Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
ONC Catalyst Timeline
Dated clinical, regulatory and corporate events for BeOne Medicines Ltd.
Catalyst Timeline
Dated clinical, regulatory & corporate events for BeOne Medicines Ltd.
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How ONC actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-08-25 | Tevimbra (tislelizumab-jsgr) | PDUFA Date Approved | PDUFA |
Drug Pipeline Intelligence
| Product | Revenue | Prior period | Change |
|---|---|---|---|
| BRUKINSA | |||
| TEVIMBRA | |||
| XGEVA | |||
| BLINCYTO | |||
| KYPROLIS | |||
| POBEVCY |
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| BGB-43395 Small moleculeNCT07492641 | HR+/HER2- Breast Cancer | Phase 3 | RECRUITING | 1,056 | Aug 7, 2037 | ||||||
| BGB-A445 Small moleculeNCT05661955 | Urothelial Carcinoma | Phase 1 | ACTIVE NOT_RECRUITING | 113 | Oct 1, 2026 | ||||||
| Tislelizumab Monoclonal antibodyMarketedNCT06091943 | Non Small Cell Lung Cancer | Phase 3 | ACTIVE NOT_RECRUITING | 2,575 | Jul 31, 2026 | ||||||
| Tislelizumab Monoclonal antibodyMarketedNCT07715396 | Non-small Cell Lung Cancer Metastatic | Phase 3 | NOT YET_RECRUITING | 230 | Oct 30, 2031 | ||||||
| Tislelizumab Monoclonal antibodyNCT03967977 | Urothelial Carcinoma | Phase 3 | ACTIVE NOT_RECRUITING | 420 | Oct 21, 2027 | ||||||
| Tislelizumab Monoclonal antibodyMarketedNCT07043400 | Metastatic Gastric Adenocarcinoma | Phase 3 | RECRUITING | 351 | Apr 22, 2028 | ||||||
| Tislelizumab Monoclonal antibodyNCT05909904 | Head and Neck Squamous Cell Carcinoma | Phase 2 | ACTIVE NOT_RECRUITING | 160 | May 28, 2026 | ||||||
| Tislelizumab Monoclonal antibodyNCT03736889 | MSI-H/dMMR Solid Tumors | Phase 2 | RECRUITING | 200 | Sep 1, 2027 | ||||||
| Tislelizumab Monoclonal antibodyMarketedNCT07290985 | Gastroesophageal Adenocarcinoma | Phase 2 | RECRUITING | 242 | Dec 1, 2028 | ||||||
| Tislelizumab Monoclonal antibodyMarketedNCT07733180 | Advanced Esophageal Squamous Cell Carcinoma | Phase 2 | RECRUITING | 30 | Feb 28, 2028 | ||||||
| Tislelizumab Monoclonal antibodyMarketedNCT07554521 | Advanced Unresectable Gastric Adenocarcinoma | Phase 2 | RECRUITING | 30 | Dec 31, 2031 | ||||||
| Sonrotoclax Small moleculeNCT06073821 | CLL | Phase 3 | ACTIVE NOT_RECRUITING | 652 | Dec 1, 2032 | ||||||
| Tacabrutideg Small moleculeNCT06846671 | CLL | Phase 3 | RECRUITING | 250 | Feb 14, 2030 | ||||||
| Tacabrutideg Small moleculeNCT06970743 | Chronic Lymphocytic Leukemia | Phase 3 | ACTIVE NOT_RECRUITING | 653 | Nov 30, 2029 | ||||||
| Sonrotoclax Small moleculeNCT06637501 | Chronic Lymphocytic Leukemia | Phase 3 | ACTIVE NOT_RECRUITING | 1,482 | Sep 1, 2029 | ||||||
| Sonrotoclax Small moleculeMarketedNCT05471843 | Mantle Cell Lymphoma | Phase 3 | ACTIVE NOT_RECRUITING | 425 | Jan 31, 2027 | ||||||
| Sonrotoclax Small moleculeNCT05479994 | Leukemia | Phase 2 | ACTIVE NOT_RECRUITING | 100 | Aug 25, 2027 | ||||||
| Sonrotoclax Small moleculeNCT05952037 | Waldenstrom Macroglobulinemia | Phase 2 | ACTIVE NOT_RECRUITING | 114 | Aug 1, 2028 | ||||||
| Tacabrutideg Small moleculeNCT07005713 | Chronic Spontaneous Urticaria | Phase 1 | RECRUITING | 58 | Nov 30, 2026 | ||||||
| Sonrotoclax Small moleculeMarketedNCT04883957 | Mature B-cell Malignancies | Phase 1 | ACTIVE NOT_RECRUITING | 501 | Jun 1, 2026 | ||||||
| Sonrotoclax Small moleculeNCT06497062 | Acute Myeloid Leukemia | Phase 1 | ACTIVE NOT_RECRUITING | 307 | Jun 30, 2028 | ||||||
