Bicara Therapeutics（BCAX）株式概要バイカラ・セラピューティクス社は臨床段階のバイオ医薬品会社で、固形がんに対する二機能性治療薬の開発に取り組んでいる。 詳細BCAX ファンダメンタル分析スノーフレーク・スコア評価3/6将来の成長0/6過去の実績0/6財務の健全性6/6配当金0/6報酬当社が推定した公正価値より66.8%で取引されている リスク分析収益が 100 万ドル未満 ( $0 )現在は利益が出ておらず、今後3年間で利益が出る見込みはない 過去1年間で株主の希薄化が進んだ すべてのリスクチェックを見るBCAX Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Analyst Price TargetsAN31.7% undervaluedAnalystConsensusTarget•1mo agoPivotal Head And Neck Cancer Trial Will Reshape Prospects For This Bifunctional Antibody Developer1701AN56.6% undervaluedAnalystHighTarget•1mo agoPhase III Progress In Head And Neck Cancer Will Reshape Long Term Outlook000Top Analyst NarrativesAN31.7% undervaluedAnalystConsensusTarget•1mo agoPivotal Head And Neck Cancer Trial Will Reshape Prospects For This Bifunctional Antibody Developer1701AN56.6% undervaluedAnalystHighTarget•1mo agoPhase III Progress In Head And Neck Cancer Will Reshape Long Term Outlook000View all narrativesBicara Therapeutics Inc. 競合他社BiohavenSymbol: NYSE:BHVNMarket cap: US$1.3bSELLAS Life Sciences GroupSymbol: NasdaqCM:SLSMarket cap: US$1.7bMapLight TherapeuticsSymbol: NasdaqGS:MPLTMarket cap: US$1.3bArriVent BioPharmaSymbol: NasdaqGM:AVBPMarket cap: US$1.3b価格と性能株価の高値、安値、推移の概要Bicara Therapeutics過去の株価現在の株価US$20.8452週高値US$24.2552週安値US$7.80ベータ01ヶ月の変化-9.82%3ヶ月変化34.63%1年変化33.08%3年間の変化n/a5年間の変化n/aIPOからの変化-10.98%最新ニュースBoard Change • May 20High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Independent Chairman of the Board Mike Powell was the last director to join the board, commencing their role in 2024. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.お知らせ • May 12Bicara Therapeutics Inc. Announces Executive ChangesBicara Therapeutics Inc. announced that effective May 8, 2026, Bill Schelman, M.D., Ph.D., previously the company’s Executive Vice President, Clinical Development, has succeeded David Raben, M.D., as Chief Medical Officer, and Dr. Raben has transitioned to serve as a Senior Executive Advisor. With this promotion, Dr. Schelman is responsible for medical affairs and clinical development. In his new role, Dr. Raben will advise on clinical development strategy across the company’s portfolio. Announced that effective May 8, 2026, Chris Sarchi was appointed as Chief Commercial Officer. In this role, he will lead the commercial organization in preparation for launch readiness.ライブニュース • May 12Bicara Therapeutics Advances Ficerafusp Alfa With $540 Million Cash and Leadership AdditionsBicara Therapeutics reported Q1 2026 results, with a loss of $0.93 per share that came in 40.9% below analyst estimates, and ended the quarter with about $540m in cash, which the company expects to support operations into mid-2029. The lead asset, bifunctional antibody ficerafusp alfa, is progressing in the pivotal Phase 2/3 FORTIFI-HN01 trial in HPV-negative head and neck squamous cell carcinoma, with an interim analysis planned by mid-2027 to support a potential accelerated FDA approval. Bicara plans to start a randomized loading and maintenance dosing study of ficerafusp alfa plus pembrolizumab in Q3 2026 and to present mature Phase 1b data at ASCO 2026. The company has promoted Bill Schelman to Chief Medical Officer and appointed Chris Sarchi as Chief Commercial Officer to prepare for potential commercialization. The key takeaway is that Bicara is pairing a large cash position with an advancing late-stage pipeline and upcoming clinical catalysts, while also building out its commercial leadership bench early. Investors may want to weigh the widened loss and the clinical, regulatory and execution risks typical of late-stage biotech against the extended cash runway and the concentration in a single lead program.お知らせ • May 04Bicara Therapeutics Inc. to Report Q1, 2026 Results on May 11, 2026Bicara Therapeutics Inc. announced that they will report Q1, 2026 results Pre-Market on May 11, 2026お知らせ • Apr 30Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2026Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2026.新しいナラティブ • Apr 16Phase III Progress In Head And Neck Cancer Will Reshape Long Term OutlookCatalysts About Bicara Therapeutics Bicara Therapeutics is a clinical stage biotech company developing bifunctional antibodies for targeted tumor modulation, with a focus on its lead asset FICERA in HPV negative head and neck cancer. What are the underlying business or industry changes driving this perspective?最新情報をもっと見るRecent updatesBoard Change • May 20High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Independent Chairman of the Board Mike Powell was the last director to join the board, commencing their role in 2024. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.お知らせ • May 12Bicara Therapeutics Inc. Announces Executive ChangesBicara Therapeutics Inc. announced that effective May 8, 2026, Bill Schelman, M.D., Ph.D., previously the company’s Executive Vice President, Clinical Development, has succeeded David Raben, M.D., as Chief Medical Officer, and Dr. Raben has transitioned to serve as a Senior Executive Advisor. With this promotion, Dr. Schelman is responsible for medical affairs and clinical development. In his new role, Dr. Raben will advise on clinical development strategy across the company’s portfolio. Announced that effective May 8, 2026, Chris Sarchi was appointed as Chief Commercial Officer. In this role, he will lead the commercial organization in preparation for launch readiness.ライブニュース • May 12Bicara Therapeutics Advances Ficerafusp Alfa With $540 Million Cash and Leadership AdditionsBicara Therapeutics reported Q1 2026 results, with a loss of $0.93 per share that came in 40.9% below analyst estimates, and ended the quarter with about $540m in cash, which the company expects to support operations into mid-2029. The lead asset, bifunctional antibody ficerafusp alfa, is progressing in the pivotal Phase 2/3 FORTIFI-HN01 trial in HPV-negative head and neck squamous cell carcinoma, with an interim analysis planned by mid-2027 to support a potential accelerated FDA approval. Bicara plans to start a randomized loading and maintenance dosing study of ficerafusp alfa plus pembrolizumab in Q3 2026 and to present mature Phase 1b data at ASCO 2026. The company has promoted Bill Schelman to Chief Medical Officer and appointed Chris Sarchi as Chief Commercial Officer to prepare for potential commercialization. The key takeaway is that Bicara is pairing a large cash position with an advancing late-stage pipeline and upcoming clinical catalysts, while also building out its commercial leadership bench early. Investors may want to weigh the widened loss and the clinical, regulatory and execution risks typical of late-stage biotech against the extended cash runway and the concentration in a single lead program.お知らせ • May 04Bicara Therapeutics Inc. to Report Q1, 2026 Results on May 11, 2026Bicara Therapeutics Inc. announced that they will report Q1, 2026 results Pre-Market on May 11, 2026お知らせ • Apr 30Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2026Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2026.