Craig-Hallum bullish on Spruce Biosciences, initiates with a Buy

AS previously reported, Craig-Hallum initiated coverage of Spruce Biosciences (SPRB) with a Buy rating and $140 price target. The firm notes the company’s TA-ERT is an enzyme replacement therapy for MPS IIIB, an ultra-rare neurodegenerative disease that has no treatments and patients typically die in their teens. TA-ERT is on track for a BLA filing for accelerated approval based on a Phase I/II study that showed normalization of CSF HS-NRE. TA-ERT’s regulatory path is de-risked following the recent approval of Denali Therapeutics ‘ (DNLI) Avlayah, which was based on a similar biomarker endpoint. Craig-Hallum sees an attractive set up with a clear path toward approval in a rare pediatric disease setting with strong commercial comps.