CUE - Cue Biopharma shares rise ~10% on FDA fast track nod for head and neck cancer drug

• Cue Biopharma ( NASDAQ: CUE ) on Tuesday said it had got a fast track designation from the U.S. FDA for its drug candidate CUE-101 for the treatment of head and neck cancer associated with human papilloma virus.
• CUE stock jumped 9.6% to $2.62 in early trading.
• The designation was for CUE-101 as a monotherapy and in combination with Merck's ( MRK ) Keytruda for the treatment of human papilloma virus recurrent/metastatic head and neck squamous cell carcinoma.
• The FDA's Fast Track approval is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
• "To date in its Phase 1b clinical trials, CUE-101 has demonstrated a favorable tolerability profile and single-agent anti-tumor activity in monotherapy as well as encouraging anti-tumor clinical activity in combination with (Keytruda)," CUE senior vice president of clinical development Matteo Levisetti said in a statement .

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