BeOne Medicines Receives FDA Accelerated Approval for Beqalzi
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 13 2026
0mins
Source: seekingalpha
- FDA Accelerated Approval: BeOne Medicines' lymphoma therapy Beqalzi has received accelerated approval from the FDA, marking the first BCL2 inhibitor approved in the U.S. in a decade, representing a significant breakthrough for the company in cancer treatment.
- Significant Market Potential: As a late-line treatment option, the drug targets approximately 3,300 newly diagnosed adults with relapsed or refractory mantle cell lymphoma each year, expected to significantly enhance treatment options and quality of life for patients.
- Ongoing Research Requirement: The continued approval of Beqalzi is contingent upon positive data from the ongoing CELESTIAL-RRMCL confirmatory trial, which is being conducted internationally to ensure the drug's long-term efficacy and safety.
- Revenue Guidance Increase: BeOne projects 2026 revenue between $6.3 billion and $6.5 billion, raising guidance by $100 million, reflecting strong market demand for the new therapy and the company's confidence in future growth.
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Analyst Views on ONC
Wall Street analysts forecast ONC stock price to rise
11 Analyst Rating
11 Buy
0 Hold
0 Sell
Strong Buy
Current: 290.580
Low
385.00
Averages
403.76
High
424.00
Current: 290.580
Low
385.00
Averages
403.76
High
424.00
About ONC
BeOne Medicines AG, formerly BeiGene, Ltd., is a global oncology company engaged in discovering and developing treatments for cancer patients worldwide. With a portfolio spanning hematology and solid tumors, the Company is engaged in the development of its diverse pipeline of novel therapeutics. Its products include Brukinsa, Tevimbra and Pamiparib. Brukinsa is an orally available, small-molecule inhibitor of Bruton’s tyrosine kinase (BTK). Tevimbra is a humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcy) receptors on macrophages, helping the body’s immune cells detect and fight tumors. The Company’s product pipeline in development includes Sonrotoclax, Tarlatamab, Zanidatamab, Blinatumomab, BGB-26808, BGB-R046, BG-68501, BG-C9074, BGB-43395, Xaluritamig, and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
TEVIMBRA and ZIIHERA Combination Therapy Significantly Improves Survival Rates
- Significant Survival Improvement: The HERIZON-GEA-01 trial demonstrated that the combination of TEVIMBRA and ZIIHERA with chemotherapy achieved a median overall survival of 26.4 months, compared to 19.2 months in the control group, indicating the potential importance of this combination in treating HER2+ gastroesophageal adenocarcinoma.
- Effective Regardless of PD-L1 Status: Results showed that this combination therapy provided significant survival benefits in both PD-L1 positive and negative patients, particularly in those with PD-L1 <1%, where the median survival was 29.7 months, far exceeding the control group's 15.8 months, highlighting its broad applicability.
- Strong Durability of Response: The median duration of response for the ZIIHERA and TEVIMBRA combination was 20.7 months, significantly longer than the 14.3 months for ZIIHERA alone and 8.3 months for the control group, underscoring the clinical significance of this combination in prolonging patient survival.
- Regulatory Progress: The U.S. FDA has accepted a supplemental Biologics License Application for TEVIMBRA with priority review, and the Chinese NMPA has also accepted applications for ZIIHERA and TEVIMBRA, indicating that this combination therapy is poised for rapid approval in multiple markets.
See More
BeOne's Drug Shows New Breakthroughs in CLL Treatment
- Long-Term Efficacy Data: The SEQUOIA study indicates that BRUKINSA shows a progression-free survival (PFS) of 71.8% after a median follow-up of 84.01 months, significantly outperforming the 31.0% PFS of the BR group, highlighting its long-term efficacy in first-line treatment for chronic lymphocytic leukemia (CLL).
- Real-World Evidence: An analysis of 10,523 CLL/SLL patients treated with BTK inhibitors revealed that BRUKINSA significantly reduced the risk of death and treatment discontinuation, further solidifying its position as the best-in-class BTK inhibitor.
- Combination Therapy Potential: The combination of BRUKINSA with the next-generation BCL2 inhibitor sonrotoclax demonstrated an unprecedented overall response rate of 100% and a complete response rate of 59.5% in high-risk CLL patients, indicating a promising direction for time-limited treatments.
- Safety Consistency: The safety profile of BRUKINSA remains consistent with previous studies, with no new safety signals identified, ensuring its sustainability and patient confidence in clinical applications.
See More
BeOne Medicines to Participate in Goldman Sachs Healthcare Conference
- Conference Participation: BeOne Medicines will participate in the Goldman Sachs 47th Annual Global Healthcare Conference on June 8, 2026, featuring a fireside chat at 10:00 a.m. EDT, showcasing its latest advancements in oncology treatments.
- Live Webcast Details: The event will be accessible via a live webcast from the investor section of the company's website, ensuring global investors can stay updated in real-time, with an archived version available post-event to enhance information transparency.
