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BeOne Medicines Ltd.

ONCFDA catalysts, PDUFA dates & pipeline intelligence
$351.48
▲ +2.4 · +0.69%

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52W LOW $253.9552W HIGH $385.22
Volume
361.61 K
Value Traded
298.03 M
Short % Float
1.86%
+0.39%Week
+1.44%1 Month
+10.73%3 Month
+9.6%6 Month
-9.94%5 Year
+970.94%All Time

Cash Data

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Key Stats

Market Cap
38.59 B
EPS (TTM)
5.80
P/E Ratio
60.64
Ent. Value
34.47 B
Total Shares
109.72 M
Float Shares
103.72 M
Insiders
0.53%
Institutions
33.33%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Phase 3 data presentation
ZIIHERA (zanidatamab) with chemotherapy; TEVIMBRA (tislelizumab) with ZIIHERA and chemotherapy
First-line unresectable locally advanced or metastatic HER2+ gastroesophageal adenocarcinoma (GEA)
Priority
Phase 3BiologicsOncology
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

ONC Catalyst Timeline

Dated clinical, regulatory and corporate events for BeOne Medicines Ltd.

Catalyst Timeline

Dated clinical, regulatory & corporate events for BeOne Medicines Ltd.

845Total events
26Upcoming
405Tier-1 (high impact)
2018 to 2029Coverage

Upcoming catalysts 2

T1NDA Submission
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Tacabrutideg
T2Trial Initiation
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BG-C9074

Event history 50

▲Interim AnalysisZIIHERAApprovedTrial
Positive interim analysis 2 results from HERIZON-GEA-01
HER2-positive gastroesophageal adenocarcinoma (GEA)source ↗
▲Interim AnalysisZIIHERAApprovedTrial
Positive preliminary results from second interim analysis (IA2) of HERIZON-GEA-01
HER2-positive gastroesophageal adenocarcinoma (GEA)source ↗
▲Topline ReadoutZIIHERAApprovedClinical Data
ZIIHERA plus chemotherapy met OS endpoint at IA2
HER2+ gastroesophageal adenocarcinomasource ↗
▲Primary Endpoint MetZIIHERAApprovedClinical Data
ZIIHERA plus chemo met remaining primary endpoint OS at IA2
HER2+ gastroesophageal adenocarcinomasource ↗
▲Partnership / LicenseCorporate
Voluntary agreement with U.S. Government to expand access to cancer medicines
▲Manufacturing MilestoneCMC / Inspection
$300 million onshoring investment in Hopewell, NJ facility
▲Supplemental ApprovalTEVIMBRAApprovedFDA Decision
FDA approval of TEVIMBRA-based therapy for first-line HER2-positive GEA
HER2-positive GEAsource ↗
▲Priority ReviewTEVIMBRAApprovedRegulatory Filing
FDA granted Priority Review to sBLA for TEVIMBRA in combination with ZIIHERA and chemotherapy
first-line treatment of unresectable locally advanced/metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinomasource ↗
▲Breakthrough Therapy DesignationZIIHERAApprovedDesignation
FDA granted Breakthrough Therapy Designation to ZIIHERA in combination with chemotherapy, with and without TEVIMBRA
first-line treatment of unresectable locally advanced/metastatic HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinomasource ↗
▲Topline ReadoutTEVIMBRAApprovedClinical Data
First interim analysis (IA1) results of HERIZON-GEA-01 reported
advanced/metastatic HER2+ GEAsource ↗
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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 %
2026-08-25Tevimbra (tislelizumab-jsgr) PDUFA Date ApprovedPDUFA
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