新しいナラティブ • Apr 16Phase III Progress In Head And Neck Cancer Will Reshape Long Term OutlookCatalysts About Bicara Therapeutics Bicara Therapeutics is a clinical stage biotech company developing bifunctional antibodies for targeted tumor modulation, with a focus on its lead asset FICERA in HPV negative head and neck cancer. What are the underlying business or industry changes driving this perspective?新しいナラティブ • Apr 02Pivotal Head And Neck Cancer Trial Will Reshape Prospects For This Bifunctional Antibody DeveloperCatalysts About Bicara Therapeutics Bicara Therapeutics is a clinical stage biotech company focused on bifunctional antibodies for targeted tumor modulation, led by its FICERA program in HPV negative head and neck cancer. What are the underlying business or industry changes driving this perspective?Seeking Alpha • Mar 31Bicara: Maintaining 'Buy' Rating On Ficerafusp Alfa Phase 3 AdvancementSummary Bicara Therapeutics Inc. maintains a Buy rating, driven by progress in its pivotal phase 3 FORTIFI-HN01 study for 1st-line R/M HPV-negative HNSCC. BCAX's ficerafusp alfa plus KEYTRUDA achieved a 12-month OS of 61% and a confirmed ORR of 54% in phase 1/1b, supporting continued development. Key upcoming catalysts for BCAX include phase 3 interim data in mid-2027 and long-term phase 1b follow-up at ASCO 2026, with near-full enrollment expected by year-end. BCAX is well-capitalized, with more than $414.8M in cash and funding runway into H1 2029, but faces competitive risk from Genmab’s petosemtamab and trial readouts. Read the full article on Seeking Alphaお知らせ • Mar 23Bicara Therapeutics Inc. to Report Q4, 2025 Results on Mar 30, 2026Bicara Therapeutics Inc. announced that they will report Q4, 2025 results Pre-Market on Mar 30, 2026お知らせ • Feb 25+ 1 more updateBicara Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $149.99978 million.Bicara Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $149.99978 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 7,175,000 Price\Range: $16 Discount Per Security: $0.96 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 2,200,000 Price\Range: $15.9999 Discount Per Security: $0.96お知らせ • Feb 20Bicara Therapeutics Inc. Presents Preliminary Safety and Efficacy Data from an Exploratory Phase 1b Expansion Cohort Evaluating 2000mg of Ficerafusp Alfa Every Other Week in Combination with Pembrolizumab in 1L HPV-Negative HNSCCBicara Therapeutics Inc. 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 is currently evaluating ficerafusp alfa at 1500mg weekly (QW) in Phase 3 of the ongoing FORTIFI-HN01 pivotal study. Results from this alternative dosing cohort, including rapid, deep and durable responses, a consistent safety profile, and sustained TGF- neutralization in 1L HPV-negative R M HNSCC patients, reinforce the strength of ficerafusp alFA's differentiated mechanism of action," said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. The Phase 1b expansion cohort data presented at MHNCS show that 2000mg Q2W ficerafusp alfa in combination with pembrolIZumab was generally well-tolerated, with a safety profile consistent with the known safety profile of ficerafusp alf plus pembrolizumab In R M HNSCC. The growing body of pharmacokinetic, translational and clinical data supports development of an additional dose regimen that optimizes efficacy, safety and convenience without compromising the depth nor durability of response that are characteristic of ficeraf Susp alfa's differentiated clinical profile. Bicara plans to develop ficerafusp alfa with a loading and every-three-week maintenance schedule and aims to achieve regulatory alignment to enable data generation by potential U.S. approval. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation 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-ligand1 with combined positive score (CPS)1, excluding human papillomav virus (HPV)-positive oropharyngeal squamous cell carcinoma. Ficerafusp alfa is currently being evaluated in FORTIFI-H N01, a pivotal Phase 2 clinical trial in patients with 1L R M HNSCC. Factors that could cause actual results to difference include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct of clinical trials uncertainties as to the availability and timing of results and data from clinical trials whether results from prior preclinical studies, preliminary or interim data from earlier stage clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials regulatory developments in the United States and foreign countries whether Bicara's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements as well as the risks and uncertainties identified in Bicara's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10--FDA), including its annual Report on Form 10-FDA (SEC), including its Annual report on Form 10-FDA).お知らせ • Jan 13Bicara Therapeutics Announces Phase 3 Optimal Dose for the Treatment of 1L HPV-negative R/M HNSCC in Phase 3 FORTIFI-HN01 Pivotal StudyBicara Therapeutics Inc. has aligned with the U.S. Food and Drug Administration (FDA) on a clear path to implement, by the end of the first quarter, the optimal dose for Phase 3 of FORTIFI-HN01, a global, randomized, double-blind, placebo-controlled, pivotal trial of ficerafusp alfa in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The company anticipates that FORTIFI-HN01 will be substantially enrolled by the end of 2026 to enable an interim analysis in the middle of 2027.Ficerafusp alfa has the potential to achieve blockbuster status in HPV-negative R/M HNSCC, a multi-billion-dollar market that continues to grow. HPV-negative R/M HNSCC is a biologically distinct disease, often marked by immune exclusion and a hostile tumor microenvironment that limits the depth and durability of response to currently available therapies. Moreover, the majority of patients rapidly develop therapeutic resistance, underscoring the urgent need for more effective and durable treatment options. Ficerafusp alfa has a proven clinical dataset that more than doubles median overall survival in HPV-negative patients compared to standard of care and substantially improves upon median duration of response compared to other pembrolizumab combinations, including other approved and investigational EGFR-targeting agents. With increased conviction in ficerafusp alfa’s clinical potential, and as the company accelerates enrollment in the FORTIFI-HN01 pivotal study, Bicara plans to make critical commercial hires in 2026 to establish a strong foundation for future commercial success. Ficerafusp alfa is the first and only bifunctional EGFR-directed antibody combined with a TGF-ß ligand trap designed to drive increased tumor penetration and improve survival outcomes. By simultaneously targeting EGFR-expressing tumor cells and modulating TGF-ß–driven tumor microenvironment signaling, ficerafusp alfa is designed to improve tumor accessibility and enable more effective immune activity within the tumor. This bifunctional approach is intended to support deeper and more durable anti-tumor responses when used in combination with immune checkpoint inhibitors. There is a compelling biological rationale to explore ficerafusp alfa’s potential in solid tumors outside of HNSCC, especially in indications where EGFR is overexpressed and TGF-ß signaling contributes to tumor progression. Bicara is currently evaluating ficerafusp alfa in metastatic colorectal cancer (mCRC) and plans to expand signal-finding efforts in other solid tumors with significant unmet need to further evaluate ficerafusp alfa’s pipeline-in-a-product potential.