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 reports developments as a late-stage biopharmaceutical company focused on novel therapies for neurological disorders with significant unmet medical need. Its recurring news centers on tralesinidase alfa enzyme replacement therapy, or TA-ERT, for Sanfilippo Syndrome Type B (MPS IIIB), including clinical data presentations, FDA interactions and regulatory planning for the program.
Company updates also cover financial results, capital actions involving common stock and pre-funded warrants, investor conference participation, and additions to commercial leadership as Spruce builds capabilities around a potential rare-disease launch.
Spruce Biosciences (Nasdaq: SPRB) appointed Daven Mody, Pharm.D., as Senior Vice President, Regulatory and Quality, and Bruno Gagnon, B.Pharm., M.Sc., as Senior Vice President, Clinical Development Operations, effective February 2, 2026.
The hires bring regulatory and rare‑disease clinical operations experience to support a planned BLA submission and a confirmatory study for tralesinidase alfa (TA‑ERT) in Sanfilippo Syndrome Type B (MPS IIIB). Each executive received inducement restricted stock units for 5,500 shares vesting equally over four years, approved under Nasdaq Listing Rule 5635(c)(4).
Spruce Biosciences (Nasdaq: SPRB) will present long‑term clinical data for tralesinidase alfa enzyme replacement therapy (TA‑ERT) at WORLDSymposium Feb 2–6, 2026 in San Diego.
Presentations on Feb 5, 2026 detail a profound, durable reduction of heparan sulfate (HS), stabilization of cognitive function and cortical gray matter volume, and a sibling comparison showing divergent neurocognitive outcomes with and without TA‑ERT.
Harbour BioMed exercised a warrant to acquire common stock in Spruce Biosciences (Nasdaq: SPRB), resulting in Harbour BioMed holding approximately 3.8% of Spruce's outstanding shares and approximately 3.1% of Spruce's fully diluted shares as of Sept 30, 2025. The warrant was issued in connection with a license and collaboration between HBM Alpha Therapeutics and Spruce to advance SPR202, an anti‑corticotropin‑releasing hormone monoclonal antibody for disorders including congenital adrenal hyperplasia. Harbour BioMed framed the exercise as a move to deepen a strategic partnership beyond a licensor‑licensee relationship to align development incentives.
Spruce Biosciences (Nasdaq: SPRB) entered a loan facility with Avenue Capital for up to $50 million, including an initial funded tranche of $15 million expected around January 9, 2026. The 42-month facility has three additional tranches totaling up to $35 million that are contingent on achievement of regulatory and commercial milestones tied to the planned BLA filing and potential launch of tralesinidase alfa enzyme replacement therapy (TA-ERT) for MPS IIIB. Spruce reported preliminary cash and cash equivalents of $48.9 million as of December 31, 2025 and expects the initial draw to extend its cash runway into 2027 while accelerating pre-launch commercial activities.
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.