Spruce Biosciences, Inc.

Spruce Biosciences Announces Launch of MPS3BStudy.com

Spruce Biosciences launched MPS3BStudy.com, a resource for families and caregivers to learn about and register interest in the TA-ERT Expanded Access Program (EAP) and TrAnsform confirmatory study. Both the EAP and the confirmatory study are expected to initiate in the fourth quarter of 2026, with the EAP targeting approximately 10 participants and the confirmatory study enrolling approximately 14. The company's planned biologics application for TA-ERT is currently under FDA review, with the therapy holding Breakthrough Therapy and Rare Pediatric Disease designations.

•2mo ago

Spruce Biosciences Announces Positive Pre-BLA Meetings with FDA and Confirms BLA Submission for TA-ERT on Track for Q4 2026

Spruce Biosciences reported positive pre-BLA meetings with the FDA, where the agency found the company's CMC strategies reasonable and aligned on the content and format of the planned Biologics License Application for TA-ERT. The company remains on track to submit the BLA in the fourth quarter of 2026 for the treatment of Sanfilippo Syndrome Type B, pursuing an accelerated approval pathway based on reduction of CSF HS-NRE. Operational milestones include the completion of the first Process Performance Qualification batch in July 2026, with the second batch expected in the fourth quarter of 2026.

•2mo ago

Spruce Biosciences Reports Second Quarter 2026 Financial Results and Provides Corporate Updates

Spruce Biosciences reported a Q2 net loss of $16.2 million, or $(6.68) per share, while strengthening its balance sheet with $96.3 million in cash, sufficient to fund operations into the second half of 2027. The company confirmed that the Biologics License Application (BLA) for its lead asset TA-ERT is anticipated in Q4 2026, alongside the initiation of the TrAnsform confirmatory study and an Expanded Access Program. Strategic corporate updates included a $5.5 million investment from patient advocacy foundations and the appointment of Dr. Adrian Quartel as CMO and Dr. Jessica Cohen Pfeffer as VP of Clinical Development.

•2mo ago

Cure Sanfilippo Foundation and National MPS Society Make $5.5 Million Strategic Investment in Spruce Biosciences

Cure Sanfilippo Foundation and the National MPS Society made a combined $5.5 million strategic investment in Spruce Biosciences to partially fund the TA-ERT Expanded Access Program (EAP) for Sanfilippo Syndrome Type B. The open-label EAP is expected to initiate in the fourth quarter of 2026, aiming to enroll approximately 10 U.S. children who are not eligible for the confirmatory study. Management views this investment as a collaboration between industry and the patient community to accelerate access to the investigational therapy ahead of potential regulatory approval.

•2mo ago

Spruce Biosciences Appoints Jessica Cohen Pfeffer, M.D., as Vice President, Clinical Development

Spruce Biosciences appointed Jessica Cohen Pfeffer, M.D., as Vice President of Clinical Development, leveraging her over a decade of experience in enzyme replacement therapies for rare pediatric neurodegenerative disorders. Dr. Cohen Pfeffer joins from BioMarin Pharmaceutical, where she led clinical sciences for Brineura, bringing expertise directly relevant to Spruce's lead asset TA-ERT for Sanfilippo Syndrome Type B. In connection with her employment, she received an inducement award of 3,800 restricted stock units, vesting over four years.

•2mo ago

Spruce Biosciences Appoints Adrian Quartel, M.D., FFPM, as Chief Medical Officer

Spruce Biosciences appointed Adrian Quartel, M.D., FFPM, as Chief Medical Officer, leveraging his 25 years of experience in launching enzyme replacement therapies for rare diseases. The hire comes at a critical time as Spruce prepares for a BLA filing of its lead candidate TA-ERT for Sanfilippo Syndrome Type B in Q4 2026. As an inducement award, Dr. Quartel was granted 13,000 RSUs, vesting over four years.

•3mo ago

Spruce Biosciences Joins the Russell 3000® Index

Spruce Biosciences was added to the Russell 3000® Index effective today, automatically qualifying it for inclusion in the small-cap Russell 2000® Index as part of the annual reconstitution. Management believes index inclusion will enhance visibility among institutional investors, broaden the shareholder base, and support trading liquidity. The company is advancing toward a planned Biologics License Application (BLA) submission for TA-ERT, its lead therapy candidate for Sanfilippo Syndrome Type B (MPS IIIB).

