Spruce Biosciences is welcoming two new leaders, both named to Senior Vice President (SVP) posts. Daven Mody, PharmD, will be SVP of Regulatory and Quality. Bruno Gagnon, BPharm, MSc, will be SVP of Clinical Development Operations.

Spruce Bio CEO Javier Scwarzberg, MD, MPH, said the company was “delighted” to welcome both during a “transformative time.”

SVP Backgrounds and Expertise

Mody is the founder of AZURA Life Sciences, a regulatory and quality consultancy. He served in similar posts to his new one at Spruce Bio with Lassen Therapeutics, Ocelot Bio, and Blade Therapeutics.

At those companies, Mody was team lead on investigational programs for ophthalmologic, hepatic, pulmonary, and oncology indications.

Mody’s resume also includes Theravance Biopharma, Impax Laboratories, ALZA Corporation, Matrix Pharmaceuticals, Genentech, CoTherix, Johnson & Johnson, and Medivation.

Currently, Spruce Bio seeks a Biologics License Application and FDA approval for its tralesinidase alfa enzyme replacement therapy (TA-ERT) program. This is for the treatment of Sanfillipo syndrome type B (MPS IIIB).

“Daven’s regulatory expertise is unparalleled across the industry,” Scwarzberg said. “His significant experience from successful filings and approvals of multiple NDAs and MAAs will be instrumental.”

Meanwhile, Gagnon was previously SVP of Global Clinical Operations at Opthea. There, he oversaw clinical execution of a Phase III wet age-related macular degeneration program.

Gagnon has also led development operations for Eidos Therapeutics, a BridgeBio Pharma affiliate, overseeing a transthyretin (TTR) amyloidosis program. Additionally, he served as Vice President of Clinical Operations at BioMarin.

Spruce Biosciences Makes Forward Moves

Scwarzberg said Gagnon’s addition is imperative, as Spruce Bio plans a confirmatory study of TA-ERT and other pipeline programs.

“Bruno’s global leadership experience in rare disease drug development, including in MPS diseases, will drive … successful clinical execution,” Scwarzberg said.

Previously in 2026, Harbour BioMed announced the exercising of a warrant agreement with Spruce Bio. Under its terms, Harbour acquired common stock in Spruce, now holding approximately 3.8% of Spruce’s total outstanding shares.