secwatch.observer — SEC 8-K summary
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Issuer:     Bicara Therapeutics Inc. (BCAX)
CIK:        0002023658
Form:       8-K
Filed at:   2026-01-12T23:59:59+00:00
Accession:  0001628280-26-001766
Event type: other_material
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Bicara selects 1500 mg ficerafusp alfa dose for Phase 3 pivotal HNSCC study
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- Selected 1500 mg QW ficerafusp alfa plus pembrolizumab as optimal dose for Phase 3 FORTIFI-HN01 in 1L HPV-negative R/M HNSCC.
- Expects substantial enrollment by end-2026 to enable interim analysis mid-2027 for potential accelerated filing.
- Plans to present Phase 1b expansion data in 1L HNSCC (Q1 2026) and long-term follow-up (Q2 2026).
- Will explore ficerafusp alfa in other solid tumors; Phase 1b mCRC data expected H2 2026.
- Planning critical commercial hires in 2026, including Chief Commercial Officer, to prepare for launch.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/2023658/000162828026001766/0001628280-26-001766-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/2023658/000162828026001766/bcax-20260112.htm
  HTML page:      https://secwatch.observer/filing/0001628280-26-001766

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