Merus N.V. Announces Zenocutuzumab Granted Second Breakthrough Therapy Designation By The U.S. Food & Drug Administration
Portfolio Pulse from Happy Mohamed
Merus N.V. (NASDAQ:MRUS) has been granted a second Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for its drug zenocutuzumab (Zeno) for the treatment of NRG1+ non-small cell lung cancer. This follows a previous BTD for the treatment of NRG1+ pancreatic cancer. The BTD is supported by data from the ongoing phase 1/2 eNRGy trial and Early Access Program (EAP). Merus plans to engage in expedited discussions with the FDA and provide an update on the path and timeline to a potential Biologics License Application (BLA) submission.
July 05, 2023 | 8:03 pm
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Merus N.V. has received a second Breakthrough Therapy Designation from the FDA for its drug Zeno, potentially expediting its development and review. This could lead to a faster path to commercialization, positively impacting the company's stock.
The FDA's Breakthrough Therapy Designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. This second designation for Merus' Zeno indicates strong potential for the drug, which could lead to faster commercialization and increased revenues for the company. This is likely to have a positive impact on Merus' stock in the short term.
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