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北京时间·🕒 发布 19:30:00时区推断·⟳ 抓取 19:32:58回填·⚡ 决策 07-20 19:35:14·99.0 天前
Biohaven宣布BHV-1530将在ESMO披露更新数据，并与Regeneron开展cemiplimab联合用药供药合作
BHV-1530的FGFR3 ADC早期活性和安全性方向偏正面，但本次公告主要是ESMO预告和临床供药合作，关键有效性数据要到2026-10-23才披露。
📄 原文BHVN↗ 原文
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不做 Biohaven（BHVN.US）
方向偏正面但本次只是ESMO数据预告+临床供药合作，核心早期活性5月已披露，盘前已涨约9%；缺少新增ORR/样本数/剂量等硬数据，追高edge不足，不做。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
消息传播链
- Biohaven已在R&D Day披露BHV-1530无DLT、无FGFR类毒性、早期肿瘤缩小和后续POC/扩展数据预期，说明本次公告的核心医学叙事并非全新。
- Biohaven官方宣布BHV-1530将在ESMO 2026展示Phase 1更新数据，并与Regeneron签署cemiplimab联合用药临床供药协议。市场反应:BHVN.US盘前/最新价15.44美元，较前收14.17美元上涨8.96%。
关键理由
- BHV-1530的FGFR3 ADC早期活性和安全性方向偏正面，但本次公告主要是ESMO预告和临床供药合作，关键有效性数据要到2026-10-23才披露。
- 公司在2026-05-27 R&D Day已经披露无DLT、无FGFR类毒性、早期肿瘤缩小等核心信息，本次新增信息更像临床进展确认而非完整数据读出。
- Biohaven（BHVN.US）盘前已涨约8.96%，在缺少ORR、样本数、剂量层级和持续缓解等硬数据前，追高的正期望不足。
主要风险
- 若ESMO摘要或会前数据随后披露出更高ORR/确认PR数量，BHVN可能继续重定价，需要由新信号重新评估。
- 当前为临床阶段公司，BHV-1530仍处Phase 1剂量递增，样本小且未披露商业化时间表，临床失败或数据不及预期风险高。
反向证据
- 做多前查反向 · 来源 kb_search · 日期 2026-05-27 · 影响 weakens
内部库未见新的硬性反证，但SEC/R&D Day旧材料显示核心早期活性叙事已提前披露，削弱本次作为新催化的边际强度。
检索:Biohaven BHV-1530 FGFR3 ADC May 27 2026 R&D Day Phase 1 Regeneron cemiplimab 原文 ↗
工具调用 · 历史记录,结果未知(3 种)
- search_processed_events · 结果未知
- stock_quote · 结果未知
- kb_search · 结果未知
原文全文
展开原文 · 8,000 字
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Gaurav Munj
2022-03-04T06:42:16+00:00
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July 20, 2026 at 7:30 AM EDT
Biohaven to Present New Clinical Data at ESMO Congress on BHV-1530, a Novel FGFR3-Directed ADC With a Proprietary Topoisomerase I (TopoIx) Payload
PDF Version
Biohaven also announces new clinical supply agreement with Regeneron to evaluate BHV-1530 in combination with cemiplimab (Libtayo®)
Early clinical activity observed: Phase 1 dose-escalation data show early tumor reductions in patients with Fibroblast Growth Factor Receptor (FGFR)3-altered and wild-type overexpressing tumors. Signal activity including confirmed partial responses in heavily pretreated patients in multiple tumor types.
Differentiated safety profile: No dose-limiting toxicities and no FGFR inhibitor-class toxicities observed, supporting a potentially broader therapeutic index than approved FGFR tyrosine kinase inhibitors (TKIs).
Potential to expand the addressable FGFR3 population: Unlike FGFR TKIs, which are restricted to the ~15–20% of metastatic urothelial cancer patients with FGFR3 alterations, BHV-1530 is designed to target FGFR3 regardless of alteration status, including wild-type overexpression seen in approximately 50% of metastatic urothelial cancer cases as well as other tumor types that overexpress FGFR3.
Anti-PD-1 combination cohorts planned: Biohaven has entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate BHV-1530 in combination with cemiplimab (Libtayo), building on preclinical data demonstrating synergistic activity between BHV-1530's TopoIx payload and immune checkpoint blockade.
NEW HAVEN, Conn. , July 20, 2026 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (" Biohaven "), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced that new data on BHV-1530, its FGFR3-directed antibody-drug conjugate (ADC) using a novel topoisomerase I (TopoIx) payload, will be presented at the European Society for Medical Oncology (ESMO) Congress 2026, to be held October 23-27 in Madrid, Spain .
