Welcome to our dedicated page for Spruce Biosciences news (Ticker: SPRB), a resource for investors and traders seeking the latest updates and insights on Spruce Biosciences stock.
Spruce Biosciences, Inc. (SPRB) generates news that centers on its late-stage biopharmaceutical efforts to develop and commercialize therapies for neurological disorders with significant unmet medical need. Company announcements focus heavily on tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo Syndrome Type B (MPS IIIB), an ultra-rare, serious, and fatal genetic disease for which Spruce states there are currently no FDA-approved treatments.
News coverage for SPRB commonly includes clinical and regulatory milestones. Examples from company releases include integrated long-term clinical data for TA-ERT, demonstrating profound and durable reductions in cerebral spinal fluid heparan sulfate non-reducing end (CSF HS-NRE) and stabilization of cognition and cortical grey matter volume, as well as the U.S. FDA granting Breakthrough Therapy Designation for TA-ERT and confirming CSF HS-NRE as a surrogate biomarker reasonably likely to predict clinical benefit.
Investors also see financing and capital markets updates in Spruce’s news flow. The company has reported a private placement with institutional investors expected to provide approximately $50.0 million in gross proceeds to advance TA-ERT, and a loan and security agreement with Avenue Venture Opportunities Fund II, L.P. providing access to up to $50.0 million in term loans tied to regulatory and commercial milestones. Additional headlines cover reverse stock split actions, conditional approval and resumption of trading on the Nasdaq Capital Market, and related listing matters.
Corporate governance and pipeline diversification are further themes in SPRB news. Spruce has announced board changes, including the appointment of Keli Walbert to its board of directors and compensation committee, as well as director resignations. The company has also issued updates on tildacerfont, being studied in major depressive disorder under a collaboration with HMNC Holding GmbH, and referenced SPR202 for congenital adrenal hyperplasia. For readers tracking SPRB, this news page provides a centralized view of the company’s clinical progress, regulatory interactions, financing events, and governance developments.
Spruce Biosciences (Nasdaq: SPRB) appointed Keli Walbert to its Board of Directors on December 15, 2025. Walbert brings more than 20 years of commercial leadership and rare disease launch experience, most recently serving as Executive Vice President, U.S. Commercial at Horizon Therapeutics where she oversaw commercial strategy for more than 10 marketed brands and led the launch of TEPEZZA.
The appointment comes as Spruce prepares for a potential Biologics License Application (BLA) submission for TA-ERT to treat Sanfilippo Syndrome Type B (MPS IIIB); management says Walbert will support the company’s transition toward commercialization and strategic planning ahead of expected regulatory milestones.
Spruce Biosciences (Nasdaq: SPRB) reported Q3 2025 results and corporate updates on November 10, 2025. Key highlights include FDA Breakthrough Therapy designation (Oct 2025) for tralesinidase alfa (TA-ERT), a BLA submission on track for Q1 2026, and a completed $50.0 million private placement (Oct 2025).
The company had $10.7M cash as of September 30, 2025 (excluding the $50.0M proceeds) and says combined funds are expected to finance operations into Q4 2026. Q3 R&D was $5.0M, G&A $3.2M, and net loss for the quarter was $8.2M. The company relisted under SPRB after a 1-for-75 reverse split.
Spruce Biosciences (Nasdaq: SPRB) entered a definitive securities purchase agreement for a private placement expected to raise approximately $50.0 million gross before expenses. The financing covers sale of ~502,181 common shares at $68.00 per share and issuance of pre-funded warrants to buy up to 233,144 shares at $67.99, exercisable for five years.
Proceeds are intended to advance tralesinidase alfa (TA-ERT) toward a BLA submission in Q1 2026 and a potential U.S. commercial launch in late 2026. The private placement is expected to close on or about October 9, 2025, subject to customary conditions, with placement agents and a capital markets advisor named.
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.