Spruce Biosciences, Inc. Stock Price, News & Analysis

Spruce Biosciences (NASDAQ: SPRB) announced the U.S. FDA has granted Breakthrough Therapy Designation to tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo Syndrome Type B (MPS IIIB).

FDA confirmed CSF HS‑NRE as a surrogate biomarker reasonably likely to predict clinical benefit and usable for accelerated approval. Integrated long‑term clinical data reportedly show normalization of CSF HS‑NRE and stabilization of cortical grey matter volume and cognitive function in children with MPS IIIB. Spruce said a Biologics License Application (BLA) submission for TA‑ERT remains on track for Q1 2026.

Spruce Biosciences (Nasdaq: SPRB), a late-stage biopharmaceutical company developing novel therapies for neurological disorders, has announced the resumption of its stock trading on the Nasdaq Capital Market effective September 15, 2025. The company's shares will trade under the ticker symbol "SPRB" with CUSIP 85209E 208.

Spruce Biosciences (OTCQB: SPRB) reported Q2 2025 financial results and significant clinical progress. The company's lead candidate, TA-ERT enzyme replacement therapy, demonstrated strong long-term efficacy and safety data in Sanfilippo Syndrome Type B (MPS IIIB) patients over a five-year period, with plans to submit a biologics license application in Q1 2026.

Key clinical findings show 91.5 ng/mL reduction in CSF HS-NRE levels and significantly higher cognitive scores in treated patients. The company also announced the first patient dosing in the Phase 2 TAMARIND trial of tildacerfont for Major Depressive Disorder, with topline results expected in 1H 2026.

Financially, Spruce reported $16.4 million in cash as of June 30, 2025, sufficient to fund operations through year-end. The company implemented a 1-for-75 reverse stock split and anticipates Nasdaq Capital Market relisting following compliance with minimum bid price requirements.

Spruce Biosciences (OTCQB: SPRB) announced significant long-term clinical data for tralesinidase alfa enzyme replacement therapy (TA-ERT) in treating Sanfilippo Syndrome Type B (MPS IIIB). The integrated data from multiple clinical studies spanning five years demonstrated profound efficacy and safety.

Key findings include a 91.5 ng/mL reduction in CSF HS-NRE levels from baseline (p<0.0001), with most patients achieving normalization within eight weeks of treatment. The FDA confirmed CSF HS-NRE as a surrogate biomarker for accelerated approval. The therapy showed significant cognitive function preservation, with treated patients showing stable BSID-C scores compared to declining scores in untreated patients. At age 10, treated patients showed a 34.66-point higher BSID-C score (p<0.0001).

Safety data over 7.3 years showed an adequate profile, with no deaths reported. Common side effects included vomiting (100%), pyrexia (90.9%), and upper respiratory tract infection (77.3%).

Spruce Biosciences (OTCQB: SPRB), a late-stage biopharmaceutical company, has announced a 1-for-75 reverse stock split effective August 4, 2025, at 5:00 p.m. Eastern Time. The split aims to regain Nasdaq Capital Market compliance by meeting minimum bid price requirements.

The reverse split will reduce outstanding shares from 42.2 million to approximately 0.6 million. Trading on a split-adjusted basis will begin August 5, 2025, under the same symbol "SPRB" but with a new CUSIP number (85209E208). Nasdaq relisting is anticipated after maintaining the required minimum bid price for 20 consecutive trading days.

Proportionate adjustments will be made to outstanding stock options, restricted stock units, and warrants. Computershare Inc. will serve as the exchange agent, with fractional shares settled in cash.

Spruce Biosciences (SPRB) has received conditional approval from Nasdaq to resume trading on the Nasdaq Capital Market, with the requirement to meet minimum bid price requirements by August 5, 2025. The company plans to achieve compliance through a reverse stock split, which requires stockholder approval at the upcoming 2025 Annual Meeting. The Board advocates for the reverse split (Proposal No. 3) to regain Nasdaq compliance, potentially increase investor interest, attract institutional investors currently restricted from low-priced stocks, and improve stock coverage by analysts. Stockholders of record as of May 30, 2025, can vote until July 21, 2025, with the virtual Annual Meeting scheduled for July 22, 2025.

Spruce Biosciences (OTC: SPRB) reported Q1 2025 financial results and provided key updates. The company acquired Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) for treating Sanfilippo Syndrome Type B (MPS IIIB), with BLA submission planned for 1H 2026. TA-ERT has received Fast Track, Rare Pediatric Disease, and Orphan Drug Designations in US and EU. The FDA confirmed HS-NRE as a surrogate biomarker for accelerated approval. Additionally, HMNC will conduct a Phase 2 study of tildacerfont for Major Depressive Disorder. Financial highlights: Cash position of $25.6 million as of March 31, 2025, Q1 R&D expenses of $10.8 million, G&A expenses of $3.7 million, and net loss of $14.0 million.

Spruce Biosciences (NASDAQ: SPRB) has announced a strategic transformation with the acquisition of tralesinidase alfa enzyme replacement therapy (TA-ERT) for treating Sanfilippo Syndrome Type B (MPS IIIB). The company plans to submit a Biologics License Application (BLA) to the FDA in the first half of 2026.

TA-ERT has shown promising results in clinical studies, significantly normalizing cerebral spinal fluid heparan sulfate levels over five years. The FDA has confirmed that this biomarker could serve as a basis for accelerated approval. The therapy has received fast-track designation, rare pediatric disease designation, and orphan drug status in both the U.S. and EU.

Financially, Spruce reported $38.8 million in cash and cash equivalents as of December 31, 2024, with an expected runway through the end of 2025. The company has 42.2 million shares outstanding and 21.4 million shares reserved for warrants and equity securities.

Spruce Biosciences (NASDAQ: SPRB) announced disappointing topline results from two clinical trials evaluating tildacerfont for Congenital Adrenal Hyperplasia (CAH). The CAHmelia-204 Phase 2b study failed to meet its primary endpoint of reducing glucocorticoid usage in adult CAH patients. The trial showed a minimal placebo-adjusted reduction of 0.7mg in daily glucocorticoid dose.

The CAHptain-205 Phase 2 study suggested that higher doses and twice-daily (BID) dosing may be necessary for efficacy. While tildacerfont was generally safe and well-tolerated in both trials, the company will discontinue these clinical trials and wind down its investment in tildacerfont for CAH treatment while evaluating strategic options and implementing cost-reduction measures.