Montana Breaks Rank: A Bold New Path for Longevity Therapies

With FDA Delays Sidestepped, Early-Stage Biotech Could Finally Catch a Break

Montana has just passed Senate Bill 535, a law that opens the door for experimental gene and cell therapies to be offered to patients after completing only Phase I clinical trials. If signed into law, this would make Montana the first U.S. state to bypass the long-standing FDA approval process and let clinics administer cutting-edge therapies based solely on safety data.

While much of the coverage so far has focused on patient access, autonomy, and ethical tradeoffs, the deeper impact may be economic. This law could reshape how longevity biotech companies fund, test, and scale their therapies.

The Hidden Breakthrough: Financial and Clinical Breathing Room for Biotech

Developing a novel therapy, especially in longevity, is brutally expensive. Most CGT (cell and gene therapy) startups face a “valley of death” after Phase I trials, where the cost of Phase II efficacy testing becomes a massive bottleneck. Montana's new law creates a kind of regulatory release valve:

• Earlier revenue streams help these companies survive past Phase I.

• Real-world patient feedback can guide R&D and product refinement.

• Montana-only manufacturing requirements could catalyze local biotech infrastructure, and shape how and where new therapies are developed.

While the law is a major step forward, this last requirement deserves attention:

All therapies must be manufactured in Montana.

This isn’t a barrier for all, but it is a notable operational consideration. Companies relying on out-of-state CDMOs or early-stage labs will need to evaluate how — or whether, they can align with this rule. It’s something founders and investors should factor into their early planning, especially as they map out R&D and clinical timelines.

That said, it could also lay the groundwork for Montana to evolve into a serious hub for CGT manufacturing and innovation, and lead other states to follow its example.

How It Works: Montana’s Expanded Right-to-Try Framework

Montana’s new legislation builds on earlier “Right-to-Try” laws but significantly broadens their scope. Key provisions include:

• Only Phase I safety data is required.

• Clinics must be licensed and renew annually.

• Strict informed consent is mandatory.

• Therapies must be manufactured in-state.

This framework creates a regulated sandbox where patients can access frontier therapies while still receiving disclosures, oversight, and safety assurances.

Parallel Track, Not a Free-For-All

Critics warn that bypassing traditional efficacy trials could lead to exploitation or erode trust in science. But proponents argue this model ...