mRNA-4157 with Keytruda, compared with Keytruda alone, over a longer period. Earlier in first-half 2023, Moderna/Merck reported two-year follow-up data from the KEYNOTE-942 study wherein treatment with the mRNA-4157/Keytruda combination cut the risks of recurrence/death by 44% and the risk of distant metastasis or death by 65%.
Merck and Moderna entered a strategic partnership in 2016 to develop and commercialize mRNA-based therapeutics to treat various types of cancer. Last year, Merck exercised its option to develop the INT with Moderna. Per the terms of the collaboration, the companies will share costs and profits equally.
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). A couple of better-ranked stocks in the overall healthcare sector include Galapagos (GLPG - Free Report) and Ocuphire Pharma (OCUP - Free Report) , each sporting 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, 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 9.2% 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. Shares of Ocuphire have lost 25.2% 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%.