| Sonrotoclax Small moleculeNCT07770698 | Relapsed Acute Myeloid Leukemia | Phase 1 | NOT YET_RECRUITING | 30 | Sep 1, 2031 | ||||||
| Sonrotoclax Small moleculeNCT04973605 | Relapsed/Refractory Multiple Myeloma | Phase 1 | RECRUITING | 246 | Nov 1, 2026 | ||||||
| Tacabrutideg Small moleculeNCT06634589 | B-cell Malignancy | Phase 1 | RECRUITING | 915 | Dec 2, 2029 | ||||||
| BG-C9074 Small moleculeNCT07811271 | Epithelial Ovarian Cancer | Phase 3 | NOT YET_RECRUITING | 600 | Mar 31, 2033 |
Clinical Trial Results
Readouts, endpoints and source filings for every ONC program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| ZIIHERA | HER2+ gastroesophageal adenocarcinoma | Phase 3 | 2026-08-31 | statistically significant overall survival benefitRead More | BeOne Medicines Announces New Phase 3 Survival Data Reinforcing Benefit of ZIIHERA-Containing Regimens in First-Line HER2+ Gastroesophageal CancerRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Lee Chan HenryOfficer (SVP, General Counsel) | Sell | -1,115 | $375.00 | 09/30/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in ONC
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| BAKER BROS. ADVISORS | 12.6 % (-16 %) | 2.51 B | 8.80 M | 0.03% ( 2.51 K) |
ONC Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-10-16 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How ONC ranks across every disease it competes in
ONC News
BeOne Medicines anuncia acordo voluntário com o governo dos EUA para expandir o acesso a medicamentos inovadores contra o câncer
BeOne Medicines has announced a voluntary agreement with the U.S. government aimed at expanding access to innovative cancer treatments for American patients. This agreement not only enhances patient access but also strengthens BeOne's manufacturing capabilities in the U.S. and supports large-scale drug provision.
Read more →BeOne Medicines anuncia un acuerdo voluntario con el Gobierno de EE. UU. para ampliar el acceso a medicamentos innovadores contra el cáncer
BeOne Medicines has announced a voluntary agreement with the U.S. government aimed at increasing patient access to innovative cancer treatments. This agreement will bolster the company's production capabilities within the United States, allowing for enhanced large-scale manufacturing of its drugs. The initiative reflects BeOne's commitment to improving cancer care for American patients.
Read more →Riassunto: BeOne Medicines annuncia un accordo volontario con l'Amministrazione degli Stati Uniti per ampliare l'accesso a farmaci oncologici innovativi
BeOne Medicines has announced a voluntary agreement with the U.S. Administration to enhance access to innovative oncology drugs for American patients. This agreement also aims to strengthen the company's production presence in the U.S. and expand the necessary capabilities for large-scale drug supply.
Read more →BeOne Medicines gibt freiwillige Vereinbarung mit der US-Regierung bekannt, um den Zugang zu innovativen Krebsmedikamenten zu erweitern
BeOne Medicines has announced a voluntary agreement with the US government to enhance access to innovative cancer medications for American patients. This initiative also aims to strengthen the company's production presence in the USA and expand its capabilities for large-scale drug provision. The agreement reflects a commitment to improving healthcare access.
