Bicara Therapeutics (BCAX) FDA Approvals

Bicara Therapeutics' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Bicara Therapeutics (BCAX). Over the past two years, Bicara Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ficerafusp. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Ficerafusp alfa FDA Regulatory Timeline and Events

Ficerafusp alfa is a drug developed by Bicara Therapeutics for the following indication: squamous cancer of the anal canal (SCAC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Data Presentation - February 19,2026

• Drug: ficerafusp alfa
• Announced Date: February 19, 2026
• Indication: squamous cancer of the anal canal (SCAC).

Bicara Therapeutics Inc today presented preliminary safety and efficacy data from an exploratory Phase 1b expansion cohort evaluating 2000mg of ficerafusp alfa every other week (Q2W) 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 presented preliminary Phase 1b expansion data testing 2000 mg of ficerafusp alfa every other week (Q2W) with pembrolizumab in first-line, HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The company reported rapid, deep and durable tumor responses and a generally well-tolerated safety profile. Ficerafusp alfa is a bifunctional EGFR-directed antibody combined with a TGF-β ligand trap, designed to improve tumor penetration and boost anti-tumor activity when paired with pembrolizumab.

Bicara plans to pursue a loading dose followed by an every-three-week maintenance regimen for ficerafusp alfa, pending regulatory alignment, while continuing global enrollment in the pivotal FORTIFI-HN01 program (evaluating 1500 mg weekly). The company will host a conference call and webcast on Friday, February 20, 2026 at 8:30 a.m. ET to discuss the data and next steps.

Preliminary Data - December 6,2025

Phase 1b

• Drug: ficerafusp alfa
• Announced Date: December 6, 2025
• Indication: squamous cancer of the anal canal (SCAC).

Bicara Therapeutics Inc. presented preliminary data from a Phase 1b expansion cohort evaluating 750 mg 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 presented preliminary Phase 1b data evaluating 750 mg of ficerafusp alfa given weekly with pembrolizumab in first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma. At early follow-up the combination showed a 57% confirmed overall response rate, including 10% complete responses. Among responders, 29% had deep responses (at least 80% tumor shrinkage). Treatment was generally well tolerated, with a safety profile consistent with prior experience of the combination.

Biomarker analyses comparing 750 mg and 1500 mg doses showed the higher dose produced greater TGF-β inhibition inside tumors and stronger immune activation. That translated to deeper shrinkage at 24 weeks: median depth of response was 63% at 750 mg versus 82% at 1500 mg, and 27% versus 64% of responders achieved deep responses, respectively. These findings suggest greater TGF-β inhibition may drive deeper, more durable outcomes and will inform dose selection for the pivotal FORTIFI-HN01 study, with an optimal dose decision expected in early 2026.

Publication - December 1,2025

Phase 1b

• Drug: ficerafusp alfa
• Announced Date: December 1, 2025
• Indication: squamous cancer of the anal canal (SCAC).

Bicara Therapeutics Inc. 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 announced an abstract reporting early Phase 1b data for 750 mg weekly (QW) ficerafusp alfa combined with pembrolizumab in first-line HPV-negative recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). The company said these 750 mg results are consistent with data seen at the 1500 mg QW dose and will inform dose selection for the ongoing pivotal FORTIFI-HN01 trial. The findings will be highlighted in an oral presentation at ESMO Asia and discussed on a company webcast and call on December 6, 2025.

With a July 9 cutoff, the efficacy-evaluable group (n=30) showed a 57% objective response rate (17/30), including 50% partial responses (15/30) and 7% complete responses (2/30), and an 83% disease control rate (25/30). Complete, prolonged neutralization of TGF-β1 was observed, and safety was consistent with the known profile of ficerafusp alfa plus pembrolizumab in R/M HNSCC. These early data support continued development and dose selection.

Designation Grant - October 13,2025

Breakthrough Therapy

• Drug: ficerafusp alfa
• Announced Date: October 13, 2025
• Indication: squamous cancer of the anal canal (SCAC).

Bicara Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to ficerafusp alfa in combination with pembrolizumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) head and neck squamous cell carcinoma (HNSCC) whose tumors express programmed death-ligand 1 with combined positive score (CPS) ≥1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma.

The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to ficerafusp alfa in combination with pembrolizumab for first-line treatment of patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma whose tumors express PD-L1 with a combined positive score of ≥1, excluding HPV-positive oropharyngeal cases.

This designation recognizes the critical unmet need in HPV-negative HNSCC, which carries poor outcomes and few treatment options. Dr. David Raben, Chief Medical Officer of Bicara Therapeutics, said that ficerafusp alfa’s tumor-penetrating action and synergy with pembrolizumab could deliver deeper, longer-lasting responses.

Data from Phase 1/1b studies showed a median duration of response of 21.7 months and median overall survival of 21.3 months, along with a favorable safety profile.

Breakthrough Therapy Designation will accelerate FDA interactions and reviews, bolstering the ongoing pivotal FORTIFI-HN01 trial to bring this promising combination to patients more quickly, said CEO Claire Mazumdar.

Data Presentation - June 1,2025

Phase 1/1b

• Drug: ficerafusp alfa
• Announced Date: June 1, 2025
• Indication: squamous cancer of the anal canal (SCAC).

