NextCure, Inc. (NXTC), Tuesday announced that the U.S. Food And Drug Administration has granted Fast Track Designation for SIM0505, an investigational antibody drug conjugate, for the treatment of platinum-resistant ovarian cancer.
The company said that the designation reflects the urgent, unmet need for new treatments for platinum resistant ovarian cancer. Also, it believes the designation would help to streamline and de-risk development through proactive and ongoing engagement with FDA.
Following this, NextCure plans to initiate dose optimization in ovarian cancer patients in the second quarter of 2026.
Also, the clinical-stage biopharmaceutical company will present Phase 1 data on the program at the upcoming 2026 American Society of Clinical Oncology conference.
In the pre-market hours, NXTC is trading at $11.70, up 6.07 percent on the Nasdaq.
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