Read more →Samenvatting: BeOne Medicines kondigt vrijwillige overeenkomst met Amerikaanse overheid aan om toegang tot innovatieve kankermedicijnen te vergroten
BeOne Medicines has announced a voluntary agreement with the U.S. government aimed at enhancing access to innovative cancer treatments for American patients. This initiative not only focuses on improving patient access but also aims to strengthen U.S. manufacturing capabilities and expand the large-scale delivery of medications.
Read more →BeOne Medicines to Present at the Morgan Stanley Annual Global Healthcare Conference
BeOne Medicines Ltd. will present at the Morgan Stanley Annual Global Healthcare Conference on September 14, 2026. The company will participate in a fireside chat scheduled for 11:30 a.m. EDT. Investors can access a live webcast of the event through the company's website, with an archived version also available.
Read more →BeOne Medicines Announces Voluntary Agreement with U.S. Government to Expand Access to Innovative Cancer Medicines
BeOne Medicines has entered a voluntary agreement with the U.S. Government to enhance access to innovative cancer treatments for American patients. This initiative also aims to bolster BeOne's manufacturing capabilities in the U.S., ensuring the delivery of medicines at scale. The agreement reflects the company's dedication to patient access and ongoing investment in research.
Read more →BeOne Medicines gibt neue Überlebensdaten aus Phase-3-Studien bekannt, die den Nutzen von ZIIHERA-haltigen Therapien bei HER2-positivem gastroösophagealem Krebs in der Erstlinienbehandlung untermauern
BeOne Medicines announced positive topline results from the second interim analysis of the Phase 3 HERIZON-GEA-01 study. The study evaluates ZIIHERA (Zanidatamab) combined with chemotherapy, with or without TEVIMBRA (Tislelizumab), for treating HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma. These findings support the drug's potential as a first-line treatment.
Read more →Samenvatting: BeOne Medicines kondigt nieuwe overlevingsgegevens uit Fase 3-studie aan die het voordeel bevestigen van behandelregimes met ZIIHERA bij eerstelijnsbehandeling van HER2-positieve gastro-oesofageale kanker
BeOne Medicines announced positive interim results from the Phase 3 HERIZON-GEA-01 study. The study evaluated ZIIHERA in combination with chemotherapy, with or without TEVIMBRA, for first-line treatment of HER2-positive gastro-esophageal cancer. These results confirm the treatment's benefits for patients with advanced or metastatic disease.
Read more →Riassunto: BeOne Medicines annuncia i nuovi dati sulla sopravvivenza di Fase 3 a supporto del beneficio dei regimi a base di ZIIHERA nel trattamento di prima linea dei tumori gastroesofagei (GEA) HER2-positivi
BeOne Medicines announced positive preliminary results from the Phase 3 HERIZON-GEA-01 study. The trial evaluates ZIIHERA (zanidatamab) combined with chemotherapy, with or without TEVIMBRA (tislelizumab), for first-line treatment of locally advanced HER2-positive gastroesophageal adenocarcinoma. These results support the potential benefits of ZIIHERA in this patient population.
Read more →BeOne Medicines Announces New Phase 3 Survival Data Reinforcing Benefit of ZIIHERA-Containing Regimens in First-Line HER2+ Gastroesophageal Cancer
BeOne Medicines has reported positive topline results from the second interim analysis of the Phase 3 HERIZON-GEA-01 trial. The trial evaluates ZIIHERA in combination with chemotherapy for treating HER2+ gastroesophageal adenocarcinoma. The findings reinforce the benefit of ZIIHERA-containing regimens as a first-line treatment option.
Read more →Riassunto: BeOne Medicines annuncia l'approvazione da parte dell'FDA statunitense del regime a base di TEVIMBRA per il trattamento di prima linea dell'adenocarcinoma gastroesofageo (GEA) HER2-positivo
BeOne Medicines has received FDA approval for TEVIMBRA, a treatment for HER2-positive gastroesophageal adenocarcinoma. This approval allows TEVIMBRA to be used in combination with ZIIHERA and chemotherapy for adult patients. The approval marks a significant advancement in the treatment options available for this patient population.
