Bicara Therapeutics Stock Price, News & Analysis

Bicara Therapeutics (Nasdaq: BCAX) presented preliminary Phase 1b expansion data for ficerafusp alfa 750mg QW plus pembrolizumab in 1L HPV-negative R/M HNSCC on Dec 6, 2025.

Key metrics: 57% confirmed overall response rate, 10% complete responses, and 29% of responders with ≥80% tumor shrinkage at preliminary follow-up. Biomarker comparisons show 1500mg yields greater intratumoral TGF-β inhibition, higher immune activation, and deeper responses (median depth 82% vs 63%). Company expects to declare the pivotal FORTIFI-HN01 optimal dose in Q1 2026.

Bicara Therapeutics (NASDAQ: BCAX) reported preliminary Phase 1b expansion cohort data evaluating 750 mg weekly ficerafusp alfa plus pembrolizumab in first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (1L HPV-negative R/M HNSCC).

Key readouts (July 9, 2025 cutoff) in the efficacy-evaluable population (n=30): 57% objective response rate (17/30; 15 PR, 2 CR) and 83% disease control rate (25/30). Complete, prolonged neutralization of TGF-β1 was observed and safety was consistent with the known profile. Data inform dose selection for the pivotal FORTIFI-HN01 trial and supported the company’s FDA Breakthrough Therapy Designation. Results will be presented at ESMO Asia 2025 with a company webcast and conference call on Dec 6, 2025 at 9:00 a.m. ET.

Bicara Therapeutics (NASDAQ: BCAX) reported Q3 2025 results and a business update on Nov 10, 2025. The FDA granted Breakthrough Therapy Designation for ficerafusp alfa plus pembrolizumab in 1L HPV-negative R/M HNSCC. The company continues to enroll the pivotal Phase 2/3 FORTIFI-HN01 trial and plans multiple Phase 1b data presentations, including a 750mg cohort at ESMO Asia 2025. Financials: $407.6M cash, cash equivalents and investments as of Sept 30, 2025; cash expected to fund operations into H1 2029. Q3 operating spend included R&D $33.0M and G&A $7.7M; net loss $36.3M.

Bicara Therapeutics (Nasdaq: BCAX) announced the U.S. FDA granted Breakthrough Therapy Designation to ficerafusp alfa plus pembrolizumab for first-line treatment of metastatic or unresectable, recurrent HPV-negative HNSCC with PD-L1 CPS ≥1 (excluding HPV-positive oropharyngeal SCC) on Oct 13, 2025.

BTD was supported by Phase 1/1b cohorts presented at ASCO 2025 showing a median duration of response 21.7 months and median overall survival 21.3 months with a favorable safety profile. The designation enables increased FDA interaction, senior leadership involvement, and eligibility for rolling and priority review and supports the ongoing pivotal FORTIFI-HN01 trial.

Bicara Therapeutics (Nasdaq: BCAX), a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, has announced its participation in three major upcoming healthcare investor conferences in September 2025.

The company will present at the Cantor Global Healthcare Conference (September 3, 10:55 a.m. ET), the Wells Fargo Healthcare Conference (September 3, 2:15 p.m. ET), and the Morgan Stanley Global Healthcare Conference (September 8, 4:05 p.m. ET). All fireside chat presentations will be available via webcast through Bicara's Investor Relations website.

Bicara Therapeutics (NASDAQ:BCAX) reported Q2 2025 financial results and provided updates on its lead drug candidate ficerafusp alfa. The company highlighted strong Phase 1/1b trial results presented at ASCO 2025, showing a 54% confirmed objective response rate in HPV-negative head and neck cancer patients, with median duration of response of 21.7 months.

The company maintains a robust financial position with $436.6 million in cash, expected to fund operations into H1 2029. Q2 2025 saw increased R&D expenses of $24.8 million and a net loss of $27.4 million. The ongoing pivotal Phase 2/3 FORTIFI-HN01 trial continues enrollment, with additional Phase 1/1b expansion cohort data expected by Q1 2026.

Rice Biotech Launch Pad has appointed Carolyn Ng, a business unit partner at TPG Life Sciences Innovations, to its external advisory board. Ng brings significant expertise in biotech and company building, with extensive experience guiding early to midstage companies across various therapeutic areas.

Currently leading investments at TPG Life Sciences Innovations in San Francisco, Ng serves on multiple boards including Mbrace Therapeutics, Adcendo Aps, and Bicara Therapeutics (NASDAQ: BCAX). Her appointment marks her as the 16th member of the Launch Pad's external advisory board, joining leaders from various prestigious institutions and companies.

The Rice Biotech Launch Pad, based in Houston, focuses on accelerating the translation of Rice University's health and medical technology discoveries into practical medical solutions.

Bicara Therapeutics (Nasdaq: BCAX), a clinical-stage biopharmaceutical company focused on developing bifunctional therapies for solid tumors, announced its upcoming participation in the Goldman Sachs 46th Annual Global Healthcare Conference. The company's management team will engage in a fireside chat scheduled for Tuesday, June 10, 2025, at 3:20 p.m. ET. Investors and interested parties can access the live presentation through the Events and Presentations section of Bicara's Investor Relations website. A recording of the webcast will be made available for later viewing on the company's website.

Bicara Therapeutics (NASDAQ: BCAX) presented promising Phase 1/1b trial results for ficerafusp alfa combined with pembrolizumab in first-line recurrent/metastatic HPV-negative head and neck cancer at ASCO 2025. The trial demonstrated impressive efficacy with a median duration of response of 21.7 months and 80% of responders achieving deep responses (≥80% tumor shrinkage). Key results include a 54% confirmed objective response rate, 21% complete response rate, median overall survival of 21.3 months, and a 2-year overall survival rate of 46%. The drug, a first-in-class bifunctional antibody targeting EGFR and TGF-β, showed a manageable safety profile. These results support the advancement of FORTIFI-HN01, the company's pivotal Phase 2/3 trial in first-line recurrent/metastatic setting.