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) launched MPS3BStudy.com, an information and interest‑registration website for families and caregivers of children with Sanfilippo Syndrome Type B (MPS IIIB). The site covers disease basics, investigational tralesinidase alfa enzyme replacement therapy (TA-ERT), and details of a planned Expanded Access Program (EAP) and TrAnsform confirmatory study.
The TA-ERT EAP is an open-label U.S. program expected to enroll about 10 children with attenuated or severe MPS IIIB, while the TrAnsform randomized confirmatory study plans to enroll about 14 children with severe MPS IIIB. Both programs are expected to initiate as early as the fourth quarter of 2026.
Spruce Biosciences (Nasdaq: SPRB) reported successful completion of two pre-BLA meetings with the FDA supporting its plan to submit a biologics license application (BLA) in the fourth quarter of 2026 for tralesinidase alfa enzyme replacement therapy (TA-ERT) to treat Sanfilippo Syndrome Type B (MPS IIIB).
The FDA found Spruce’s chemistry, manufacturing and controls (CMC) analytical comparability strategies reasonable after technology transfer to a leading global biologics manufacturer and aligned with the overall content and format of the planned BLA, including integrated efficacy and safety summaries. Spruce has completed commercial-scale technology transfer, manufactured registrational drug product batches, and produced the first process performance qualification (PPQ) batch, with the second PPQ batch expected in Q4 2026. The FDA has maintained support for an accelerated approval pathway based on reduction of cerebrospinal fluid heparan sulfate non-reducing ends (CSF HS-NRE), with a confirmatory study allowed to start during BLA review. TA-ERT holds multiple U.S. expedited and orphan designations and may qualify for a rare pediatric disease priority review voucher if approved.
Spruce Biosciences (Nasdaq: SPRB) reported second quarter 2026 results and advanced its lead candidate tralesinidase alfa (TA-ERT) for mucopolysaccharidosis type IIIB (MPS IIIB). The company plans a BLA submission in Q4 2026, seeking FDA accelerated approval using CSF HS-NRE as a surrogate endpoint, and expects to initiate the FDA-requested TrAnsform confirmatory study in Q4 2026 in approximately 14 young children with severe MPS IIIB.
Spruce announced a $5.5 million strategic investment from Cure Sanfilippo Foundation and the National MPS Society to partially fund a U.S. Expanded Access Program enrolling about 10 patients, targeted to start in Q4 2026. Leadership was strengthened with the appointments of Adrian Quartel, M.D., as Chief Medical Officer and Jessica Cohen Pfeffer, M.D., as Vice President, Clinical Development.
Cash and cash equivalents were $96.3 million on June 30, 2026, up from $48.9 million at year-end 2025, which Spruce believes funds operations and debt obligations into the second half of 2027. Second quarter 2026 operating expenses were $16.5 million, and net loss was $16.2 million, or $(6.68) per share; six-month 2026 net loss was $28.5 million versus $16.1 million in the prior-year period.
Spruce Biosciences (Nasdaq: SPRB) announced a combined $5.5 million strategic investment from Cure Sanfilippo Foundation and the National MPS Society. According to Spruce Biosciences, proceeds will partially fund the Tralesinidase Alfa Enzyme Replacement Therapy (TA-ERT) Expanded Access Program (EAP) for Sanfilippo Syndrome Type B (MPS IIIB).
The planned U.S. TA-ERT EAP is an open-label, single-arm early access program for children with attenuated and severe MPS IIIB who are ineligible for the confirmatory study. It is expected to enroll about 10 participants, treated weekly via intracerebroventricular delivery, and may start as early as Q4 2026.
Spruce Biosciences (Nasdaq: SPRB) appointed Jessica Cohen Pfeffer, M.D., as Vice President, Clinical Development, effective August 3, 2026. She brings over a decade of biopharmaceutical experience in clinical development, product portfolio development and medical affairs, including extensive work on enzyme replacement therapies for rare pediatric neurodegenerative and mucopolysaccharidosis (MPS) disorders.
According to the company, Dr. Cohen Pfeffer will support the planned BLA submission for tralesinidase alfa enzyme replacement therapy (TA-ERT) in Sanfilippo Syndrome Type B (MPS IIIB) and potential commercialization. As an employment inducement, she received 3,800 RSUs vesting over four years under Spruce’s 2026 Inducement Plan, subject to continued service.
Spruce Biosciences (Nasdaq: SPRB) appointed Adrian Quartel, M.D., FFPM, as Chief Medical Officer, effective July 27, 2026. He brings over 25 years of global clinical development, pharmacovigilance and medical affairs experience, including leadership in launching multiple enzyme replacement therapies for rare pediatric and genetic disorders.
According to Spruce Biosciences, Dr. Quartel’s expertise is expected to support a planned BLA filing in Q4 2026 for tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo Syndrome Type B (MPS IIIB). As an inducement grant, he received 13,000 RSUs vesting over four years under the 2026 Inducement Plan.
Spruce Biosciences (Nasdaq: SPRB) announced that CEO Javier Szwarcberg, M.D., M.P.H., will take part in a fireside chat at the B. Riley Securities 2026 Mind, Muscle & Vision Healthcare Summit on July 16, 2026, at the InterContinental Boston in Boston, MA.
Participation is by invitation only, and interested investors can request in-person meetings through B. Riley Securities or the summit email contact.
Spruce Biosciences (Nasdaq: SPRB) has been added to the Russell 3000® Index, effective with the opening of U.S. equity markets on the 2026 reconstitution date. This also brings automatic inclusion in the Russell 2000® Index as a small-cap constituent.
The company is a late-stage, precommercial biopharma advancing tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo syndrome type B (MPS IIIB), with a planned BLA submission and potential U.S. FDA approval and launch.
Spruce Biosciences (Nasdaq: SPRB) appointed Agnieszka “AJ” Jurecka, M.D., Ph.D., MPH, as Vice President, Medical Affairs to lead medical affairs and scientific engagement for tralesinidase alfa enzyme replacement therapy (TA-ERT) for Sanfilippo syndrome type B.
On June 22, 2026, she also received 3,800 RSUs vesting over four years under Spruce’s 2026 Inducement Plan.
Spruce Biosciences (Nasdaq: SPRB) appointed Eric Jordan as Vice President, Marketing and Tina Gullotta as Vice President, Finance and Corporate Controller. Both bring over 20 years of biotech and finance experience as Spruce prepares for a potential U.S. FDA approval and commercial launch of TA-ERT for Sanfilippo Syndrome Type B.
On June 15, 2026, each executive received an inducement grant of 3,500 RSUs, vesting annually over four years under the 2026 Inducement Plan.