MRUS - Merus slumps 30% as FDA requires more enrollments to support cancer candidate
- Merus N.V. ( NASDAQ: MRUS ) shed ~30% intraday on Thursday after the Dutch biotech said with its Q3 2022 financials that the FDA recommended additional patient enrollment to generate data to support a potential marketing application for bispecific antibody Zenocutuzumab.
- The company is currently recruiting patients for the Phase 1/2 eNRGy trial designed to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer.
- The FDA has given its feedback after the company, seeking to submit a Biologics License Application (BLA) for Zeno in NRG1 fusion (NRG1+) cancer, met the regulator at the end of October.
- Merus ( MRUS ) said it is evaluating the impact of FDA recommendations on the timeline for a BLA filing.
- With its Q2 2022 results, the company said that the FDA feedback suggested that the eNRGy trial design and planned enrollment could support a BLA for the candidate in NRG1+ cancer.
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Merus slumps 30% as FDA requires more enrollments to support cancer candidate