regulatory
confidence high
sentiment positive
materiality 0.70
FDA allows Galectin Therapeutics to proceed with Phase 2 trial of belapectin + Keytruda in head and neck cancer
GALECTIN THERAPEUTICS INC
- FDA issued 'Study May Proceed' letter for Phase 2 trial of belapectin + pembrolizumab as first-line therapy for recurrent/metastatic PD-L1 positive head and neck squamous cell carcinoma.
- This IND is the company's second; prior investigator-initiated study provided rationale for combination.
- Company expects to complete enrollment in pivotal NAVIGATE trial in NASH cirrhosis around end of 2022.
- Company plans to engage potential partners for oncology program; financing and trial start could occur next year.