Read more →Samenvatting: BeOne Medicines kondigt goedkeuring door Amerikaanse FDA aan voor een op TEVIMBRA gebaseerd behandelregime bij eerstelijnsbehandeling van HER2+ GEA
BeOne Medicines has received FDA approval for a supplemental biologics license application for TEVIMBRA (tislelizumab) in combination with ZIIHERA (zanidatamab) and chemotherapy. This approval is specifically for the first-line treatment of adult patients with unresectable HER2+ gastric or gastroesophageal junction adenocarcinoma. This marks a significant advancement in treatment options for this patient population.
Read more →BeOne Medicines gibt die Zulassung durch die US-amerikanische FDA für eine auf TEVIMBRA basierende Therapie zur Erstlinienbehandlung von HER2-positiver GEA bekannt
BeOne Medicines has announced that the FDA has approved a supplemental biologics license application for TEVIMBRA (Tislelizumab) in combination with ZIIHERA (Zanidatamab) and chemotherapy. This therapy is intended for first-line treatment of adult patients with inoperable, locally advanced, or metastatic HER2-positive gastric cancer. This approval represents a significant advancement in treatment options for this patient population.
Read more →BeOne Medicines Announces U.S. FDA Approval for TEVIMBRA-Based Regimen for First-Line HER2+ GEA
BeOne Medicines has received FDA approval for its TEVIMBRA-based regimen, which includes ZIIHERA and chemotherapy, aimed at treating adult patients with unresectable locally advanced or metastatic HER2-positive gastric and gastroesophageal junction cancer. This approval marks a significant advancement in the treatment options available for this patient population.
Read more →Samenvatting: BeOne Medicines, BeOne Care Foundation en The Max Foundation verlengen samenwerking om toegang tot BRUKINSA® voor de behandeling van chronische lymfatische leukemie in lage- en middeninkomenslanden te vergroten
BeOne Medicines, along with the BeOne Care Foundation and The Max Foundation, has announced the extension of their collaboration until 2028. This partnership aims to enhance access to BRUKINSA® (zanubrutinib) for treating chronic lymphocytic leukemia in low- and middle-income countries. The initiative reflects a commitment to improving healthcare accessibility.
Read more →Riassunto: BeOne Medicines, BeOne Care Foundation e The Max Foundation rinnovano la collaborazione per ampliare l'accesso a BRUKINSA® per il trattamento della leucemia linfatica cronica nei Paesi a reddito medio-basso
BeOne Medicines, in partnership with the BeOne Care Foundation and The Max Foundation, has renewed its collaboration until 2028 to enhance access to BRUKINSA® for chronic lymphocytic leukemia treatment. This initiative targets low-to-middle-income countries, aiming to improve healthcare outcomes in these regions.
Read more →BeOne Medicines, BeOne Care Foundation, and The Max Foundation Renew Partnership to Expand Access to BRUKINSA® for the Treatment of Chronic Lymphocytic Leukemia in Low- and Middle-Income Countries
BeOne Medicines, in collaboration with the BeOne Care Foundation and The Max Foundation, has renewed their partnership until 2028. This initiative aims to improve access to BRUKINSA® for patients with chronic lymphocytic leukemia in low- and middle-income countries. The partnership emphasizes the importance of addressing healthcare inequalities in cancer treatment.
Read more →Samenvatting: BeOne Medicines en Revolution Medicines kondigen samenwerking aan voor klinische ontwikkeling en regionale commercialisering
BeOne Medicines and Revolution Medicines have announced a multi-faceted collaboration aimed at advancing clinical development and regional commercialization of targeted therapies for RAS-dependent cancers. This partnership combines the strengths of both companies to enhance their capabilities in oncology. The collaboration is expected to accelerate the development of innovative treatment options.
Read more →BeOne Medicines und Revolution Medicines kündigen Zusammenarbeit bei klinischer Entwicklung und regionaler Vermarktung an
BeOne Medicines and Revolution Medicines have announced a multi-faceted collaboration aimed at advancing clinical development and regional marketing of targeted therapies for RAS-dependent cancers. This partnership leverages the strengths of both companies in oncology, potentially benefiting patients with these specific cancer types.
Read more →