Mark Cuban’s Cost Plus Drugs to Manufacture Personalized Rare Disease Treatments

Mark Cuban’s Cost Plus Drug Company is expanding its disruption of the pharmaceutical market. The Dallas-based manufacturer is now the site of reported test cases for “n-of-1” therapies—highly personalized treatments designed for individual patients with ultra-rare diseases—potentially shifting its focus from mass-producing low-cost generics to addressing some of the most expensive medicines in the world.

Individualized treatments, often involving custom-engineered DNA-like molecules, currently carry price tags ranging from $500,000 to several million dollars per dose. By applying the “cost-plus” model—which adds a fixed 15% markup to the cost of production—Cuban aims to lower the financial barriers for families and researchers dealing with rare genetic conditions.

The company’s 22,000-square-foot Dallas facility is central to this pivot. Designed for flexibility, the plant features automated robotic filling lines capable of switching between different drug formulations in as little as four hours. This technical agility is critical for n-of-1 therapies, where production runs may only consist of enough medicine for a single patient.

The Dallas facility uses automated lines that can switch between different drug formulations in four hours.

Manufacturing “N-of-1” Molecules

According to reports from Matrix News, the two test cases at the Dallas factory include a treatment for a single patient’s neuron mutation and a muscle-control therapy developed with Dutch researchers.

Aligning with Federal Frameworks

The interest in rare diseases coincides with a significant shift in federal oversight. On October 14, 2026, the FDA launched its Rare Disease Framework Initiative, which is intended to create a “fit-for-purpose” regulatory environment for drug development. This initiative, alongside the “Plausible Mechanism Pathway,” is designed to expedite the approval of therapies that are tailored to specific genetic profiles rather than broad populations.

While the Dallas facility was originally conceived to address generic drug shortages, its potential role in personalized medicine reflects a growing trend toward “distributed manufacturing.” Instead of relying on a few massive plants to produce millions of doses, the industry is seeing a rise in smaller, high-tech facilities capable of localized, precision manufacturing. For Cuban’s company, the goal is to see if the same transparency that lowered the price of generic heart medication can be applied to the cutting edge of genomic medicine.

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