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FDA Accepts Merck (MRK) sNDA for Welireg in Renal Cell Carcinoma
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Merck (MRK - Free Report) announced that the FDA accepted its regulatory filing seeking label expansion for Welireg (belzutifan) in specific renal cell carcinoma (“RCC”) patients. The agency has granted priority review to this filing and a final decision is expected before Jan 17, 2024.
The sNDA seeks approval for Welireg to treat adult patients with advanced RCC whose cancer has progressed following treatment with immune checkpoint and anti-angiogenic therapies.
An oral HIF-2α inhibitor, Welireg is 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.
The filing is supported by 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 announcedlast month.
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”). No new safety signals were reported in the study, and the safety profile of Welireg was in line with observations in its previous studies.
Though a favorable trend was observed in the study’s other primary endpoint of overall survival (“OS”), it did not reach statistical significance. The study investigators will test the OS endpoint at a subsequent analysis. Merck intends to report data from the study at a future medical meeting.
Per management, the LITESPARK-005 is the first late-stage study to show positive results in patients with advanced RCC who received a checkpoint inhibitor and a VEGF-TKI therapy. With a potential label expansion in advanced RCC, 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.
Merck’s shares have lost 3.2% year to date against the industry’s 7.4% 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.
Merck’s oncology portfolio is highly dependent on Keytruda, its blockbuster anti-PD-1 therapy, which accounted for over 40% of the company’s revenues in the first half of 2023. With concerns over Keytruda’s potential loss of exclusivity post-2028, a label expansion to drugs like Welireg will enable the company to narrow down its dependence on the anti-PD-1 therapy.
In the past 60 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of Annovis have lost 20.0%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
In the past 30 days, estimates for Aprea Therapeutics’ 2023 loss per share have improved from $4.65 to $3.26. During the same period, the loss estimates per share for 2024 have narrowed down from $1.82 to $1.23. Year to date, shares of Aprea have lost 38.1%.
Earnings of Aprea Therapeutics beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 43.05%. In the last reported quarter, Aprea Therapeutics’ earnings beat estimates by 39.16%.
In the past 30 days, estimates for Novartis’ 2023 earnings per share have risen from $6.81 to $6.92. During the same period, the estimates per share for 2024 increased from $7.32 to $7.52. Year to date, shares of Novartis have risen 13.4%.
Earnings of Novartis beat estimates in each of the trailing four quarters, witnessing an average earnings surprise of 6.56%. In the last reported quarter, Novartis’ earnings beat estimates by 8.93%.
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FDA Accepts Merck (MRK) sNDA for Welireg in Renal Cell Carcinoma
Merck (MRK - Free Report) announced that the FDA accepted its regulatory filing seeking label expansion for Welireg (belzutifan) in specific renal cell carcinoma (“RCC”) patients. The agency has granted priority review to this filing and a final decision is expected before Jan 17, 2024.
The sNDA seeks approval for Welireg to treat adult patients with advanced RCC whose cancer has progressed following treatment with immune checkpoint and anti-angiogenic therapies.
An oral HIF-2α inhibitor, Welireg is 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.
The filing is supported by 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 announcedlast month.
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”). No new safety signals were reported in the study, and the safety profile of Welireg was in line with observations in its previous studies.
Though a favorable trend was observed in the study’s other primary endpoint of overall survival (“OS”), it did not reach statistical significance. The study investigators will test the OS endpoint at a subsequent analysis. Merck intends to report data from the study at a future medical meeting.
Per management, the LITESPARK-005 is the first late-stage study to show positive results in patients with advanced RCC who received a checkpoint inhibitor and a VEGF-TKI therapy. With a potential label expansion in advanced RCC, 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.
Merck’s shares have lost 3.2% year to date against the industry’s 7.4% 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.
Merck’s oncology portfolio is highly dependent on Keytruda, its blockbuster anti-PD-1 therapy, which accounted for over 40% of the company’s revenues in the first half of 2023. With concerns over Keytruda’s potential loss of exclusivity post-2028, a label expansion to drugs like Welireg will enable the company to narrow down its dependence on the anti-PD-1 therapy.
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 Annovis Bio (ANVS - Free Report) , Aprea Therapeutics (APRE - Free Report) and Novartis (NVS - 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, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of Annovis have lost 20.0%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
In the past 30 days, estimates for Aprea Therapeutics’ 2023 loss per share have improved from $4.65 to $3.26. During the same period, the loss estimates per share for 2024 have narrowed down from $1.82 to $1.23. Year to date, shares of Aprea have lost 38.1%.
Earnings of Aprea Therapeutics beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 43.05%. In the last reported quarter, Aprea Therapeutics’ earnings beat estimates by 39.16%.
In the past 30 days, estimates for Novartis’ 2023 earnings per share have risen from $6.81 to $6.92. During the same period, the estimates per share for 2024 increased from $7.32 to $7.52. Year to date, shares of Novartis have risen 13.4%.
Earnings of Novartis beat estimates in each of the trailing four quarters, witnessing an average earnings surprise of 6.56%. In the last reported quarter, Novartis’ earnings beat estimates by 8.93%.