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Merck (MRK) VHL-Linked Kidney Cancer Drug Gets FDA Priority Tag
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Merck & Co., Inc. (MRK - Free Report) announced that the FDA accepted the new drug application (“NDA”) for its novel investigational candidate, belzutifan. The company is seeking approval of belzutifan, a HIF-2α inhibitor, for the potential treatment of von Hippel-Lindau (“VHL”) disease-associated renal cell carcinoma (“RCC”) in patients who do not require immediate surgery.
With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Sep 15, 2021.
The NDA was based on data from the phase II Study-004 study, which evaluated belzutifan for the given indication. Data from the study showed that treatment with belzutifan demonstrated a confirmed overall response rate of 36.1% in patients with VHL disease-associated RCC.
Per the company, VHL disease is a rare genetic condition for which currently there is no systemic treatment option available. As a matter of fact, around 70% of patients with VHL are likely to develop RCC in their lifetime. Hence, upon potential approval, belzutifan can serve a market with unmet medical need.
Shares of Merck have declined 6.1% so far this year compared with the industry’s decrease of 0.5%.
Notably, belzutifan is also being studied for advanced RCC and other tumor types. The candidate is being investigated in phase III studies, both as monotherapy and as part of a combination regimen in previously-treated patients and as part of a combination regimen as a first-line treatment for advanced clear-cell RCC.
We remind investors that belzutifan is part of Merck’s oncology pipeline. The company’s cancer pipeline mostly consists of label expansion studies of Keytruda, Lynparza [marketed in partnership with AstraZeneca (AZN - Free Report) ] and Lenvima (in partnership with Eisai), which are already marketed for several cancer indications.
Keytruda is being studied in phase-III studies for biliary tract, cervical, gastric, hepatocellular, endometrial, cutaneous squamous cell, mesothelioma, ovarian, prostate and small-cell lung cancers. Merck has collaborated with several companies, including Amgen (AMGN - Free Report) , Incyte, Glaxo and Pfizer (PFE - Free Report) , separately, for the evaluation of Keytruda in combination with other regimens.
Lynparza is also being evaluated in combination with Keytruda for colorectal, NSCLC and colorectal cancer. Lenvima is being studied in combination with Keytruda for bladder, gastric, head and neck squamous cell carcinoma, renal cell carcinoma, melanoma and NSCLC.
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Merck (MRK) VHL-Linked Kidney Cancer Drug Gets FDA Priority Tag
Merck & Co., Inc. (MRK - Free Report) announced that the FDA accepted the new drug application (“NDA”) for its novel investigational candidate, belzutifan. The company is seeking approval of belzutifan, a HIF-2α inhibitor, for the potential treatment of von Hippel-Lindau (“VHL”) disease-associated renal cell carcinoma (“RCC”) in patients who do not require immediate surgery.
With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Sep 15, 2021.
The NDA was based on data from the phase II Study-004 study, which evaluated belzutifan for the given indication. Data from the study showed that treatment with belzutifan demonstrated a confirmed overall response rate of 36.1% in patients with VHL disease-associated RCC.
Per the company, VHL disease is a rare genetic condition for which currently there is no systemic treatment option available. As a matter of fact, around 70% of patients with VHL are likely to develop RCC in their lifetime. Hence, upon potential approval, belzutifan can serve a market with unmet medical need.
Shares of Merck have declined 6.1% so far this year compared with the industry’s decrease of 0.5%.
Notably, belzutifan is also being studied for advanced RCC and other tumor types. The candidate is being investigated in phase III studies, both as monotherapy and as part of a combination regimen in previously-treated patients and as part of a combination regimen as a first-line treatment for advanced clear-cell RCC.
We remind investors that belzutifan is part of Merck’s oncology pipeline. The company’s cancer pipeline mostly consists of label expansion studies of Keytruda, Lynparza [marketed in partnership with AstraZeneca (AZN - Free Report) ] and Lenvima (in partnership with Eisai), which are already marketed for several cancer indications.
Keytruda is being studied in phase-III studies for biliary tract, cervical, gastric, hepatocellular, endometrial, cutaneous squamous cell, mesothelioma, ovarian, prostate and small-cell lung cancers. Merck has collaborated with several companies, including Amgen (AMGN - Free Report) , Incyte, Glaxo and Pfizer (PFE - Free Report) , separately, for the evaluation of Keytruda in combination with other regimens.
Lynparza is also being evaluated in combination with Keytruda for colorectal, NSCLC and colorectal cancer. Lenvima is being studied in combination with Keytruda for bladder, gastric, head and neck squamous cell carcinoma, renal cell carcinoma, melanoma and NSCLC.
Zacks Rank
Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
+1,500% Growth: One of 2021’s Most Exciting Investment Opportunities
In addition to the stocks you read about above, would you like to see Zacks’ top picks to capitalize on the Internet of Things (IoT)? It is one of the fastest-growing technologies in history, with an estimated 77 billion devices to be connected by 2025. That works out to 127 new devices per second.
Zacks has released a special report to help you capitalize on the Internet of Things’s exponential growth. It reveals 4 under-the-radar stocks that could be some of the most profitable holdings in your portfolio in 2021 and beyond.
Click here to download this report FREE >>