お知らせ • Dec 08Bicara Therapeutics Inc. Presents Preliminary Phase 1b Expansion Cohort Data Evaluating 750mg of Ficerafusp Alfa Weekly PlusBicara 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). The data were highlighted in an oral presentation by Deborah Wong, MD, PhD of UCLA Medical Center at the European Society for Medical Oncology (ESMO) Asia Congress and will be discussed on a company conference call and webcast today, December 6, at 9:00 a.m. ET. Phase 1/1b expansion cohort data presented at ESMO Asia show that 750mg ficerafusp alfa in combination with pembrolIZumab was generally well-tolerated, with a safety profile consistent with the known safety profile of ficerafusp alFA plus pembrolizumab In R/M HNSCC. New biomarker data to be presented during Bicara's corporate call and webcast show that 1500mg of ficerafusp alfa yielded a greater increase TGF-b inhibition within the tumor microenvironment and greater immune activation, compared to 750mg of ficerafusp Alfa. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation 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 carcinomas (HNSCC) whose tumors express programmed death-ligand1 with combined positive score (CPS)1, excluding human papillomavirus ("HPV)-positive oropharyngeal squamous cell carcinoma. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial in patients with 1L R/M HNSCC". Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct of clinical trials; uncertainties as to the availability and timing of results and data from clinical trials; whether results from prior preclinical studies, preliminary or interim data from earlier stage clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; whether Bicara's cash resources will be sufficient to fund its unforeseeable and unforeseeable operating expenses and capital expenditure requirements; as a result of the development of product candidates, as a result of the results of subsequent pre clinical studies and clinical trials; and whether Bicara's cash Resources will be sufficient to fund its future and unforeseeable operating costs and capital expenditure requirements; as a result of the results in the U.S. and the results of the first quarter of 2026.お知らせ • Dec 01Bicara Therapeutics Announces Publication of an Abstract with Preliminary Phase 1B Expansion Cohort Data Evaluating 750Mg of Ficerafusp Alfa Weekly Plus Pembrolizumab in 1L Hpv-Negative R/M Hnscc At Esmo Asia 2025Bicara 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). The results will be highlighted in an oral presentation at the upcoming European Society for Medical Oncology (ESMO) Asia Congress and will be discussed on a company conference call and webcast on Saturday, December 6, at 9:00 a.m. ET. Key highlights of the abstract include: Expansion cohort data (July 9, 2025 cutoff date) from the Phase 1/1b clinical trial of ficerafusp alf in patients with 1L HPV-negative R/M HNSCC evaluating 750mg of Ficerafusp alfa weekly in combination with pembrolIZumab. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ficerafusp alfa in combination with pembrolizeumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) Head and neck squamous cell carcinomas (HNSCC) whose tumors express programmed death-ligand1 with combined positive score (CPS)1, excluding human papillomavirus ("HPV)-positive oropharyngeal squamous cell carcinoma. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial in patients with 1L R/M HNSCC. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct of clinical trials; uncertainties as to the availability and timing of results and data from clinical trials; whether results from prior preclinical studies and clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; whether Bicara's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Bicara's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and the Company to host conference call and webcast on December 6, 2025.お知らせ • Oct 13Bicara Therapeutics Announces Ficerafusp Alfa Granted Breakthrough Therapy Designation by U.S. FDA for 1L HPV-Negative R/M HNSCCBicara 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-ligand1 with combined positive score (CPS)1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. This designation from the FDA underscores the growing recognition of HPV-negative HNSCC as a distinct clinical indication within head and neck cancer - one with particularly poor outcomes, limited therapeutic options, and that represents the vast majority of patients. BTD was supported by results from multiple Phase 1/1b dose cohorts evaluating ficerafusp alfa In combination with pembrolizUMab in patients with 1L HPV-negative R/M HNSCC. Data most recently presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated deep and durable clinical benefit with a median duration of response of 21.7 months, and a median overall survival of 21.3 months, alongside a favorable safety and tolerability profile. BTD is intended to expedite the development and review of potential new medicines that show substantial improvement over available therapies for serious or life-threatening conditions, providing greater interaction with the FDA, involvement of senior agency leadership, and eligibility for rolling and priority review.分析記事 • Jul 15We're Not Very Worried About Bicara Therapeutics' (NASDAQ:BCAX) Cash Burn RateWe can readily understand why investors are attracted to unprofitable companies. For example, although Amazon.com made...お知らせ • Jun 02Bicara Therapeutics Inc. Demonstrates Deep and Durable Responses with Ficerafusp Alfa Plus Pembrolizumab in 1L HPV-Negative R/M HNSCC at ASCO 2025Bicara 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. Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-ß). In the Phase 1/1b trial, ficerafusp alfa in combination with pembrolizumab resulted in deep and durable anti-tumor activity with improved overall survival (OS) compared to historical benchmarks in patients with 1L R/M human papillomavirus (HPV)-negative HNSCC with a PD-L1 combined positive score (CPS) of =1 and with at least 24 months of follow-up. In the efficacy evaluable human papillomavirus (HPV)-negative population (n=28): Median duration of response (DOR) of 21.7 months amongst responders (n=15). Median OS of 21.3 months; 2-year OS rate of 46%. 54% (15/28) confirmed objective response rate (ORR); 64% (18/28) ORR, including an additional three unconfirmed responses. 21% (6/28) complete response rate. 80% (12/15) of responders achieved a deep response (=80% tumor shrinkage). Disease control rate of 89% (25/28 patients). Median progression-free survival of 9.9 months. Manageable safety profile consistent with previously reported adverse events.お知らせ • Apr 29Bicara Therapeutics Inc. Highlights Broad Potential of Ficerafusp Alfa at AACR Annual Meeting 2025Bicara Therapeutics Inc. announced multiple presentations related to ficerafusp alfa at the American Association for Cancer Research (AACR) Annual Meeting 2025. Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-b) and is being evaluated across multiple solid tumor types.お知らせ • Apr 28Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2025Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2025.お知らせ • Apr 23Bicara Therapeutics to Present Updated Data from Ongoing Phase 1/1B Trial of Ficerafusp Alfa in 1L R/M HNSCC At the 2025 American Society of Clinical Oncology Annual MeetingBicara Therapeutics Inc. announced that updated data from the company's ongoing Phase 1/1b clinical trial of ficerafusp alfa in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) will be highlighted in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from May 30-June 3, 2025 in Chicago, IL. Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-b) and is being evaluated across multiple solid tumor types. Ficerafusp alf is a first-in- class bifunctional antibody that combine two clinically validated targets, an epidermal growth factor receptors (EGFR) directed monOClonal antibody with a domain That binds to human transforming growth factor Beta (TGF-b). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-b signaling within the tumor microenvironment. Ficerafusp alFA is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial 1L (first line)urrent/metastatic (R-M) head and neck squ Famous cell carcinoma (H NSCC).Seeking Alpha • Apr 19Bicara: Innovative Precision Tumor TargetingSummary Bicara Therapeutics' lead candidate, ficerafusp alfa, targets EGFR and TGF-beta in tumors, showing promise in hard-to-treat cancers like Head and Neck Squamous Cell Carcinoma. Bicara's financial health is robust, with $489.7 million in cash, ensuring operations through mid-2029, bolstered by a successful IPO and Series C funding. Early clinical data for ficerafusp alfa plus pembrolizumab in HPV-negative HNSCC shows significant antitumor activity and manageable safety, supporting its potential market impact. Bicara's pivotal Phase 2/3 trial could establish ficerafusp alfa as a new standard of care, with a potential market revenue of $1.3 billion annually. Read the full article on Seeking Alpha分析記事 • Mar 13We Think Bicara Therapeutics (NASDAQ:BCAX) Can Afford To Drive Business GrowthJust because a business does not make any money, does not mean that the stock will go down. For example, although...お知らせ • Feb 13Bicara Therapeutics Announces First Patients Enrolled in FORTIFI-HN01, a Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in 1L Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaBicara 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). Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-ß). FORTIFI-HN01 is a global, randomized, double-blinded, placebo-controlled, pivotal Phase 2/3 trial that aims to enroll approximately 650 R/M HNSCC patients, excluding patients with human papillomavirus (HPV)-positive with oropharyngeal squamous cell carcinoma. Patients enrolled in the trial must have a PD-L1 CPS greater than or equal to one, and not have received systemic therapy in the R/M setting. The primary endpoints are overall response rate based on RECIST v1.1 and overall survival, with results potentially supporting filings for both accelerated approval and full approval. Secondary endpoints include progression free survival and duration of response.Seeking Alpha • Feb 02Bicara Therapeutics: A Decline Off The IPO Spells 'Wait' For MeSummary Bicara Therapeutics is a new biotech firm focusing on innovative cancer treatments, currently advancing its lead candidate, ficerafusp alfa, targeting challenging cancers like HNSCC. BCAX's financial health is strong, with sufficient capital to fund operations for about four years, but relies heavily on the success of ficerafusp alfa. Early trial results for ficerafusp alfa show promise, particularly in HPV-negative HNSCC, but the lack of diverse pipeline and early-stage data pose significant risks. Given the long wait for potential approval and high volatility, BCAX is a speculative investment better suited for patient, risk-tolerant investors, and I would personally watch for a favorable entry point. Read the full article on Seeking Alphaお知らせ • Jan 28Bicara Therapeutics Presents Phase 1/1B Dose Expansion Results with Ficerafusp Alfa in Advanced Squamous Cancer of the Anal Canal At the 2025 Asco Gastrointestinal Cancers SymposiumBicara 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). The results were presented in a poster session during the 2025 ASCO Gastrointestinal (GI) Cancers Symposium on Saturday, January 25, 2025. Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-b), and is being evaluated in multiple solid tumor types. The addition of ficeraf Susp alfa shows the potential to improve efficacy compared to historical data with pembrolizumib monotherapy in SCAC, with increased overall response rate, disease control rate, and 12-month progression-free survival, indicative of improved speed, depth, and durability of response. Importantly, responses were observed even in patients with liver metastases, which is a significant outcome in this setting. Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-b signaling within the tumor microenvironment.お知らせ • Sep 14Bicara Therapeutics Inc. has completed an IPO in the amount of $315 million.Bicara Therapeutics Inc. has completed an IPO in the amount of $315 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 17,500,000 Price\Range: $18 Discount Per Security: $1.26 Transaction Features: Reserved Share Offering; Sponsor Backed Offering株主還元BCAXUS BiotechsUS 市場7D0.9%-1.6%-0.8%1Y33.1%34.4%27.1%株主還元を見る業界別リターン: BCAX過去 1 年間で34.4 % のリターンをもたらしたUS Biotechs業界と一致しました。リターン対市場: BCAX過去 1 年間で27.1 % の収益を上げたUS市場を上回りました。価格変動Is BCAX's price volatile compared to industry and market?BCAX volatilityBCAX Average Weekly Movement6.9%Biotechs Industry Average Movement11.0%Market Average Movement7.2%10% most volatile stocks in US Market16.3%10% least volatile stocks in US Market3.2%安定した株価: BCAX 、 US市場と比較して、過去 3 か月間で大きな価格変動はありませんでした。時間の経過による変動: BCAXの 週次ボラティリティ ( 7% ) は過去 1 年間安定しています。会社概要設立従業員CEO（最高経営責任者ウェブサイト2018103Claire Mazumdar Clemonwww.bicara.comバイカラ・セラピューティクス社は臨床段階にあるバイオ医薬品会社で、固形がんに対する二機能性治療薬の開発に取り組んでいる。同社のリードプログラムは、臨床的に検証された上皮成長因子受容体指向性モノクローナル抗体とヒト形質転換成長因子ベータを結合させた固形がん治療用の二機能性抗体であるficerafusp alfaである。同社は2018年に法人化され、マサチューセッツ州ボストンを拠点としている。もっと見るBicara Therapeutics Inc. 基礎のまとめBicara Therapeutics の収益と売上を時価総額と比較するとどうか。BCAX 基礎統計学時価総額US$1.34b収益（TTM）-US$157.31m売上高(TTM)n/a0.0xP/Sレシオ-8.7xPER（株価収益率BCAX は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計BCAX 損益計算書（TTM）収益US$0売上原価US$0売上総利益US$0その他の費用US$157.32m収益-US$157.31m直近の収益報告Mar 31, 2026次回決算日該当なし一株当たり利益（EPS）-2.39グロス・マージン0.00%純利益率0.00%有利子負債／自己資本比率0%BCAX の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/21 07:16終値2026/05/21 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Bicara Therapeutics Inc. 13 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。16 アナリスト機関Tazeen AhmadBofA Global ResearchSuranjit MukherjeeBTIGEric SchmidtCantor Fitzgerald & Co.13 その他のアナリストを表示
Board Change • May 20High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Independent Chairman of the Board Mike Powell was the last director to join the board, commencing their role in 2024. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.
