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Merus (MRUS) Stock Up on FDA's Fast Track Tag for Zenocutuzumab

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Netherlands-based oncology company, Merus N.V. MRUS 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%.

price chart for MRUS
price chart for MRUS


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 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 and Halozyme Therapeutics, Inc. HALO, 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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Alkermes plc (ALKS) : Free Stock Analysis Report
 
Incyte Corporation (INCY) : Free Stock Analysis Report
 
Halozyme Therapeutics, Inc. (HALO) : Free Stock Analysis Report
 
Merus N.V. (MRUS) : Free Stock Analysis Report
 
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