Welcome to our dedicated page for Bicara Therapeutics news (Ticker: BCAX), a resource for investors and traders seeking the latest updates and insights on Bicara Therapeutics stock.
Bicara Therapeutics Inc. (NASDAQ: BCAX) is a clinical-stage biopharmaceutical company whose news flow centers on the development of its lead bifunctional antibody, ficerafusp alfa, for solid tumors. Company announcements frequently highlight progress in recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC), particularly HPV-negative disease, and provide updates on related clinical trials and regulatory interactions.
Recent news has included updates on the pivotal Phase 2/3 FORTIFI-HN01 trial of ficerafusp alfa in combination with pembrolizumab in first-line HPV-negative R/M HNSCC, preliminary and expanded Phase 1/1b cohort data, and the selection of dosing strategies intended to inform the pivotal study. Bicara has also reported that the U.S. Food and Drug Administration granted Breakthrough Therapy Designation for ficerafusp alfa in combination with pembrolizumab in a defined subset of R/M HNSCC patients, and has used press releases to discuss how clinical data supported this designation.
In addition to clinical milestones, BCAX news items cover quarterly financial results, research and development spending, and cash and investment balances, reflecting the company’s status as a clinical-stage public issuer. Bicara also issues releases about participation in major medical and investor conferences, such as oncology congresses and healthcare investment events, where it presents clinical data or engages with the investment community.
Investors and observers following BCAX news can expect updates on FORTIFI-HN01 enrollment and interim analyses, data readouts from Phase 1/1b expansion cohorts in head and neck cancer and metastatic colorectal cancer, regulatory designations and guidance, and broader corporate developments. This news page aggregates those disclosures to help readers track the evolving clinical and corporate narrative around ficerafusp alfa and Bicara’s broader solid tumor strategy.
Bicara Therapeutics (Nasdaq: BCAX) announced on February 5, 2026 that it granted inducement awards under its 2026 Inducement Plan to two new employees.
The company granted non-qualified stock options to purchase 158,900 shares at an exercise price of $16.76 per share (closing price on February 2, 2026). Awards vest 25% after one year then quarterly over three years and were approved by the compensation committee under Nasdaq Listing Rule 5635(c)(4).
Bicara Therapeutics (NASDAQ: BCAX) selected 1500 mg weekly ficerafusp alfa (with pembrolizumab) as the optimal Phase 3 dose for the FORTIFI-HN01 pivotal trial in 1L HPV-negative R/M HNSCC.
The company expects substantial enrollment by end-2026 to enable an interim analysis in mid-2027 supporting a potential accelerated filing. Bicara also plans multiple expansion-cohort readouts in 2026, including Phase 1b data on 2000 mg every-other-week dosing in Q1 2026 and mCRC cohort results in H2 2026. Management will present at the J.P. Morgan Healthcare Conference on Jan 12, 2026.
Bicara Therapeutics (Nasdaq: BCAX) 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.
A live webcast will be accessible via the company’s Investor Relations website under Events and Presentations, and a replay will be archived and available after the event.
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.
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