お知らせ • May 12Bicara Therapeutics Inc. Announces Executive ChangesBicara Therapeutics Inc. announced that effective May 8, 2026, Bill Schelman, M.D., Ph.D., previously the company’s Executive Vice President, Clinical Development, has succeeded David Raben, M.D., as Chief Medical Officer, and Dr. Raben has transitioned to serve as a Senior Executive Advisor. With this promotion, Dr. Schelman is responsible for medical affairs and clinical development. In his new role, Dr. Raben will advise on clinical development strategy across the company’s portfolio. Announced that effective May 8, 2026, Chris Sarchi was appointed as Chief Commercial Officer. In this role, he will lead the commercial organization in preparation for launch readiness.
ライブニュース • May 12Bicara Therapeutics Advances Ficerafusp Alfa With $540 Million Cash and Leadership AdditionsBicara Therapeutics reported Q1 2026 results, with a loss of $0.93 per share that came in 40.9% below analyst estimates, and ended the quarter with about $540m in cash, which the company expects to support operations into mid-2029. The lead asset, bifunctional antibody ficerafusp alfa, is progressing in the pivotal Phase 2/3 FORTIFI-HN01 trial in HPV-negative head and neck squamous cell carcinoma, with an interim analysis planned by mid-2027 to support a potential accelerated FDA approval. Bicara plans to start a randomized loading and maintenance dosing study of ficerafusp alfa plus pembrolizumab in Q3 2026 and to present mature Phase 1b data at ASCO 2026. The company has promoted Bill Schelman to Chief Medical Officer and appointed Chris Sarchi as Chief Commercial Officer to prepare for potential commercialization. The key takeaway is that Bicara is pairing a large cash position with an advancing late-stage pipeline and upcoming clinical catalysts, while also building out its commercial leadership bench early. Investors may want to weigh the widened loss and the clinical, regulatory and execution risks typical of late-stage biotech against the extended cash runway and the concentration in a single lead program.
お知らせ • May 04Bicara Therapeutics Inc. to Report Q1, 2026 Results on May 11, 2026Bicara Therapeutics Inc. announced that they will report Q1, 2026 results Pre-Market on May 11, 2026
お知らせ • Apr 30Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2026Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2026.
新しいナラティブ • Apr 16Phase III Progress In Head And Neck Cancer Will Reshape Long Term OutlookCatalysts About Bicara Therapeutics Bicara Therapeutics is a clinical stage biotech company developing bifunctional antibodies for targeted tumor modulation, with a focus on its lead asset FICERA in HPV negative head and neck cancer. What are the underlying business or industry changes driving this perspective?
Board Change • May 20High number of new directorsThere are 5 new directors who have joined the board in the last 3 years. Independent Chairman of the Board Mike Powell was the last director to join the board, commencing their role in 2024. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.
お知らせ • May 12Bicara Therapeutics Inc. Announces Executive ChangesBicara Therapeutics Inc. announced that effective May 8, 2026, Bill Schelman, M.D., Ph.D., previously the company’s Executive Vice President, Clinical Development, has succeeded David Raben, M.D., as Chief Medical Officer, and Dr. Raben has transitioned to serve as a Senior Executive Advisor. With this promotion, Dr. Schelman is responsible for medical affairs and clinical development. In his new role, Dr. Raben will advise on clinical development strategy across the company’s portfolio. Announced that effective May 8, 2026, Chris Sarchi was appointed as Chief Commercial Officer. In this role, he will lead the commercial organization in preparation for launch readiness.
ライブニュース • May 12Bicara Therapeutics Advances Ficerafusp Alfa With $540 Million Cash and Leadership AdditionsBicara Therapeutics reported Q1 2026 results, with a loss of $0.93 per share that came in 40.9% below analyst estimates, and ended the quarter with about $540m in cash, which the company expects to support operations into mid-2029. The lead asset, bifunctional antibody ficerafusp alfa, is progressing in the pivotal Phase 2/3 FORTIFI-HN01 trial in HPV-negative head and neck squamous cell carcinoma, with an interim analysis planned by mid-2027 to support a potential accelerated FDA approval. Bicara plans to start a randomized loading and maintenance dosing study of ficerafusp alfa plus pembrolizumab in Q3 2026 and to present mature Phase 1b data at ASCO 2026. The company has promoted Bill Schelman to Chief Medical Officer and appointed Chris Sarchi as Chief Commercial Officer to prepare for potential commercialization. The key takeaway is that Bicara is pairing a large cash position with an advancing late-stage pipeline and upcoming clinical catalysts, while also building out its commercial leadership bench early. Investors may want to weigh the widened loss and the clinical, regulatory and execution risks typical of late-stage biotech against the extended cash runway and the concentration in a single lead program.
