Shares of Fusion Pharmaceuticals rose in post-market trading on Thursday after the company had a study protocol approved by regulators.
The stock was up 7.8% to $9.10, after it closed the market session up 6.8%. Shares have more than doubled in the last three months.
The company, which is focused on the development of oncology drugs, said it had aligned with the Food and Drug Administration on its Phase 2/3 protocol for FPI-2265, a treatment for certain kinds of prostate cancer. The updated development plan includes a Phase 2 dose optimization lead-in and a Phase 3 registrational trial, which is expected to begin in 2025.
The treatment is a targeted alpha therapy that will be evaluated for use in patients with metastatic castration-resistant prostate cancer with progressive disease.
Chief Executive John Valliant said the plan outlined a path for bringing the therapy to market, if approved.
Fusion said it had also produced its first clinical dose at its proprietary manufacturing facility.