•4mo ago

Spruce Biosciences Appoints Agnieszka Jurecka, M.D., Ph.D., MPH, as Vice President, Medical Affairs

Spruce Biosciences appointed Dr. Agnieszka Jurecka as Vice President of Medical Affairs to lead medical affairs and scientific engagement ahead of a potential U.S. FDA approval for TA-ERT. Dr. Jurecka brings over 20 years of experience in rare diseases and enzyme replacement therapies, having held leadership roles at Ultragenyx, BioMarin, and CoA Therapeutics. As an inducement for her employment, she was granted restricted stock units for 3,800 shares of common stock, vesting over four years.

•4mo ago

Spruce Biosciences Appoints Eric Jordan as Vice President, Marketing and Tina Gullotta as Vice President, Finance and Corporate Controller

Spruce Biosciences appointed Eric Jordan as VP of Marketing and Tina Gullotta as VP of Finance and Corporate Controller to strengthen its commercial and financial infrastructure. The hires are timed to prepare for the potential U.S. FDA approval and commercial launch of TA-ERT, the company’s lead therapy for Sanfilippo Syndrome Type B. Both executives received inducement grants of 3,500 restricted stock units each, vesting over four years, signaling a transition toward commercial-stage operations.

•4mo ago

Spruce Biosciences Announces Long-Term Tralesinidase Alfa Enzyme Replacement Therapy Data in Sanfilippo Syndrome Type B (MPS IIIB) Presented at the 18th International MPS Symposium

Spruce Biosciences presented long-term clinical data for its lead asset, tralesinidase alfa (TA-ERT), at the 18th International MPS Symposium. The data, covering 22 patients over six years, showed that TA-ERT stabilized cognitive, communication, and motor skills relative to the decline seen in untreated natural history patients. The therapy also rapidly normalized CSF heparan sulfate levels, a surrogate endpoint for clinical benefit, while maintaining a consistent safety profile across approximately 6,000 doses.

•4mo ago

Spruce Biosciences Announces Data Presentation at the 18th International MPS Symposium

Spruce Biosciences will present long-term clinical data for its lead asset, tralesinidase alfa (TA-ERT), at the 18th International MPS Symposium in Florence, Italy. The presentation, led by Dr. Nicole Muschol, reports that long-term administration of TA-ERT results in profound and durable reduction of heparan sulfate and stabilization of cognitive function and cortical gray matter volume in patients with Sanfilippo Syndrome Type B. TA-ERT is in late-stage development for this devastating pediatric neurodegenerative disorder, for which there are currently no FDA-approved therapies, and holds multiple FDA designations including Breakthrough Therapy and Orphan Drug.

•5mo ago

Spruce Biosciences Reports First Quarter 2026 Financial Results and Provides Corporate Updates

Spruce Biosciences reported Q1 financial results, highlighting a strengthened balance sheet with $69.0 million in gross proceeds from a recent public offering and a $50.0 million term loan facility with Avenue Capital. The company stated its cash runway now extends into the second half of 2027, supporting operations through the planned BLA submission for TA-ERT in Q4 2026 and potential U.S. commercial launch in 2027. Strategic hires were made across commercial, clinical, and regulatory functions, while Q1 net loss was $12.3 million, or $(8.94) per share, compared to a net loss of $14.0 million in the prior year period.

•5mo ago

Spruce Biosciences Further Strengthens its Commercial Leadership Team with the Appointments of Brian Walls as Vice President, Market Access and Darren Johnson as Vice President, Commercial Operations

Spruce Biosciences appointed Brian Walls as Vice President of Market Access and Darren Johnson as Vice President of Commercial Operations to strengthen its commercial leadership team. Both executives bring significant experience from roles at Applied Therapeutics and Reata Pharmaceuticals, where they contributed to rare disease product launches. The strategic hires are intended to build the commercial foundation for the potential launch of TA-ERT for Sanfilippo Syndrome Type B next year.

•5mo ago