- Fusion Pharmaceuticals Inc FUSN acquired the investigational new drug application for an ongoing Phase 2 TATCIST trial evaluating 225Ac-PSMA I&T, a small molecule targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancers, from RadioMedix Inc.
- Following the closing, the alpha-emitting radiopharmaceutical evaluated in the TATCIST trial will be known as FPI-2265.
- The TATCIST trial is evaluating metastatic castration-resistant prostate cancer patients with progressive disease, including patients who are naïve to PSMA-targeted radiopharmaceuticals and those who have been pre-treated with 177Lu-based PSMA radiopharmaceutical.
- The trial is expected to evaluate approximately 100 patients, with four treatment cycles per patient occurring every eight weeks. Patients are initially dosed at 100 kBq/kg, with dose de-escalation possible based on biochemical response.
- Efficacy will be assessed using changes in PSA levels and radiographic response.
- Fusion plans to expand the Phase 2 program to additional sites and expects to report data on 20 to 30 patients in Q1 of 2024.
- In connection with the closing of the acquisition of the TATCIST trial and related assets, Fusion has announced a private placement of $60 million.
- Fusion will issue approximately 17.6 million shares at $3.40/share.
- The company anticipates a cash balance of $248.0 million, sufficient to fund its planned operating expenses and capital expenditure requirements into Q1 of 2025.
- Price Action: FUSN shares are up 30.70% at $4.73 during the premarket session on the last check Tuesday.
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