Fusion Pharmaceuticals (NASDAQ:FUSN) has unveiled the successful completion of its latest project – the new radiopharmaceuticals manufacturing facility that is now fully operational, aiming to revolutionize the company’s production capabilities.

The state-of-the-art manufacturing facility is poised to bolster the in-house production of the company’s targeted alpha therapy products and provide on-site production of actinium-25.

The plant is anticipated to manufacture up to 100,000 doses of TATs annually, showcasing Fusion’s commitment to scaling up its operations. It has already commenced the production of doses for its actinium-based PSMA lead program.

Fusion’s update on its pipeline candidates revealed significant progress, with the company aligning with the FDA on the protocol for a Phase 2/3 study of its drug FPI-2265 for metastatic castration-resistant prostate cancer, or mCRPC. The Phase 2 study enrollment is slated for completion by the end of 2024, paving the way for a registrational Phase 3 study expected to commence in 2025.

The biotech company also plans to report data from an ongoing Phase 2 trial for FPI-2265 in mCRPC in April, and prioritize enrollment for the new Phase 2/3 study. Furthermore, it aims to initiate a combination trial of FPI-2265 and olaparib in the first half of 2024, showcasing the company’s commitment to advancing its clinical programs.

Additionally, Fusion highlighted its optimism surrounding early data from a Phase 1 study of its candidate FPI-1434, with plans to share additional details about the program in mid-2024, reflecting the company’s dedication to transparency and communication with investors.