Spruce Biosciences Fortifies Leadership for Pivotal FDA Drug Submission

SOUTH SAN FRANCISCO, Calif. – February 03, 2026 – Spruce Biosciences (Nasdaq: SPRB) has made a significant move to strengthen its executive team, signaling a clear focus on its most critical upcoming milestone: securing regulatory approval for its lead drug candidate. The late-stage biopharmaceutical company announced the strategic appointments of two seasoned industry veterans, Daven Mody, Pharm.D., and Bruno Gagnon, B.Pharm., M.Sc., to senior vice president roles.

The hires come at a pivotal moment for Spruce as it prepares to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tralesinidase alfa (TA-ERT), a novel therapy for the rare and devastating neurological disorder Sanfilippo Syndrome Type B (MPS IIIB). Mody will lead Regulatory and Quality, while Gagnon will helm Clinical Development Operations, creating a powerhouse duo designed to navigate the complex final stages of drug development and commercialization.

Assembling a Veteran Team for a High-Stakes Push

Spruce is positioning itself for a transformative period, and these appointments are a direct reflection of that strategy. The company is banking on the deep expertise of its new leaders to guide TA-ERT through the rigorous FDA review process and execute a planned confirmatory clinical trial.

“We are delighted to welcome both Daven and Bruno to the executive leadership team during a transformative time for Spruce,” said Javier Scwarzberg, M.D., M.P.H., Chief Executive Officer of Spruce Biosciences, in a statement. He emphasized that Mody’s regulatory prowess will be “instrumental” in preparing the BLA submission, while Gagnon’s global leadership in rare disease drug development will “drive the successful clinical execution” of future studies.

Mody’s role will be to orchestrate the complex BLA submission, a massive dossier of data that must convince regulators of the drug's safety and efficacy. Gagnon’s team will be responsible for running the confirmatory Phase 3 trial required by the FDA as a condition of the accelerated approval pathway Spruce is pursuing. Their complementary expertise addresses the two most critical operational fronts for the company in the coming months.

A Glimmer of Hope for Sanfilippo Syndrome

The urgency behind Spruce's mission is rooted in the brutal reality of Sanfilippo Syndrome Type B. This inherited metabolic disorder prevents the body from breaking down large sugar molecules called heparan sulfate. The resulting buildup in the brain and other organs leads to catastrophic and progressive neurodegeneration. Often called a “childhood Alzheimer's,” MPS IIIB causes severe developmental delays, cognitive decline, and behavioral issues, with a life expectancy that rarely extends beyond the late teens. Currently, there are no FDA-approved treatments, leaving families with only palliative care options.

TA-ERT is an enzyme replacement therapy designed to address the root cause of the disease. It delivers a recombinant version of the missing NAGLU enzyme directly to the cerebrospinal fluid, allowing it to enter the brain and break down the toxic accumulation of heparan sulfate.

Long-term clinical data has been promising. Spruce has reported that over five years of treatment, TA-ERT has been shown to durably normalize levels of a key disease biomarker in the cerebrospinal fluid. More importantly, this biochemical correction has been associated with sustained stabilization of brain volume and cognitive function in treated children, a stark contrast to the rapid decline seen in the natural history of the disease. The therapy's potential has earned it a slate of special regulatory designations, including Breakthrough Therapy, Fast Track, and Rare Pediatric Disease from the FDA, all of which are intended to expedite the review of drugs for serious conditions with high unmet need.

Proven Track Records in a Competitive Field

To secure these new leaders, Spruce Biosciences offered inducement awards of 5,500 restricted stock units (RSUs) to each, a common practice in the competitive biotech industry to attract top-tier talent. The track records of Mody and Gagnon demonstrate why they are considered such valuable additions.

Daven Mody brings over 25 years of regulatory affairs experience, a career defined by successfully guiding drugs to market. As Head of Regulatory Affairs at Theravance Biopharma and Impax Laboratories, he was a key figure in the first-round approvals of YUPELRI® for COPD and RYTARY® for Parkinson’s Disease, respectively. His resume includes leadership roles at industry giants like Genentech and Johnson & Johnson, giving him a comprehensive understanding of the global regulatory landscape.

Bruno Gagnon arrives with more than three decades of experience leading global clinical operations, with a particular focus on rare diseases. His background is exceptionally relevant to Spruce's current mission. During his time as Vice President of Clinical Operations at BioMarin, he directed clinical programs for rare diseases, including MPS diseases. This is especially notable as TA-ERT was originally developed by BioMarin (as BMN 250) before being acquired by Spruce. More recently, at Eidos Therapeutics, a BridgeBio Pharma affiliate, Gagnon played a key role in advancing ATTRUBY® (Acoramidis) toward regulatory approval, demonstrating his ability to manage late-stage programs through to the finish line.

Navigating a Complex Market

For a late-stage company like Spruce, which is not yet profitable, making such high-caliber hires is a significant strategic investment that has been noted by the market. The company's stock (SPRB) has reacted positively to key milestones, including hitting a 52-week high after receiving the Breakthrough Therapy Designation for TA-ERT. While analyst ratings are mixed, a consensus price target well above the current trading price suggests cautious optimism about the company’s prospects, further bolstered by a recent infusion of up to $50 million in growth capital.

While Spruce appears to be a front-runner with a BLA submission planned for the first half of 2026, it is not the only company targeting Sanfilippo Syndrome. The competitive landscape includes companies like Abeona Therapeutics and JCR Pharmaceuticals, which are exploring gene therapies and other enzyme replacement approaches. However, with five years of integrated safety and efficacy data and multiple expedited regulatory designations, TA-ERT is arguably one of the most advanced candidates for MPS IIIB.

With the appointments of Mody and Gagnon, Spruce Biosciences has strategically placed two of the industry's most experienced navigators at the helm. The focus now shifts from discovery to execution. As the company advances toward its BLA submission, all eyes will be on this newly fortified leadership team to guide a potential first-in-class therapy across the finish line for a patient community that has waited far too long.