1019P - Phase 1 study of BHV-1530, a first-in-class FGFR3 ADC in Advanced Tumors
October 23, 2026 : 15:15 - 16:00
The new Phase 1 data planned for ESMO will provide a clinically meaningful update to the early Phase 1 data initially disclosed at Biohaven's R&D Day on May 27, 2026 . The new data will include signals of clinical activity demonstrated in the ongoing Phase 1, open-label, dose-escalation study of BHV-1530 in patients with advanced solid tumors. The data from May 27 2026 , showed early signs of antitumor activity in patients with both FGFR3-altered and wild-type overexpressing tumors, and across multiple tumor types. This included a heavily pretreated patient with FGFR3-TACC3 fusion–positive metastatic urothelial cancer who had progressed on four prior lines of therapy, including Padcev (a nectin-4-directed ADC), pembrolizumab, and two FGFR-targeting small molecules. This patient has tolerated BHV-1530 with no FGFR-related toxicity. The data has shown a favorable safety profile, with no dose-limiting toxicities and no FGFR inhibitor–class toxicities, such as hyperphosphatemia, nail disorders, stomatitis, or retinopathy, that commonly constrain dosing and duration of approved FGFR tyrosine kinase inhibitors.
Clinical Supply Agreement with Regeneron for BHV-1530 and Cemiplimab
Biohaven has entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate the combination of BHV-1530 and cemiplimab (Libtayo) in patients with solid tumors based upon the emerging monotherapy clinical data and preclinical data demonstrating synergistic activity between BHV-1530 and immune therapy. BHV-1530's TopoIx payload has been demonstrated to generate immunogenic cell death and stimulate an antitumor immune response, providing a compelling mechanistic rationale for combination with checkpoint inhibition.
This agreement builds upon the existing clinical supply agreement between Biohaven and Regeneron for BHV-1510, a next-generation TROP2-directed ADC, further deepening the collaborative relationship between the two companies across Biohaven's oncology pipeline. Of note, early clinical data from the BHV-1510 program demonstrate a signal consistent with this thesis, as responses have been observed in multiple patients with prior anti–PD-(L)1 therapy.
About BHV-1530
BHV-1530 is an antibody-drug conjugate directed against FGFR3, a validated but underexploited target in urothelial cancer and other FGFR3-driven cancers, and is a first in clinic FGFR3-directed ADC incorporating Biohaven's proprietary TopoIx payload. Unlike approved FGFR tyrosine kinase inhibitors, which are restricted to genomically selected patients and constrained by class-related toxicities, BHV-1530 is designed to target FGFR3 independent of requiring pathway inhibition, with the potential to address both FGFR3-altered and wild-type overexpressing tumors. BHV-1530 is being studied in an ongoing Phase 1 dose-escalation trial in unselected patients with advanced urothelial cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer who have failed standard-of-care therapy, as well as other tumor types harboring FGFR3 genomic alterations. Biohaven plans to initiate combination cohorts evaluating BHV-1530 with anti-PD-1 therapy, including the recently announced combination with cemiplimab (Libtayo), in the second half of 2026.
About Biohaven
Biohaven Ltd. (NYSE: BHVN) is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; and myostatin inhibition for neuromuscular and metabolic diseases, including obesity. For more information, visit www.biohaven.com .
Forward-Looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing, conduct, and outcomes of Biohaven's ongoing and planned clinical trials of BHV-1530, including the planned combination with cemiplimab under the clinical supply agreement with Regen
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Overview
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Board of Directors
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Global Collaboration
Innovation
Pipeline
Innovation Engine
Clinical Trials at Biohaven
Publications
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In The News
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Investors
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Events and Presentations
Upcoming and Recent Events
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SEC Filings
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Governance Documents
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Contact
Commitment
Overview
Early Access Program
Careers
Overview
#BeBiohaven
Contact
Gaurav Munj
2022-03-04T06:42:16+00:00
Press Release Details
Upcoming and Recent Events
Corporate Presentation
SEC Filings
Stock Quote & Chart
Historical Lookup
Governance Documents
Committees
July 20, 2026 at 7:30 AM EDT
Biohaven to Present New Clinical Data at ESMO Congress on BHV-1530, a Novel FGFR3-Directed ADC With a Proprietary Topoisomerase I (TopoIx) Payload
PDF Version
Biohaven also announces new clinical supply agreement with Regeneron to evaluate BHV-1530 in combination with cemiplimab (Libtayo®)
Early clinical activity observed: Phase 1 dose-escalation data show early tumor reductions in patients with Fibroblast Growth Factor Receptor (FGFR)3-altered and wild-type overexpressing tumors. Signal activity including confirmed partial responses in heavily pretreated patients in multiple tumor types.
