Spruce Biosciences

Spruce Biosciences shares rose 4.1% in pre-market trading after H.C. Wainwright confirmed a buy rating and a $150 price target. FDA feedback from two constructive meetings supports the planned BLA submission for tralesinidase alfa (TA-ERT) to treat Sanfilippo type B in Q4 2026. The analyst consensus is "Strong Buy" with price targets between $104 and $230, backed by strategic foundation placements and a risk-on market sentiment. » Plus sur de.investing.com

Spruce Biosciences completed two key pre-BLA meetings with the FDA for the enzyme replacement therapy tralesinidase alfa for Sanfilippo syndrome type B. The FDA found the analytical comparability strategies acceptable and agreed to the planned BLA’s scope and format as well as the structure of the integrated efficacy and safety summaries. Spruce intends to submit the BLA in Q4 2026 under the accelerated approval pathway based on reductions in specific heparan sulfate biomarkers in cerebrospinal fluid; the confirmatory study may begin during review. Technology transfer for commercial manufacture is complete, the first PPQ batch was produced in July 2026, the second batch is expected in Q4 2026 and is planned to be submitted before the midpoint of the BLA review. Tralesinidase alfa has received multiple accelerated regulatory designations in the US, including Breakthrough Therapy and Orphan Drug. » Plus sur de.investing.com

Spruce Biosciences has appointed Dr. med. Adrian Quartel as chief medical officer, effective immediately. Quartel brings more than 25 years of experience in clinical development, pharmacovigilance and medical affairs and previously served as CMO at Zevra Therapeutics as well as in leadership roles at BioMarin, Acer and Adamas. The company plans to submit a regulatory application for the enzyme replacement therapy tralesinidase alfa (TA-ERT) to treat MPS IIIB in the fourth quarter of 2026. Quartel received 13,000 restricted stock units that vest 25% annually over four years. » Plus sur de.investing.com