Oct. 13 at 2:09 PM
Shares of Bicara Therapeutics Inc. rose in premarket trading Monday after the company said its cancer therapy ficerafusp alfa received Breakthrough Therapy Designation (BTD) from the FDA.
The BTD covers ficerafusp alfa combined with pembrolizumab as a first-line treatment for metastatic or unresectable recurrent head and neck squamous cell carcinoma expressing PD-L1, excluding HPV-positive cases.
The decision was based on Phase 1/1b data showing a median response duration of 21.7 months and overall survival of 21.3 months, with a favorable safety profile, presented at the 2025 ASCO Annual Meeting.
CEO Claire Mazumdar said the designation validates ficerafusp alfa’s best-in-class potential and supports the ongoing FORTIFI-HN01 pivotal trial.
The FDA’s BTD aims to accelerate development and review of drugs showing substantial improvement over existing therapies.
$BCAX