08:30 AM EDT, 10/13/2025 (MT Newswires) -- Bicara Therapeutics ( BCAX ) said Monday that ficerafusp alfa in combination with pembrolizumab for the treatment of head and neck squamous cell carcinoma, or HNSCC, has received Breakthrough Therapy Designation from the US Food and Drug Administration.

The designation shows recognition of human papillomavirus-negative HNSCC as a clear clinical indication within head and neck cancer and is backed by results from various phase 1/1b dose groups assessing ficerafusp alfa plus pembrolizumab, the company said.

Recent data showed a median duration of response of 21.7 months, a median overall survival of 21.3 months, and a favorable safety and tolerability profile, Bicara said.

Bicara shares were up over 4% in recent premarket activity.