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) completed two Type B meetings with the U.S. FDA and will pursue a BLA for tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo syndrome type B (MPS IIIB).
The FDA indicated CSF HS-NRE could serve as a reasonably likely surrogate endpoint for accelerated approval and requires one DP PPQ batch at submission plus a second DP PPQ batch before midcycle review, shifting the anticipated BLA submission to Q4 2026.
Spruce Biosciences (Nasdaq: SPRB) said CEO Javier Szwarcberg will join a fireside chat at the Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25, 2026 at 3:20 p.m. ET. The session will be webcast live, with an archived replay available on the company's events page for about 90 days.
Spruce Biosciences (Nasdaq: SPRB) reported long-term data showing weekly tralesinidase alfa enzyme replacement therapy (TA-ERT) normalized CSF HS-NRE and stabilized cognitive, communication, and motor outcomes over up to six years versus untreated natural history patients. Approximately 6,000 doses were administered to 22 patients with a safety profile consistent with intracerebroventricular administration. A sibling case comparison showed higher functioning in a treated sibling versus an untreated sibling at similar ages. The company said it will pursue a biologics license application and potential U.S. FDA approval.
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.