お知らせ • May 04Bicara Therapeutics Inc. to Report Q1, 2026 Results on May 11, 2026Bicara Therapeutics Inc. announced that they will report Q1, 2026 results Pre-Market on May 11, 2026
お知らせ • Apr 30Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2026Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2026.
新しいナラティブ • Apr 16Phase III Progress In Head And Neck Cancer Will Reshape Long Term OutlookCatalysts About Bicara Therapeutics Bicara Therapeutics is a clinical stage biotech company developing bifunctional antibodies for targeted tumor modulation, with a focus on its lead asset FICERA in HPV negative head and neck cancer. What are the underlying business or industry changes driving this perspective?
新しいナラティブ • Apr 02Pivotal Head And Neck Cancer Trial Will Reshape Prospects For This Bifunctional Antibody DeveloperCatalysts About Bicara Therapeutics Bicara Therapeutics is a clinical stage biotech company focused on bifunctional antibodies for targeted tumor modulation, led by its FICERA program in HPV negative head and neck cancer. What are the underlying business or industry changes driving this perspective?
Seeking Alpha • Mar 31Bicara: Maintaining 'Buy' Rating On Ficerafusp Alfa Phase 3 AdvancementSummary Bicara Therapeutics Inc. maintains a Buy rating, driven by progress in its pivotal phase 3 FORTIFI-HN01 study for 1st-line R/M HPV-negative HNSCC. BCAX's ficerafusp alfa plus KEYTRUDA achieved a 12-month OS of 61% and a confirmed ORR of 54% in phase 1/1b, supporting continued development. Key upcoming catalysts for BCAX include phase 3 interim data in mid-2027 and long-term phase 1b follow-up at ASCO 2026, with near-full enrollment expected by year-end. BCAX is well-capitalized, with more than $414.8M in cash and funding runway into H1 2029, but faces competitive risk from Genmab’s petosemtamab and trial readouts. Read the full article on Seeking Alpha
お知らせ • Mar 23Bicara Therapeutics Inc. to Report Q4, 2025 Results on Mar 30, 2026Bicara Therapeutics Inc. announced that they will report Q4, 2025 results Pre-Market on Mar 30, 2026
お知らせ • Feb 25+ 1 more updateBicara Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $149.99978 million.Bicara Therapeutics Inc. has completed a Follow-on Equity Offering in the amount of $149.99978 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 7,175,000 Price\Range: $16 Discount Per Security: $0.96 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 2,200,000 Price\Range: $15.9999 Discount Per Security: $0.96
お知らせ • Feb 20Bicara Therapeutics Inc. Presents Preliminary Safety and Efficacy Data from an Exploratory Phase 1b Expansion Cohort Evaluating 2000mg of Ficerafusp Alfa Every Other Week in Combination with Pembrolizumab in 1L HPV-Negative HNSCCBicara Therapeutics Inc. 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 is currently evaluating ficerafusp alfa at 1500mg weekly (QW) in Phase 3 of the ongoing FORTIFI-HN01 pivotal study. Results from this alternative dosing cohort, including rapid, deep and durable responses, a consistent safety profile, and sustained TGF- neutralization in 1L HPV-negative R M HNSCC patients, reinforce the strength of ficerafusp alFA's differentiated mechanism of action," said David Raben, MD, Chief Medical Officer of Bicara Therapeutics. The Phase 1b expansion cohort data presented at MHNCS show that 2000mg Q2W ficerafusp alfa in combination with pembrolIZumab was generally well-tolerated, with a safety profile consistent with the known safety profile of ficerafusp alf plus pembrolizumab In R M HNSCC. The growing body of pharmacokinetic, translational and clinical data supports development of an additional dose regimen that optimizes efficacy, safety and convenience without compromising the depth nor durability of response that are characteristic of ficeraf Susp alfa's differentiated clinical profile. Bicara plans to develop ficerafusp alfa with a loading and every-three-week maintenance schedule and aims to achieve regulatory alignment to enable data generation by potential U.S. approval. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation 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-ligand1 with combined positive score (CPS)1, excluding human papillomav virus (HPV)-positive oropharyngeal squamous cell carcinoma. Ficerafusp alfa is currently being evaluated in FORTIFI-H N01, a pivotal Phase 2 clinical trial in patients with 1L R M HNSCC. Factors that could cause actual results to difference include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct of clinical trials uncertainties as to the availability and timing of results and data from clinical trials whether results from prior preclinical studies, preliminary or interim data from earlier stage clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials regulatory developments in the United States and foreign countries whether Bicara's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements as well as the risks and uncertainties identified in Bicara's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10--FDA), including its annual Report on Form 10-FDA (SEC), including its Annual report on Form 10-FDA).
お知らせ • Jan 13Bicara Therapeutics Announces Phase 3 Optimal Dose for the Treatment of 1L HPV-negative R/M HNSCC in Phase 3 FORTIFI-HN01 Pivotal StudyBicara Therapeutics Inc. has aligned with the U.S. Food and Drug Administration (FDA) on a clear path to implement, by the end of the first quarter, the optimal dose for Phase 3 of FORTIFI-HN01, a global, randomized, double-blind, placebo-controlled, pivotal trial of ficerafusp alfa in combination with pembrolizumab in first-line (1L) human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). The company anticipates that FORTIFI-HN01 will be substantially enrolled by the end of 2026 to enable an interim analysis in the middle of 2027.Ficerafusp alfa has the potential to achieve blockbuster status in HPV-negative R/M HNSCC, a multi-billion-dollar market that continues to grow. HPV-negative R/M HNSCC is a biologically distinct disease, often marked by immune exclusion and a hostile tumor microenvironment that limits the depth and durability of response to currently available therapies. Moreover, the majority of patients rapidly develop therapeutic resistance, underscoring the urgent need for more effective and durable treatment options. Ficerafusp alfa has a proven clinical dataset that more than doubles median overall survival in HPV-negative patients compared to standard of care and substantially improves upon median duration of response compared to other pembrolizumab combinations, including other approved and investigational EGFR-targeting agents. With increased conviction in ficerafusp alfa’s clinical potential, and as the company accelerates enrollment in the FORTIFI-HN01 pivotal study, Bicara plans to make critical commercial hires in 2026 to establish a strong foundation for future commercial success. Ficerafusp alfa is the first and only bifunctional EGFR-directed antibody combined with a TGF-ß ligand trap designed to drive increased tumor penetration and improve survival outcomes. By simultaneously targeting EGFR-expressing tumor cells and modulating TGF-ß–driven tumor microenvironment signaling, ficerafusp alfa is designed to improve tumor accessibility and enable more effective immune activity within the tumor. This bifunctional approach is intended to support deeper and more durable anti-tumor responses when used in combination with immune checkpoint inhibitors. There is a compelling biological rationale to explore ficerafusp alfa’s potential in solid tumors outside of HNSCC, especially in indications where EGFR is overexpressed and TGF-ß signaling contributes to tumor progression. Bicara is currently evaluating ficerafusp alfa in metastatic colorectal cancer (mCRC) and plans to expand signal-finding efforts in other solid tumors with significant unmet need to further evaluate ficerafusp alfa’s pipeline-in-a-product potential.
