Mobility as a Service (MaaS) is a digital platform that bundles different transportation options—such as buses, trains, taxis, car-sharing and bike rentals—into a single app or subscription, letting users plan, book and pay for door-to-door trips in one place. For investors, MaaS matters because it can change how people use transport, shift revenue from vehicle sales to recurring service fees, and create new opportunities and risks for companies and cities as consumers move toward integrated, subscription-style mobility instead of owning vehicles.
u.s. fdaregulatory
The U.S. FDA is the federal agency that reviews and approves drugs, vaccines, medical devices and food products for safety and effectiveness before they can be sold in the United States. For investors, FDA actions act like a gatekeeper — approvals can open the door to large sales and higher company value, while rejections, delays or safety warnings can sharply cut a product’s market potential and a company’s revenue outlook.
enzyme replacement therapymedical
Enzyme replacement therapy is a medical treatment that involves providing patients with artificial versions of natural enzymes their bodies are missing or not producing enough of. This approach can help manage certain health conditions by restoring essential functions, similar to replacing a faulty part in a machine to keep it running smoothly. For investors, advancements or approvals in this therapy can signal progress in biotech innovation and potential market growth.
rsusfinancial
RSUs, or restricted stock units, are a form of company shares given to employees as part of their compensation. They are typically awarded with certain restrictions, such as a waiting period before they can be fully owned or sold, similar to earning a gift that becomes fully yours over time. For investors, RSUs can impact a company's stock offerings and reflect how much the company relies on stock-based incentives to attract and retain talent.
orphan drugregulatory
A drug designated for an orphan disease is a medicine developed to treat a rare condition that affects only a small number of people. Regulators often give these drugs special incentives—such as reduced costs, faster review, and temporary exclusive selling rights—to encourage development, which matters to investors because those incentives can make a small market financially viable and reduce competition, much like a temporary patent on a niche product.
fast track designationsregulatory
A fast track designation is a regulatory status granted to a drug or therapy intended to treat a serious condition with unmet medical need, which gives the developer access to expedited interactions and review procedures with regulators. For investors, it’s like an express lane: it can shorten development and review timelines and reduce regulatory uncertainty, potentially speeding a product to market—but it does not guarantee approval or commercial success.
Daven Mody, Pharm.D., Appointed as Senior Vice President, Regulatory and Quality
Bruno Gagnon, B.Pharm., M.Sc., Appointed as Senior Vice President, Clinical DevelopmentOperations
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--
Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need, today announced the appointments of Daven Mody, Pharm.D., as Senior Vice President of Regulatory and Quality and Bruno Gagnon, B.Pharm., M.Sc., as Senior Vice President, Clinical Development Operations.
“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. “Daven’s regulatory expertise is unparalleled across the industry, and his significant experience from successful filings and approvals of multiple NDAs and MAAs will be instrumental as we prepare for the BLA submission and seek potential U.S. FDA approval of our tralesinidase alfa enzyme replacement therapy (TA-ERT) program for the treatment of Sanfillipo Syndrome Type B (MPS IIIB). I believe that Bruno’s global leadership experience in rare disease drug development, including in MPS diseases, will drive the successful clinical execution of our planned confirmatory study of TA-ERT and other pipeline programs.”
Daven Mody, Pharm.D., brings over 25 years of regulatory affairs experience, guiding global development programs across multiple therapeutic areas including rare diseases. He most recently served as Senior Vice President, Regulatory Affairs and Quality at Lassen Therapeutics, Ocelot Bio, and Blade Therapeutics, working as team lead on investigational programs for multiple ophthalmologic, hepatic, pulmonary, hepatic, and oncology indications for which he helped secure several orphan drug and fast track designations. Earlier, he served as Head of Regulatory Affairs at Theravance Biopharma and Impax Laboratories where he led the efforts in the first-round approvals of YUPELRI® for COPD and RYTARY® for Parkinson’s Disease, respectively, by both the U.S. FDA and EMA. Dr. Mody began his career at ALZA Corporation and since held roles of increasing leadership responsibility within regulatory affairs at Matrix Pharmaceuticals, Genentech, CoTherix, Johnson & Johnson, and Medivation. He also founded AZURA Life Sciences, LLC, a regulatory and quality consultancy. He received a Pharm.D. from the University of the Pacific and an MBA from California State University, East Bay. Dr. Mody is certified by the Regulatory Affairs Certification Board.
Bruno Gagnon, B.Pharm., M.Sc., joins Spruce Biosciences with more than 30 years of experience leading clinical operations for global drug development programs. As Senior Vice President of Global Clinical Operations at Opthea, Mr. Gagnon oversaw clinical program execution for a Phase 3 pivotal wet age-related macular degeneration (wet AMD) program and took on interim responsibility for medical affairs and pharmacovigilance. Previously, he led development operations for BridgeBio Pharma’s affiliate, Eidos Therapeutics, where he oversaw strategic planning and operational execution of clinical trials for the company’s TTR amyloidosis program and played a key role in advancing ATTRUBY® (Acoramidis) towards regulatory approval. Earlier, he served as Vice President of Clinical Operations at BioMarin, directing rare disease clinical programs and global trial execution for six compounds across all stages of development. He earned his M.Sc. in pharmaceutical sciences and drug development from the University of Montreal and a B.S. in pharmacy from Laval University.
Inducement Awards
In connection with Dr. Mody’s and Mr. Gagnon’s employment with Spruce, on February 2, 2026 each of Dr. Mody and Mr. Gagnon were granted restricted stock units (RSUs) for 5,500 shares of Spruce’s common stock. While the inducement awards are being made outside of Spruce’s 2020 Equity Incentive Plan, the awards will be subject to terms and conditions generally consistent with those set forth under such plan and the award agreements thereunder. The Compensation Committee of the Board of Directors approved the awards as an inducement material to Dr. Mody’s and Mr. Gagnon’s entering into employment with the company in accordance with Nasdaq Listing Rule 5635(c)(4). The RSUs will be subject to time-based vesting criteria, vesting in equal annual installments over four years.
About Spruce Biosciences
Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for neurological disorders with significant unmet medical need. To learn more, visit www.sprucebio.com and follow us on X, LinkedIn, Facebook and YouTube.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the impact of new management hires, the fulfillment of Spruce’s strategic business objectives, the advancement and clinical execution of Spruce’s drug development pipeline programs, and potential U.S. FDA approval. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “plans”, “will”, “believe”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruce’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Spruce’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Spruce’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Spruce undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