Differentiated safety profile: No dose-limiting toxicities and no FGFR inhibitor-class toxicities observed, supporting a potentially broader therapeutic index than approved FGFR tyrosine kinase inhibitors (TKIs).
Potential to expand the addressable FGFR3 population: Unlike FGFR TKIs, which are restricted to the ~15–20% of metastatic urothelial cancer patients with FGFR3 alterations, BHV-1530 is designed to target FGFR3 regardless of alteration status, including wild-type overexpression seen in approximately 50% of metastatic urothelial cancer cases as well as other tumor types that overexpress FGFR3.
Anti-PD-1 combination cohorts planned: Biohaven has entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate BHV-1530 in combination with cemiplimab (Libtayo), building on preclinical data demonstrating synergistic activity between BHV-1530's TopoIx payload and immune checkpoint blockade.
NEW HAVEN, Conn. , July 20, 2026 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (" Biohaven "), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced that new data on BHV-1530, its FGFR3-directed antibody-drug conjugate (ADC) using a novel topoisomerase I (TopoIx) payload, will be presented at the European Society for Medical Oncology (ESMO) Congress 2026, to be held October 23-27 in Madrid, Spain .
1019P - Phase 1 study of BHV-1530, a first-in-class FGFR3 ADC in Advanced Tumors
October 23, 2026 : 15:15 - 16:00
The new Phase 1 data planned for ESMO will provide a clinically meaningful update to the early Phase 1 data initially disclosed at Biohaven's R&D Day on May 27, 2026 . The new data will include signals of clinical activity demonstrated in the ongoing Phase 1, open-label, dose-escalation study of BHV-1530 in patients with advanced solid tumors. The data from May 27 2026 , showed early signs of antitumor activity in patients with both FGFR3-altered and wild-type overexpressing tumors, and across multiple tumor types. This included a heavily pretreated patient with FGFR3-TACC3 fusion–positive metastatic urothelial cancer who had progressed on four prior lines of therapy, including Padcev (a nectin-4-directed ADC), pembrolizumab, and two FGFR-targeting small molecules. This patient has tolerated BHV-1530 with no FGFR-related toxicity. The data has shown a favorable safety profile, with no dose-limiting toxicities and no FGFR inhibitor–class toxicities, such as hyperphosphatemia, nail disorders, stomatitis, or retinopathy, that commonly constrain dosing and duration of approved FGFR tyrosine kinase inhibitors.
Clinical Supply Agreement with Regeneron for BHV-1530 and Cemiplimab
Biohaven has entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate the combination of BHV-1530 and cemiplimab (Libtayo) in patients with solid tumors based upon the emerging monotherapy clinical data and preclinical data demonstrating synergistic activity between BHV-1530 and immune therapy. BHV-1530's TopoIx payload has been demonstrated to generate immunogenic cell death and stimulate an antitumor immune response, providing a compelling mechanistic rationale for combination with checkpoint inhibition.
This agreement builds upon the existing clinical supply agreement between Biohaven and Regeneron for BHV-1510, a next-generation TROP2-directed ADC, further deepening the collaborative relationship between the two companies across Biohaven's oncology pipeline. Of note, early clinical data from the BHV-1510 program demonstrate a signal consistent with this thesis, as responses have been observed in multiple patients with prior anti–PD-(L)1 therapy.
About BHV-1530
BHV-1530 is an antibody-drug conjugate directed against FGFR3, a validated but underexploited target in urothelial cancer and other FGFR3-driven cancers, and is a first in clinic FGFR3-directed ADC incorporating Biohaven's proprietary TopoIx payload. Unlike approved FGFR tyrosine kinase inhibitors, which are restricted to genomically selected patients and constrained by class-related toxicities, BHV-1530 is designed to target FGFR3 independent of requiring pathway inhibition, with the potential to address both FGFR3-altered and wild-type overexpressing tumors. BHV-1530 is being studied in an ongoing Phase 1 dose-escalation trial in unselected patients with advanced urothelial cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer who have failed standard-of-care therapy, as well as other tumor types harboring FGFR3 genomic alterations. Biohaven plans to initiate combination cohorts evaluating BHV-1530 with anti-PD-1 therapy, including the recently announced combination with cemiplimab (Libtayo), in the second half of 2026.
About Biohaven
Biohaven Ltd. (NYSE: BHVN) is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; and myostatin inhibition for neuromuscular and metabolic diseases, including obesity. For more information, visit www.biohaven.com .
Forward-Looking Statements
This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing, conduct, and outcomes of Biohaven's ongoing and planned clinical trials of BHV-1530, including the planned combination with cemiplimab under the clinical supply agreement with Regen
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