BTIG launched coverage of Y-mAbs Therapeutics (NASDAQ:YMAB) with a “buy” rating and $35 price target. The stock closed at $21.60 on Oct. 15.
Y-mAbs is in pivotal trials for the treatment of both primary neuroblastomas, with drug candidate, naxitamab, and their subsequent CNS metastases, with candidate, omburtamab.
The company plans to submit two BLAs around mid-2019. “Both antibodies look more active than current standard of care,” writes analyst Thomas Shrader, adding that both mAbs have breakthrough designation that should each result in a priority review voucher if the mAbs are approved.
The company licensed, lead candidate, naxitamab, from Memorial Sloan Kettering Cancer Center along with two large data sets, both of which suggested an overall response rate (ORR) of around 60% in relapsed/refractory (R/R) neuroblastoma.
Armed with these data, Mr. Shrader said the company agreed on a plan with the FDA to treat an additional 37 R/R NB patients, with a goal of demonstrating an ORR of about 30%.
Y-mAbs’ second drug appears extremely active in an area of medicine with no real standard of care. The FDA-agreed and the requirement for accelerated approval is really a bridging study for a new manufacturing process, Mr. Shrader said, adding, “Data to date make success seem likely.”