お知らせ • Dec 08Bicara Therapeutics Inc. Presents Preliminary Phase 1b Expansion Cohort Data Evaluating 750mg of Ficerafusp Alfa Weekly PlusBicara 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). The data were highlighted in an oral presentation by Deborah Wong, MD, PhD of UCLA Medical Center at the European Society for Medical Oncology (ESMO) Asia Congress and will be discussed on a company conference call and webcast today, December 6, at 9:00 a.m. ET. Phase 1/1b expansion cohort data presented at ESMO Asia show that 750mg ficerafusp alfa in combination with pembrolIZumab was generally well-tolerated, with a safety profile consistent with the known safety profile of ficerafusp alFA plus pembrolizumab In R/M HNSCC. New biomarker data to be presented during Bicara's corporate call and webcast show that 1500mg of ficerafusp alfa yielded a greater increase TGF-b inhibition within the tumor microenvironment and greater immune activation, compared to 750mg of ficerafusp Alfa. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation 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 carcinomas (HNSCC) whose tumors express programmed death-ligand1 with combined positive score (CPS)1, excluding human papillomavirus ("HPV)-positive oropharyngeal squamous cell carcinoma. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial in patients with 1L R/M HNSCC". Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct of clinical trials; uncertainties as to the availability and timing of results and data from clinical trials; whether results from prior preclinical studies, preliminary or interim data from earlier stage clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; whether Bicara's cash resources will be sufficient to fund its unforeseeable and unforeseeable operating expenses and capital expenditure requirements; as a result of the development of product candidates, as a result of the results of subsequent pre clinical studies and clinical trials; and whether Bicara's cash Resources will be sufficient to fund its future and unforeseeable operating costs and capital expenditure requirements; as a result of the results in the U.S. and the results of the first quarter of 2026.
お知らせ • Dec 01Bicara Therapeutics Announces Publication of an Abstract with Preliminary Phase 1B Expansion Cohort Data Evaluating 750Mg of Ficerafusp Alfa Weekly Plus Pembrolizumab in 1L Hpv-Negative R/M Hnscc At Esmo Asia 2025Bicara 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). The results will be highlighted in an oral presentation at the upcoming European Society for Medical Oncology (ESMO) Asia Congress and will be discussed on a company conference call and webcast on Saturday, December 6, at 9:00 a.m. ET. Key highlights of the abstract include: Expansion cohort data (July 9, 2025 cutoff date) from the Phase 1/1b clinical trial of ficerafusp alf in patients with 1L HPV-negative R/M HNSCC evaluating 750mg of Ficerafusp alfa weekly in combination with pembrolIZumab. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ficerafusp alfa in combination with pembrolizeumab for the first line (1L) treatment of patients with metastatic or with unresectable, recurrent (R/M) Head and neck squamous cell carcinomas (HNSCC) whose tumors express programmed death-ligand1 with combined positive score (CPS)1, excluding human papillomavirus ("HPV)-positive oropharyngeal squamous cell carcinoma. Ficerafusp alfa is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial in patients with 1L R/M HNSCC. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to uncertainties inherent in the development of product candidates, including the conduct of research activities and the conduct of clinical trials; uncertainties as to the availability and timing of results and data from clinical trials; whether results from prior preclinical studies and clinical trials will be predictive of the results of subsequent preclinical studies and clinical trials; regulatory developments in the United States and foreign countries; whether Bicara's cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; as well as the risks and uncertainties identified in Bicara's filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2025, and the Company to host conference call and webcast on December 6, 2025.
お知らせ • Oct 13Bicara Therapeutics Announces Ficerafusp Alfa Granted Breakthrough Therapy Designation by U.S. FDA for 1L HPV-Negative R/M HNSCCBicara 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-ligand1 with combined positive score (CPS)1, excluding human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma. This designation from the FDA underscores the growing recognition of HPV-negative HNSCC as a distinct clinical indication within head and neck cancer - one with particularly poor outcomes, limited therapeutic options, and that represents the vast majority of patients. BTD was supported by results from multiple Phase 1/1b dose cohorts evaluating ficerafusp alfa In combination with pembrolizUMab in patients with 1L HPV-negative R/M HNSCC. Data most recently presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrated deep and durable clinical benefit with a median duration of response of 21.7 months, and a median overall survival of 21.3 months, alongside a favorable safety and tolerability profile. BTD is intended to expedite the development and review of potential new medicines that show substantial improvement over available therapies for serious or life-threatening conditions, providing greater interaction with the FDA, involvement of senior agency leadership, and eligibility for rolling and priority review.
分析記事 • Jul 15We're Not Very Worried About Bicara Therapeutics' (NASDAQ:BCAX) Cash Burn RateWe can readily understand why investors are attracted to unprofitable companies. For example, although Amazon.com made...
