Spruce Biosciences (SPRB, Financial) has unveiled a fresh corporate strategy focused on the acquisition of tralesinidase alfa, an enzyme replacement therapy aimed at tackling Sanfilippo Syndrome Type B. The company plans to seek accelerated approval in the United States for this therapy, known as TA-ERT, based on existing clinical and non-clinical data. As part of this process, Spruce will launch a confirmatory trial to support the Biologics License Application (BLA) submission with the FDA.
Upon receiving approval, Spruce intends to establish a specialized team to market and support the commercialization of TA-ERT. This strategy leverages a focused approach due to the concentrated number of clinicians who treat MPS IIIB patients. Spruce plans to implement patient-centric initiatives alongside their commercialization efforts.
The company's vision extends beyond the U.S., as they aim to introduce TA-ERT and other investigational products across developed regions like the European Union, UK, Latin America, and Asia. In these regions, Spruce plans to either set up its own commercial organizations or collaborate with strategic partners and third-party distributors.
Spruce emphasizes developing therapies for diseases with clear biological pathways, believing this enhances the likelihood of successful drug development. The exclusive worldwide license rights to TA-ERT and other enzyme replacement products were acquired through an agreement with BioMarin Pharmaceutical (BMRN).
TA-ERT, crafted to serve as an enzyme replacement for MPS IIIB patients, will enter the BLA submission stage in the first half of 2026. The fusion protein incorporates modified human insulin-like growth factor 2. The FDA has recognized its potential by granting fast-track, rare pediatric disease, and orphan drug designations in both the U.S. and EU. In March 2024, the FDA confirmed that existing data is sufficient for a BLA submission and provided recommendations for the confirmatory trial design.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 3 analysts, the average target price for Spruce Biosciences Inc (SPRB, Financial) is $1.83 with a high estimate of $3.00 and a low estimate of $1.00. The average target implies an upside of 483.12% from the current price of $0.31. More detailed estimate data can be found on the Spruce Biosciences Inc (SPRB) Forecast page.
Based on the consensus recommendation from 5 brokerage firms, Spruce Biosciences Inc's (SPRB, Financial) average brokerage recommendation is currently 3.0, indicating "Hold" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
