Spruce Biosciences Inc. (SPRB) shares advanced 4.1% in pre-market trading to $64 on Wednesday, extending gains after the biopharmaceutical company reported progress in regulatory discussions with the U.S. Food and Drug Administration.
The upward move follows the completion of two pre-Biologics License Application (BLA) meetings with the FDA, which Spruce described as constructive. These discussions support the company’s plan to submit a BLA for tralesinidase alfa enzyme replacement therapy (TA-ERT) targeting Sanfilippo Syndrome Type B in the fourth quarter of 2026. The FDA indicated that Spruce’s drug substance and drug product analytical comparability strategies were deemed reasonable during the meetings.
Analysts at H.C. Wainwright maintained a Buy rating and $150 price target on Spruce shares, while the broader analyst consensus remained a Strong Buy. Price targets among covering firms range from $104 to $230. Guggenheim and Citizens reduced their targets following the company’s second-quarter results, which were released earlier this month.
The Q2 report also included the announcement of a $5.5 million strategic investment from the Cure Sanfilippo Foundation and the National MPS Society. Spruce’s shares have traded between $7 and $240 over the past 52 weeks.
Broader equity benchmarks showed modest gains, with the Nasdaq Composite up 1.2% and the S&P 500 adding 0.5% during the session.