お知らせ • Jun 02Bicara Therapeutics Inc. Demonstrates Deep and Durable Responses with Ficerafusp Alfa Plus Pembrolizumab in 1L HPV-Negative R/M HNSCC at ASCO 2025Bicara 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. Ficerafusp alfa is a first-in-class bifunctional antibody designed to enhance tumor penetration by breaking barriers in the tumor microenvironment that have challenged the treatment of multiple solid tumor cancers. Specifically, ficerafusp alfa combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-ß). In the Phase 1/1b trial, ficerafusp alfa in combination with pembrolizumab resulted in deep and durable anti-tumor activity with improved overall survival (OS) compared to historical benchmarks in patients with 1L R/M human papillomavirus (HPV)-negative HNSCC with a PD-L1 combined positive score (CPS) of =1 and with at least 24 months of follow-up. In the efficacy evaluable human papillomavirus (HPV)-negative population (n=28): Median duration of response (DOR) of 21.7 months amongst responders (n=15). Median OS of 21.3 months; 2-year OS rate of 46%. 54% (15/28) confirmed objective response rate (ORR); 64% (18/28) ORR, including an additional three unconfirmed responses. 21% (6/28) complete response rate. 80% (12/15) of responders achieved a deep response (=80% tumor shrinkage). Disease control rate of 89% (25/28 patients). Median progression-free survival of 9.9 months. Manageable safety profile consistent with previously reported adverse events.
お知らせ • Apr 29Bicara Therapeutics Inc. Highlights Broad Potential of Ficerafusp Alfa at AACR Annual Meeting 2025Bicara Therapeutics Inc. announced multiple presentations related to ficerafusp alfa at the American Association for Cancer Research (AACR) Annual Meeting 2025. Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-b) and is being evaluated across multiple solid tumor types.
お知らせ • Apr 28Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2025Bicara Therapeutics Inc., Annual General Meeting, Jun 09, 2025.
お知らせ • Apr 23Bicara Therapeutics to Present Updated Data from Ongoing Phase 1/1B Trial of Ficerafusp Alfa in 1L R/M HNSCC At the 2025 American Society of Clinical Oncology Annual MeetingBicara Therapeutics Inc. announced that updated data from the company's ongoing Phase 1/1b clinical trial of ficerafusp alfa in 1L (first line) recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) will be highlighted in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from May 30-June 3, 2025 in Chicago, IL. Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets: an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-b) and is being evaluated across multiple solid tumor types. Ficerafusp alf is a first-in- class bifunctional antibody that combine two clinically validated targets, an epidermal growth factor receptors (EGFR) directed monOClonal antibody with a domain That binds to human transforming growth factor Beta (TGF-b). Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-b signaling within the tumor microenvironment. Ficerafusp alFA is currently being evaluated in FORTIFI-HN01, a pivotal Phase 2/3 clinical trial 1L (first line)urrent/metastatic (R-M) head and neck squ Famous cell carcinoma (H NSCC).
Seeking Alpha • Apr 19Bicara: Innovative Precision Tumor TargetingSummary Bicara Therapeutics' lead candidate, ficerafusp alfa, targets EGFR and TGF-beta in tumors, showing promise in hard-to-treat cancers like Head and Neck Squamous Cell Carcinoma. Bicara's financial health is robust, with $489.7 million in cash, ensuring operations through mid-2029, bolstered by a successful IPO and Series C funding. Early clinical data for ficerafusp alfa plus pembrolizumab in HPV-negative HNSCC shows significant antitumor activity and manageable safety, supporting its potential market impact. Bicara's pivotal Phase 2/3 trial could establish ficerafusp alfa as a new standard of care, with a potential market revenue of $1.3 billion annually. Read the full article on Seeking Alpha
分析記事 • Mar 13We Think Bicara Therapeutics (NASDAQ:BCAX) Can Afford To Drive Business GrowthJust because a business does not make any money, does not mean that the stock will go down. For example, although...
お知らせ • Feb 13Bicara Therapeutics Announces First Patients Enrolled in FORTIFI-HN01, a Pivotal Phase 2/3 Clinical Trial of Ficerafusp Alfa in 1L Recurrent/Metastatic Head and Neck Squamous Cell CarcinomaBicara 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). Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-ß). FORTIFI-HN01 is a global, randomized, double-blinded, placebo-controlled, pivotal Phase 2/3 trial that aims to enroll approximately 650 R/M HNSCC patients, excluding patients with human papillomavirus (HPV)-positive with oropharyngeal squamous cell carcinoma. Patients enrolled in the trial must have a PD-L1 CPS greater than or equal to one, and not have received systemic therapy in the R/M setting. The primary endpoints are overall response rate based on RECIST v1.1 and overall survival, with results potentially supporting filings for both accelerated approval and full approval. Secondary endpoints include progression free survival and duration of response.
Seeking Alpha • Feb 02Bicara Therapeutics: A Decline Off The IPO Spells 'Wait' For MeSummary Bicara Therapeutics is a new biotech firm focusing on innovative cancer treatments, currently advancing its lead candidate, ficerafusp alfa, targeting challenging cancers like HNSCC. BCAX's financial health is strong, with sufficient capital to fund operations for about four years, but relies heavily on the success of ficerafusp alfa. Early trial results for ficerafusp alfa show promise, particularly in HPV-negative HNSCC, but the lack of diverse pipeline and early-stage data pose significant risks. Given the long wait for potential approval and high volatility, BCAX is a speculative investment better suited for patient, risk-tolerant investors, and I would personally watch for a favorable entry point. Read the full article on Seeking Alpha
お知らせ • Jan 28Bicara Therapeutics Presents Phase 1/1B Dose Expansion Results with Ficerafusp Alfa in Advanced Squamous Cancer of the Anal Canal At the 2025 Asco Gastrointestinal Cancers SymposiumBicara 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). The results were presented in a poster session during the 2025 ASCO Gastrointestinal (GI) Cancers Symposium on Saturday, January 25, 2025. Ficerafusp alfa is a first-in-class bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor (EGFR) directed monoclonal antibody with a domain that binds to human transforming growth factor beta (TGF-b), and is being evaluated in multiple solid tumor types. The addition of ficeraf Susp alfa shows the potential to improve efficacy compared to historical data with pembrolizumib monotherapy in SCAC, with increased overall response rate, disease control rate, and 12-month progression-free survival, indicative of improved speed, depth, and durability of response. Importantly, responses were observed even in patients with liver metastases, which is a significant outcome in this setting. Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF-b signaling within the tumor microenvironment.
お知らせ • Sep 14Bicara Therapeutics Inc. has completed an IPO in the amount of $315 million.Bicara Therapeutics Inc. has completed an IPO in the amount of $315 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 17,500,000 Price\Range: $18 Discount Per Security: $1.26 Transaction Features: Reserved Share Offering; Sponsor Backed Offering
