Bicara Therapeutics reports Q3 EPS (67c), consensus (53c)

“The FDA’s recent Breakthrough Therapy Designation for ficerafusp alfa in first-line HPV-negative HNSCC represents an important milestone for Bicara and validates the strength of our clinical data and our development plan, specifically underscoring the growing recognition of HPV-negative disease as a distinct clinical indication within HNSCC,” said Claire Mazumdar, PhD, MBA, Chief Executive Officer of Bicara Therapeutics (BCAX). “As we head into 2026, our focus continues to be on executing the enrollment of our pivotal Phase 2/3 FORTIFI-HN01 trial in first-line HPV-negative HNSCC and presenting additional data for ficerafusp alfa across dose cohorts to further characterize its tolerability and efficacy profile and inform the dose selection for our pivotal FORTIFI-HN01 study. Ficerafusp alfa is the first and only bifunctional antibody that uses an EGFR antibody backbone to localize TGF-beta inhibition to increase tumor penetration and drive deep and durable responses across tumor types. We are encouraged by the evolving base of evidence that continues to demonstrate the potential of ficerafusp alfa and targeted TGF-beta inhibition in HNSCC and other tumors.”