Netherlands-based oncology company, Merus N.V. (MRUS - Free Report) announced that the FDA has granted a Fast Track designation to its lead pipeline candidate, Zenocutuzumab (Zeno) for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancers) whose disease has progressed on standard of care therapy.
Notably, the FDA provides a Fast Track designation to help the development and faster review of drugs which treat serious and unmet medical conditions.
Shares of Merus were up 28.3% on Friday following the announcement of the news on Thursday. In fact, the stock has rallied 39.2% in the past year compared with the industry’s increase of 9.2%.
The company is evaluating Zeno as monotherapy in the phase I/II eNRGy study for treating patients with NRG1+ cancers. Enrollment is currently ongoing in the study divided in three cohorts – non-small cell lung cancer, pancreatic cancer and other solid tumors. An update for clinical program for Zeno is expected in the second quarter of 2021.
Per the company, NRG1 fusions are rare mutations found in many types of solid tumors, including lung, breast, pancreatic, ovarian as well as colorectal cancers. The FDA has already granted an Orphan Drug designation to Zeno for the treatment of pancreatic cancer.
If successfully developed and upon potential approval, Zeno can serve a market with unmet medical need and become a treatment for addressing patients with NRG1+ cancers.
We remind investors that Merus has a global collaboration and license agreement with Incyte Corporation (INCY - Free Report) for the development and commercialization of up to 11 bispecific and monospecific antibodies using the former’s Biclonics platform.
Merus currently receives reimbursement revenues from Incyte which comprise of the company’s top line.
Zacks Rank & Stocks to Consider
Merus currently carries a Zacks Rank #3 (Hold). Some top-ranked stocks in the biotech sector include Alkermes plc (ALKS - Free Report) and Halozyme Therapeutics, Inc. (HALO - Free Report) , both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ earnings estimates have been revised 8.3% upward for 2021 over the past 60 days. The stock has increased 7.2% in the past year.
Halozyme’s earnings estimates have been revised 3.6% upward for 2021 over the past 60 days. The stock has skyrocketed 132.2% in the past year.
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Netherlands-based oncology company, Merus N.V. (MRUS - Free Report) announced that the FDA has granted a Fast Track designation to its lead pipeline candidate, Zenocutuzumab (Zeno) for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancers) whose disease has progressed on standard of care therapy.
Notably, the FDA provides a Fast Track designation to help the development and faster review of drugs which treat serious and unmet medical conditions.
Shares of Merus were up 28.3% on Friday following the announcement of the news on Thursday. In fact, the stock has rallied 39.2% in the past year compared with the industry’s increase of 9.2%.
The company is evaluating Zeno as monotherapy in the phase I/II eNRGy study for treating patients with NRG1+ cancers. Enrollment is currently ongoing in the study divided in three cohorts – non-small cell lung cancer, pancreatic cancer and other solid tumors. An update for clinical program for Zeno is expected in the second quarter of 2021.
Per the company, NRG1 fusions are rare mutations found in many types of solid tumors, including lung, breast, pancreatic, ovarian as well as colorectal cancers. The FDA has already granted an Orphan Drug designation to Zeno for the treatment of pancreatic cancer.
If successfully developed and upon potential approval, Zeno can serve a market with unmet medical need and become a treatment for addressing patients with NRG1+ cancers.
We remind investors that Merus has a global collaboration and license agreement with Incyte Corporation (INCY - Free Report) for the development and commercialization of up to 11 bispecific and monospecific antibodies using the former’s Biclonics platform.
Merus currently receives reimbursement revenues from Incyte which comprise of the company’s top line.
Zacks Rank & Stocks to Consider
Merus currently carries a Zacks Rank #3 (Hold). Some top-ranked stocks in the biotech sector include Alkermes plc (ALKS - Free Report) and Halozyme Therapeutics, Inc. (HALO - Free Report) , both carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ earnings estimates have been revised 8.3% upward for 2021 over the past 60 days. The stock has increased 7.2% in the past year.
Halozyme’s earnings estimates have been revised 3.6% upward for 2021 over the past 60 days. The stock has skyrocketed 132.2% in the past year.
Just Released: Zacks’ 7 Best Stocks for Today
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 stocks that have beaten the market more than 2X over with a stunning average gain of +24.4% per year.
These 7 were selected because of their superior potential for immediate breakout.
See these time-sensitive tickers now >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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