Tolmar deal sets U.S. path for Alpha DaRT in prostate cancer

Alpha Tau Medical and Tolmar International have signed collaboration and supply agreements covering development and U.S. commercialization of Alpha DaRT for prostate cancer.

Tolmar will hold exclusive U.S. commercialization rights for Alpha DaRT in prostate cancer for a term expected to run 20 years from first commercial sale, subject to the collaboration agreement.

Alpha Tau will lead clinical development and will remain responsible for manufacturing and product supply. Tolmar will control U.S. commercialization, including pricing, customer engagement, and sales execution.

At closing, Tolmar will make a $20M equity investment in Alpha Tau at $11.99 per share and pay $15M toward construction of a new Alpha DaRT production facility in the U.S.

The agreement also includes up to $96.5M in development and regulatory milestone payments for the initial prostate cancer indication, plus up to $65M in commercial milestones.

Alpha Tau said the supply price to Tolmar will be based on a percentage of net sales, set at 60% and subject to adjustments defined in the supply agreement.

Tolmar also receives an option to expand the agreement into U.S. bladder cancer commercialization if specified clinical criteria are met. Exercising that option would trigger an additional $5M equity investment, $5M for expanded manufacturing capacity, and potential development and regulatory payments of up to $96.5M for the first bladder cancer indication pursued jointly.

The companies said Alpha DaRT, or Diffusing Alpha-emitters Radiation Therapy, is designed to deliver alpha radiation directly inside solid tumors through recoiling radioisotopes that release high-energy, short-range alpha particles.

Alpha Tau received FDA approval in December 2025 for an investigational device exemption application to start a U.S. pilot study of Alpha DaRT in locally recurrent prostate cancer.

The SEC filing tied to the agreement states that Alpha Tau retains all rights to Alpha DaRT outside the prostate and bladder markets in the U.S., as well as all global rights outside the U.S.