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Bicara Therapeutics Announces Phase 3 Optimal Dose and Provides 2026 Corporate Outlook
Selected 1500 mg of ficerafusp alfa as the optimal dose for the treatment of 1L HPV-negative R/M HNSCC in Phase 3 FORTIFI-HN01 pivotal study Expects to
About this update from Bicara Therapeutics Inc.
[{"type":"text","content":"Selected 1500 mg of ficerafusp alfa as the optimal dose for the treatment of 1L HPV-negative R/M HNSCC in Phase 3 FORTIFI-HN01 pivotal study Expects to achieve substantial enrollment in FORTIFI-HN01 in 2026 to enable interim analysis in mid-2027 Anticipates multiple expansion cohort data readouts in 2026 to further characterize ficerafusp alfa’s profile in HPV-negative HNSCC and support potential expansion into other solid tumor types, including colorectal cancer Claire Mazumdar, PhD, MBA, Chief Executive Officer, to present at the J.P. Morgan 2026 Healthcare Conference on Monday, January 12 at 11:15 a.m. PT (2:15 p.m. ET) BOSTON, Jan. 12, 2026 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today provided a 2026 corporate outlook and strategy for continued growth, building upon the clinical success of ficerafusp alfa, the first and only bifunctional epidermal growth factor receptor (EGFR)-directed antibody combined with a TGF-β ligand trap designed to drive increased tumor penetration and improve survival outcomes. “Bicara is entering 2026 with strong momentum and a clear plan for growth as we advance ficerafusp alfa, designed to generate significantly improved clinical outcomes in head and neck cancer that we believe will translate to commercial success,” said Claire Mazumdar, PhD, MBA, Chief Executive Officer at Bicara Therapeutics. “We are thrilled to announce that we have selected 1500 mg of ficerafusp alfa as the optimal dose for Phase 3 of the FORTIFI-HN01 pivotal study. Our focus for 2026 is to accelerate enrollment and end the year with a clear line of sight to an interim analysis in mid-2027 to support a potential accelerated filing. Our goal is to ensure that we are best positioned to achieve ficerafusp alfa’s blockbuster commercial potential, while advancing other signal-finding efforts that are based upon clear biologic and mechanistic rationale to better characterize ficerafusp alfa’s pipeline-in-a-product potential.” Selected 1500 mg QW of ficerafusp alfa in combination with pembrolizumab as the optimal dose for Phase 3 FORTIFI-HN01 pivotal study, earlier than anticipatedBicara has aligned with the U.S. Food and Drug Administration (FDA) on a clear path to implement, by...