During Thursday’s extended session, Fusion Pharmaceuticals Inc. (NASDAQ: FUSN) had a 7.94% increase in stock price, closing at $9.11. That carried over the regular session’s 6.84% rise to close at $8.44. With the company’s announcement of clinical programs and sharing of production information the previous day, the spike in FUSN shares persisted.
Fusion Pharmaceuticals (FUSN) reported substantial advancements with its FPI-2265 research program and the first clinical doses produced at its own manufacturing facility. FUSN is off to a strong start in 2024 with a promising registration-enabling path for FPI-2265 and positive program outcomes for FPI-1434.
In addition to the early signs of anticancer activity, a fully operational TAT manufacturing facility has begun producing clinical doses for the actinium-based PSMA lead study. FUSN successfully synchronized a protocol and development plan for FPI-2265 with the Food and Drug Administration (FDA) of the United States.
If authorized, it would give the FUSN team a possible route to registration and place FPI-2265 as the first actinium-based PSMA targeting radioligand treatment on the market. Patients who progress on or after lutetium-based therapy will likely have a major unmet need that FPI-2265 will likely address given the rapidly expanding market for PLUVICTO.
The revised development strategy calls for the completion of enrollment in a Phase 2 dosage optimization lead-in by the end of 2024, as well as the start of a Phase 3 registrational study in 2025. It is anticipated that the Phase 2 study will begin in 2024’s second quarter and that enrollment will be finished by the end of the year.
In order to ascertain the suggested Phase 3 dosage schedule based on examination of the Phase 2 data, the Company will attempt to schedule an End of Phase 2 meeting with the FDA. FUSN also manufactured the first clinical dosage of a TAT and finished validating its cutting edge good manufacturing practice (GMP) production facility.
Fusion’s facility, which can manufacture TATs on a clinical and commercial scale, is intended to support the company’s expanding TAT pipeline and has the capacity to produce up to 100,000 doses annually.