We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Merck KGaA's Tepotinib Gets Fast Track Designation in Japan
Read MoreHide Full Article
Merck KGaA (MKGAF - Free Report) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted SAKIGAKE 'fast-track' designation to its pipeline candidate, tepotinib. The company is developing the candidate for the treatment of advanced non-small cell lung cancer (“NSCLC”).
The SAKIGAKE designation is granted to expedite a candidate’s development and review in Japan and focuses on new or unmet areas and regenerative medicines.
Merck KGaA’s shares have underperformed the industry so far this year. The stock has lost 14.8% compared with the industry’s decline of 4.6% in that period.
The designation was granted to tepotinib based on data from a phase II study evaluating it in NSCLC patients with MET exon 14 skipping mutations. There is no approved treatment for this indication.
Data from the study will be presented at a future medical congress.
Apart from tepotinib, Merck KGaA‘s oncology pipeline includes M7824, which is a bifunctional immunotherapy as it simultaneously blocks 2 immuno-inhibitory pathways that are commonly used by cancer cells. The company is evaluating the candidate in several tumors. However, the most advanced candidate in oncology pipeline, avelumab, is being developed in collaboration with Pfizer (PFE - Free Report) in several indications, including lung, gastric, ovarian and kidney cancer.
Per the press release, lung cancer is the most common cancer globally. NSCLC occurs in 80% to 85% of lung cancer patients. However, tepotinib targets only 2% to 3% of NSCLC patients, who have MET exon 14 skipping mutations.
However, several big pharma companies are already marketing their drugs to treat NSCLC. These include Merck’s (MRK - Free Report) anti-PD-1 therapy, Keytruda; Pfizer’s Xalkori and Bristol-Myers’ (BMY - Free Report) PD-1 immune checkpoint inhibitor, Opdivo.
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
Image: Bigstock
Merck KGaA's Tepotinib Gets Fast Track Designation in Japan
Merck KGaA (MKGAF - Free Report) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted SAKIGAKE 'fast-track' designation to its pipeline candidate, tepotinib. The company is developing the candidate for the treatment of advanced non-small cell lung cancer (“NSCLC”).
The SAKIGAKE designation is granted to expedite a candidate’s development and review in Japan and focuses on new or unmet areas and regenerative medicines.
Merck KGaA’s shares have underperformed the industry so far this year. The stock has lost 14.8% compared with the industry’s decline of 4.6% in that period.
The designation was granted to tepotinib based on data from a phase II study evaluating it in NSCLC patients with MET exon 14 skipping mutations. There is no approved treatment for this indication.
Data from the study will be presented at a future medical congress.
Apart from tepotinib, Merck KGaA‘s oncology pipeline includes M7824, which is a bifunctional immunotherapy as it simultaneously blocks 2 immuno-inhibitory pathways that are commonly used by cancer cells. The company is evaluating the candidate in several tumors. However, the most advanced candidate in oncology pipeline, avelumab, is being developed in collaboration with Pfizer (PFE - Free Report) in several indications, including lung, gastric, ovarian and kidney cancer.
Per the press release, lung cancer is the most common cancer globally. NSCLC occurs in 80% to 85% of lung cancer patients. However, tepotinib targets only 2% to 3% of NSCLC patients, who have MET exon 14 skipping mutations.
However, several big pharma companies are already marketing their drugs to treat NSCLC. These include Merck’s (MRK - Free Report) anti-PD-1 therapy, Keytruda; Pfizer’s Xalkori and Bristol-Myers’ (BMY - Free Report) PD-1 immune checkpoint inhibitor, Opdivo.
Merck KGaA Price
Merck KGaA Price | Merck KGaA Quote
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
It's not the one you think.
See This Ticker Free >>