Fusion Pharmaceuticals Inc. (NASDAQ: FUSN) has announced significant progress in its clinical program and manufacturing updates. The company is focused on developing next-generation radiopharmaceuticals as precision medicines, and its latest developments are poised to impact the market. It's shares were trading at $7.91 after logging an after-market performance of -8%.
"We begin 2024 with strong momentum, given a potential registration-enabling path for fpi-2265, encouraging results in our fpi-1434 program, including first signs of antitumor activity, and a fully operational tat manufacturing facility that has already begun to produce clinical doses for our actinium-based psma lead program," said Chief Executive Officer John Valliant, Ph.D.
Fusion Pharmaceuticals has achieved alignment with the U.S. Food and Drug Administration (FDA) on a protocol and development plan for fpi-2265, positioning it to be the first actinium-based psma targeting radioligand therapy to market, if approved.
The company also announced progress with its fpi-2265 development program, including updates on its phase 2/3 registrational program for patients with metastatic castration-resistant prostate cancer (mCRPC). Fusion Pharmaceuticals plans to initiate the phase 2 trial in the second quarter of 2024 with enrollment completed by year-end.
"We believe evaluating dosing regimens that deliver the same total dose over the same duration of treatment in the phase 2 portion of the study allows us to optimize our phase 3 clinical trial dose in alignment with FDA guidance and determine the best potential regimen of fpi-2265," said Chief Medical Officer, Dmitri Bobilev, M.D.
Additionally, Fusion Pharmaceuticals announced encouraging early findings from cohort 2 in the ongoing fpi-1434 phase 1 clinical trial, indicating a promising safety profile and early evidence of antitumor activity at the 25 kbq/kg dose level.
The company's state-of-the-art manufacturing facility is now fully operational, with the production of the first clinical doses at the company's proprietary manufacturing facility.
On a pro forma basis as of September 30, 2023, Fusion Pharmaceuticals had approximately $287 million in cash, cash equivalents, and investments, with sufficient funds to support operating expenses and capital expenditure requirements into the fourth quarter of 2025.
Fusion Pharmaceuticals is a clinical-stage oncology company with a focus on developing next-generation radiopharmaceuticals as precision medicines. Its clinical portfolio includes various targeting molecules, and the company has collaborations with AstraZeneca and Merck to jointly develop novel targeted alpha therapies and combination programs.
The company's full 8-K submission is available here.
