Bicara Therapeutics

BCAX

Market cap $918M

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.

BOSTON, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced that Claire Mazumdar, PhD, MBA, Chief Executive Officer, will present at the J.P. Morgan 2026 Healthcare Conference on Monday, January 12, 2026 at 11:15 a.m. PT.

Ficerafusp alfa 750mg QW in combination with pembrolizumab demonstrates consistent overall response rate and safety profile comparable to 1500mg QW dose, further derisking pivotal FORTIFI-HN01 study interim analysis

Ficerafusp alfa 750mg QW in combination with pembrolizumab demonstrates overall response rate and safety profile consistent with the 1500mg QW dose Data inform and advance progress toward dose selection for ongoing pivotal FORTIFI-HN01 clinical trial of ficerafusp alfa in combination with pembrolizumab in 1L HPV-negative R/M HNSCC Company to host conference call and webcast on Saturday, December 6, 2025 at 9:00 a.m. ET BOSTON, Dec. 01, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced the publication of an abstract with early data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa weekly (QW) in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

Bicara Therapeutics (BCAX) is initiated with a Buy rating, driven by promising data for its HNSCC candidate, Ficera. Ficera's Phase 1b results in HPV-negative HNSCC show strong efficacy, outperforming current standards, albeit rival Merus' petosemtamab data is arguably stronger. BCAX benefits from FDA Breakthrough Therapy Designation, robust cash reserves, and potential for blockbuster revenues if successful.

Granted FDA Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab in 1L HPV-negative R/M HNSCC Data from a Phase 1b expansion cohort evaluating 750mg of ficerafusp alfa weekly in combination with pembrolizumab in 1L HPV-negative R/M HNSCC patients expected at ESMO Asia 2025 Strong financial position with approximately $408 million in cash, cash equivalents, and investments as of September 30, 2025 BOSTON, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX) today announced financial results for the third quarter ended September 30, 2025 and provided a business update. “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.

Designation supported by results from multiple dose cohorts from the Phase 1/1b trial of ficerafusp alfa in 1L HPV-negative R/M HNSCC Designation supported by results from multiple dose cohorts from the Phase 1/1b trial of ficerafusp alfa in 1L HPV-negative R/M HNSCC

BOSTON, Aug. 27, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced that management will participate in multiple upcoming investor conferences:

The consensus price target hints at an 187.7% upside potential for Bicara Therapeutics Inc. (BCAX). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

Updated data from Phase 1/1b trial presented at 2025 ASCO Annual Meeting demonstrated deep and durable responses in 1L HPV-negative R/M HNSCC