Bicara Therapeutics Inc. presented updated data from the company's Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.

Bicara Therapeutics Inc. recently presented updated data at the 2025 ASCO Annual Meeting from its Phase 1/1b clinical trial. The study evaluates the combination of ficerafusp alfa and pembrolizumab in patients with first-line recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).

The data shows promising anti-tumor activity, with responders enjoying a median duration of response of 21.7 months. Impressively, 80% of responders achieved a deep response with at least 80% tumor shrinkage. In addition, overall survival outcomes were encouraging, with a median OS of 21.3 months and a two-year OS rate of 46% in HPV-negative patients, a group traditionally facing limited treatment benefits. These results suggest that ficerafusp alfa’s ability to improve tumor penetration may enhance the effects of pembrolizumab, supporting further development in the ongoing pivotal Phase 2/3 FORTIFI-HN01 trial.

Abstract - May 22,2025

Phase 1/1b

• Drug: ficerafusp alfa
• Announced Date: May 22, 2025
• Indication: squamous cancer of the anal canal (SCAC).

Bicara Therapeutics Inc. announced the publication of an abstract with updated interim data from the company's Phase 1/1b clinical trial of ficerafusp alfa in combination with pembrolizumab in patients with first line (1L) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) on the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting website.

Bicara Therapeutics Inc. announced the publication of an abstract on the 2025 ASCO Annual Meeting website featuring updated interim data from its Phase 1/1b trial. The study evaluated ficerafusp alfa, a first-in-class bifunctional antibody, in combination with pembrolizumab in patients with first line recurrent/metastatic head and neck squamous cell carcinoma. The updated data show promising signals of improved overall survival and durable responses, especially in HPV-negative patients who have few treatment options. The results also included supportive tumor biomarker findings that indicate successful targeting of barriers within the tumor microenvironment. Bicara’s full dataset will be shared during an oral presentation at ASCO, with further details provided on a conference call scheduled for June 1, 2025.

Abstract Presentation - March 25,2025

• Drug: ficerafusp alfa
• Announced Date: March 25, 2025
• Indication: squamous cancer of the anal canal (SCAC).

Bicara Therapeutics Inc. announced that three abstracts relating to the company's lead product candidate, ficerafusp alfa, will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025, which will be held from April 25-30, 2025 in Chicago, IL.

Bicara Therapeutics Inc. announced that three abstracts on its lead product candidate, ficerafusp alfa, will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2025 in Chicago, IL. Ficerafusp alfa is a first-in-class bifunctional antibody that targets both the epidermal growth factor receptor (EGFR) and transforming growth factor beta (TGF-β) in solid tumors. One abstract will focus on Phase 1/1b dose expansion data in patients with advanced cutaneous squamous cell carcinoma. Another abstract discusses dual blockade with pembrolizumab for head and neck cancer, while the third examines preclinical evidence on overcoming drug resistance in KRAS-G12C-mutated lung tumors.

These presentations highlight the therapy’s potential impact on reversing treatment resistance and improving patient outcomes. Detailed session information, including presentation dates and locations, will be available during the meeting and later on the company website, demonstrating an overall promising impact.

Enrollment Update - February 11,2025

Phase 2/3

• Drug: ficerafusp alfa
• Announced Date: February 11, 2025
• Indication: squamous cancer of the anal canal (SCAC).

Bicara Therapeutics Inc. announced the first patients have been enrolled in FORTIFI-HN01, a pivotal Phase 2/3 trial of ficerafusp alfa in combination with pembrolizumab in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

Bicara Therapeutics Inc. has reached an important milestone with the enrollment of the first patients in its FORTIFI-HN01 trial. This pivotal Phase 2/3 study will evaluate the safety and effectiveness of ficerafusp alfa combined with pembrolizumab as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).

Ficerafusp alfa is a first-in-class bifunctional antibody that targets both the epidermal growth factor receptor (EGFR) and human transforming growth factor beta (TGF-β). Early Phase 1/1b results have shown promising anti-tumor activity, which has encouraged the transition to this late-stage trial. The study aims to assess overall response rates and survival outcomes, potentially offering a new treatment option for patients facing this challenging and aggressive disease.

Data Presentation - January 27,2025

Phase 1/1b

• Drug: ficerafusp alfa
• Announced Date: January 27, 2025
• Indication: squamous cancer of the anal canal (SCAC).

Bicara Therapeutics Inc. announced the presentation of data from the Phase 1/1b dose expansion cohort of ficerafusp alfa in combination with pembrolizumab in patients with second line (2L) or later squamous cancer of the anal canal (SCAC).

Bicara Therapeutics Inc. announced promising Phase 1/1b data on its new treatment combining ficerafusp alfa with pembrolizumab for patients with advanced squamous cancer of the anal canal (SCAC) who have already undergone at least one chemotherapy. The study was presented at the 2025 ASCO Gastrointestinal Cancers Symposium and involved 28 patients with immune checkpoint inhibitor–naive SCAC. Results showed a 25% overall response rate, with several patients experiencing partial or complete responses. The combination treatment also improved measures like disease control and 12-month progression-free survival, even among patients with liver metastases. Researchers are hopeful that this dual approach, which targets both tumor growth and the tumor’s ability to suppress the immune response, may offer a more effective treatment option for this high-need patient group, warranting further clinical investigation.