- Needham writes that Merus NV (NASDAQ:MRUS) has enough data to initiate an FDA marketing application filing in mid-2022 after presenting Zenocutuzumab (Zeno) data in NRG1-fusion (NRG1+) Cancer.
- The analyst says that the data was in line with what was presented in ASCO 2021 with no surprises but noted that Merus's undisclosed discussions with the FDA is the only missing piece of the puzzle to understand the approvability of the drug fully.
- 70% of patients saw tumor reduction with an ORR of 34% (PDAC: 42%, NSCLC: 35%). The median time to response was 1.8 months, with 6.3 months as the median duration of exposure.
- Commercialization planning is underway with both partnership and go-alone models.
- Identifying patients is a bottleneck for the widespread use of Zeno as the SoC for NRG1 fusion patients. Management mentioned that 60% of NSCLC get genetically tested, while this number is 30% for PDAC.
- Merus needs plans to increase genetic testing, particularly in PDAC, for successful commercialization.
- Needham estimates sales of over $650 million by 2030 with a risk adjustment of 55% POS.
- Price Action: MRUS shares are up 2.72% at $21.49 during the market session on the last check Monday.