Pipeline Score
Pipeline Value
Commercial Value
Valuation Signal
35
Drugs Scored
rNPV / MCap
Top Drug
Top 4%
Mid Cap
(rank 27 of 656)
Percentile Rank
Commercial products (revenue basis: trailing 4 quarters of total revenue (10-K and 10-Q), to Jun 2026; product lines from the latest annual filing)
ProductRevenuePrior periodChange
BRUKINSA
TEVIMBRA
XGEVA
BLINCYTO
KYPROLIS
POBEVCY
Showing 94 of 130 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
BGB-43395 Small moleculeNCT07492641HR+/HER2- Breast CancerPhase 3 RECRUITING 1,056Aug 7, 2037
BGB-A445 Small moleculeNCT05661955Urothelial CarcinomaPhase 1 ACTIVE NOT_RECRUITING 113Oct 1, 2026
Tislelizumab Monoclonal antibodyMarketedNCT06091943Non Small Cell Lung CancerPhase 3 ACTIVE NOT_RECRUITING 2,575Jul 31, 2026
Tislelizumab Monoclonal antibodyMarketedNCT07715396Non-small Cell Lung Cancer MetastaticPhase 3 NOT YET_RECRUITING 230Oct 30, 2031
Tislelizumab Monoclonal antibodyNCT03967977Urothelial CarcinomaPhase 3 ACTIVE NOT_RECRUITING 420Oct 21, 2027
Tislelizumab Monoclonal antibodyMarketedNCT07043400Metastatic Gastric AdenocarcinomaPhase 3 RECRUITING 351Apr 22, 2028
Tislelizumab Monoclonal antibodyNCT05909904Head and Neck Squamous Cell CarcinomaPhase 2 ACTIVE NOT_RECRUITING 160May 28, 2026
Tislelizumab Monoclonal antibodyNCT03736889MSI-H/dMMR Solid TumorsPhase 2 RECRUITING 200Sep 1, 2027
Tislelizumab Monoclonal antibodyMarketedNCT07290985Gastroesophageal AdenocarcinomaPhase 2 RECRUITING 242Dec 1, 2028
Tislelizumab Monoclonal antibodyMarketedNCT07733180Advanced Esophageal Squamous Cell CarcinomaPhase 2 RECRUITING 30Feb 28, 2028
Tislelizumab Monoclonal antibodyMarketedNCT07554521Advanced Unresectable Gastric AdenocarcinomaPhase 2 RECRUITING 30Dec 31, 2031
Sonrotoclax Small moleculeNCT06073821CLLPhase 3 ACTIVE NOT_RECRUITING 652Dec 1, 2032
Tacabrutideg Small moleculeNCT06846671CLLPhase 3 RECRUITING 250Feb 14, 2030
Tacabrutideg Small moleculeNCT06970743Chronic Lymphocytic LeukemiaPhase 3 ACTIVE NOT_RECRUITING 653Nov 30, 2029
Sonrotoclax Small moleculeNCT06637501Chronic Lymphocytic LeukemiaPhase 3 ACTIVE NOT_RECRUITING 1,482Sep 1, 2029
Sonrotoclax Small moleculeMarketedNCT05471843Mantle Cell LymphomaPhase 3 ACTIVE NOT_RECRUITING 425Jan 31, 2027
Sonrotoclax Small moleculeNCT05479994LeukemiaPhase 2 ACTIVE NOT_RECRUITING 100Aug 25, 2027
Sonrotoclax Small moleculeNCT05952037Waldenstrom MacroglobulinemiaPhase 2 ACTIVE NOT_RECRUITING 114Aug 1, 2028
Tacabrutideg Small moleculeNCT07005713Chronic Spontaneous UrticariaPhase 1 RECRUITING 58Nov 30, 2026
Sonrotoclax Small moleculeMarketedNCT04883957Mature B-cell MalignanciesPhase 1 ACTIVE NOT_RECRUITING 501Jun 1, 2026
Sonrotoclax Small moleculeNCT06497062Acute Myeloid LeukemiaPhase 1 ACTIVE NOT_RECRUITING 307Jun 30, 2028
Sonrotoclax Small moleculeNCT07770698Relapsed Acute Myeloid LeukemiaPhase 1 NOT YET_RECRUITING 30Sep 1, 2031
Sonrotoclax Small moleculeNCT04973605Relapsed/Refractory Multiple MyelomaPhase 1 RECRUITING 246Nov 1, 2026
Tacabrutideg Small moleculeNCT06634589B-cell MalignancyPhase 1 RECRUITING 915Dec 2, 2029
BG-C9074 Small moleculeNCT07811271Epithelial Ovarian CancerPhase 3 NOT YET_RECRUITING 600Mar 31, 2033
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Clinical Trial Results

Readouts, endpoints and source filings for every ONC program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
ZIIHERA HER2+ gastroesophageal adenocarcinomaPhase 32026-08-31statistically significant overall survival benefitRead MoreBeOne Medicines Announces New Phase 3 Survival Data Reinforcing Benefit of ZIIHERA-Containing Regimens in First-Line HER2+ Gastroesophageal CancerRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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InsiderSideSharesPriceValueDate
Lee Chan HenryOfficer (SVP, General Counsel)Sell -1,115 $375.00 09/30/2026
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Hedge Fund 13F Activity

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)
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Options Data

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Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-10-16
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Real-Time Option Chain

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Competitive positioning

How ONC ranks across every disease it competes in

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See how ONC ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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ONC News

ONC
Sep 1, 2026
ONCGeneral

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 →
ONC
Sep 1, 2026
ONCGeneral

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.

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ONC
Sep 1, 2026
ONCGeneral

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.

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ONC
Sep 1, 2026
ONCGeneral

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 →
ONC
Sep 1, 2026
ONCGeneral

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 →
ONC
Sep 1, 2026
ONCConferences/Events

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.

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ONC
Aug 31, 2026
ONCGeneral

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 →
ONC
Aug 31, 2026
ONCPhases

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 →
ONC
Aug 31, 2026
ONCPhases

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 →
ONC
Aug 31, 2026
ONCPhases

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 →
ONC
Aug 31, 2026
ONCPhases

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 →
ONC
Aug 26, 2026
ONCFDA Updates

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 →
ONC
Aug 26, 2026
ONCFDA Updates

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 →
ONC
Aug 26, 2026
ONCFDA Updates

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 →
ONC
Aug 25, 2026
ONCFDA Updates

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 →
ONC
Aug 18, 2026
ONCGeneral

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.

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ONC
Aug 18, 2026
ONCGeneral

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 →
ONC
Aug 18, 2026
ONCGeneral

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.

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ONC
Aug 10, 2026
ONCGeneral

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.

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ONC
Aug 10, 2026
ONCGeneral

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 →

About BeOne Medicines Ltd.

C/O Beone Medicines I Gmbh, BASEL 12,000 employees beonemedicines.com
HeadquartersC/O BEONE MEDICINES I GMBH, BASEL, 4051
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