Aktis Oncology, Inc. (AKTS), Tuesday announced that the U.S. Food and Drug Administration has granted Fast Track designation to AKY-1189 for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
The company stated that the designation would help it to work closely with the FDA to potentially expedite the development and review process of AKY-1189 with the goal of bringing a new therapeutic option to patients with locally advanced or metastatic urothelial cancer.
Aktis is currently conducting a multi-site Phase 1b clinical trial of AKY-1189 for the treatment of locally advanced or mUC, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer.
It expects to present preliminary results from Part 1 of the trial in the first quarter of 2027.
In the pre-market hours, AKTS is trading at $19.75, up 1.65 percent on the Nasdaq.
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