MT SB535 1st of Its Kind Right to Try Law
Montana Senate Bill 535:
New Opportunities for Biopharma in Montana
Montana has taken a bold step to expand access to experimental treatments through the passage of Senate Bill 535 (SB535) in May 2025. This first-of-its-kind legislation builds on the state’s earlier right-to-try laws and creates an entirely new framework for licensed experimental treatment centers.
What SB535 Does
- Allows healthcare providers, through licensed treatment centers, to administer experimental treatments that have successfully completed Phase I clinical trials but are not yet fully approved by the FDA.
- Establishes a regulatory structure for experimental treatment centers, including licensing, provider eligibility, informed consent requirements, safety oversight, and reporting.
- Requires centers to dedicate 2% of annual net profits toward improving access to experimental treatments for Montana residents.
Why It Matters
SB535 makes Montana the only state in the nation where firms can move quickly from a successful Phase I trial into limited commercialization. This positions Montana as a highly attractive location for biopharma, biotherapeutics, and other life sciences companies that want to accelerate time-to-market while continuing the federal FDA approval process.
Implications for the Innovation Corridor Gateway
With SB535 in place, demand is expected to grow for high-quality facilities that can support experimental treatment activity. The planned Montana Innovation Corridor Gateway Phase One building will include a 10,000 SF GMP-ready space — a flexible shell equipped with essential infrastructure for pilot manufacturing and commercialization.
By co-locating with complementary tenants such as contract research organizations (CROs), regulatory consultants, and professional service providers, biopharma firms entering Montana under SB535 will have access to a supportive ecosystem. The presence of the Montana World Trade Center (MWTC) on-site will also ensure global connectivity and catalytic programming.
Opportunity for Bio Firms
For companies in the biopharma space, SB535 represents a unique competitive advantage available only in Montana. The Gateway project, with its GMP-ready capacity and innovation ecosystem, is designed to make it easier for firms to establish a presence, launch pilot manufacturing, and connect to global markets.