- Company Overview: BeOne Medicines is a global oncology company focused on developing innovative treatments for cancer patients, with a portfolio that spans hematology and solid tumors, indicating a broad strategic focus in the oncology sector.
- Global Team Expansion: The company boasts a growing global team across six continents, dedicated to scientific excellence and rapid response, reflecting its strategic importance in delivering treatments to patients more efficiently worldwide.
See More
BeOne Medicines Showcases New Advances at ASCO
- Foundation in CLL: At ASCO and EHA 2026, BeOne showcased 78-month follow-up data from the SEQUOIA trial, reinforcing BRUKINSA® as the foundational BTK inhibitor in chronic lymphocytic leukemia (CLL), demonstrating durable disease control that raises expectations for first-line therapy among patients and physicians.
- Elderly Patient Analysis: A subgroup analysis from the SEQUOIA trial revealed that patients aged ≥80 years also benefited from treatment, indicating that age does not limit therapeutic efficacy, thereby solidifying BeOne's position in treating older patient populations.
- New Drug Presentation: The oral presentation of BeOne's BTK degrader BGB-16673 at EHA 2026 highlighted promising durability and manageable safety in relapsed/refractory CLL patients, with previously unreported data in BTK-naïve patients generating significant interest.
- Solid Tumor Pipeline Acceleration: BeOne demonstrated strong momentum in its solid tumor pipeline at ASCO, featuring seven unique assets, emphasizing the differentiated profile of PD-1 inhibitor TEVIMBRA® across lung and gastrointestinal cancers, showcasing its potential in areas of high unmet medical need.
See More
BeOne Launches Soccer Campaign to Enhance Cancer Care
- Campaign Launch: BeOne Medicines has initiated the 'One Save Changes Everything' campaign, leveraging soccer to enhance the scientific, clinical, and human aspects of cancer care, supported by former U.S. National Team goalkeeper Tim Howard, highlighting the company's commitment to patients.
- Community Commitment: BeOne is investing $300,000 in partnership with the U.S. Soccer Foundation to install soccer mini-pitches near cancer treatment centers, aiming to create spaces for movement and connection for families affected by cancer, thereby improving patients' quality of life.
- Employee Engagement: With over 12,000 employees, BeOne will convert volunteer hours into charitable donations during the campaign, further supporting the U.S. Soccer Foundation and other nonprofits, reflecting the company's dedication to social responsibility.
- Global Reach: The campaign will not only focus on the U.S. but also attract more international goalkeepers and voices from the cancer community, showcasing BeOne's global influence and ongoing commitment to advancing cancer care worldwide.
See More
BeOne's Drug Receives FDA Accelerated Approval
- FDA Accelerated Approval: BeOne's BEQALZI receives FDA accelerated approval, marking the first new B-cell lymphoma 2 inhibitor approved in nearly a decade, which signifies a major advancement in treating relapsed or refractory mantle cell lymphoma and is expected to enhance the company's market competitiveness.
- Clinical Data Support: The drug demonstrated a 52% overall response rate and a 16% complete response rate in clinical trials, with a median duration of response of 15.8 months, indicating strong performance in terms of efficacy and tolerability, potentially attracting more patients to its use.
- Market Potential: With approximately 3,300 new mantle cell lymphoma patients diagnosed annually in the U.S., the approval of BEQALZI provides a new treatment option for these patients, likely driving BeOne's market share growth in the oncology sector.
- Regulatory Follow-Up: Despite the accelerated approval, BeOne stated that continued approval will depend on the results of confirmatory trials, indicating that the company must continue to invest resources to ensure long-term market compliance for the drug.
See More
TEVIMBRA and ZIIHERA Combination Therapy Significantly Improves Survival Rates
- Significant Survival Improvement: The HERIZON-GEA-01 trial demonstrated that the combination of TEVIMBRA and ZIIHERA with chemotherapy achieved a median overall survival of 26.4 months, compared to 19.2 months in the control group, indicating the potential importance of this combination in treating HER2+ gastroesophageal adenocarcinoma.
- Effective Regardless of PD-L1 Status: Results showed that this combination therapy provided significant survival benefits in both PD-L1 positive and negative patients, particularly in those with PD-L1 <1%, where the median survival was 29.7 months, far exceeding the control group's 15.8 months, highlighting its broad applicability.
- Strong Durability of Response: The median duration of response for the ZIIHERA and TEVIMBRA combination was 20.7 months, significantly longer than the 14.3 months for ZIIHERA alone and 8.3 months for the control group, underscoring the clinical significance of this combination in prolonging patient survival.
- Regulatory Progress: The U.S. FDA has accepted a supplemental Biologics License Application for TEVIMBRA with priority review, and the Chinese NMPA has also accepted applications for ZIIHERA and TEVIMBRA, indicating that this combination therapy is poised for rapid approval in multiple markets.
See More
BeOne's Drug Shows New Breakthroughs in CLL Treatment
- Long-Term Efficacy Data: The SEQUOIA study indicates that BRUKINSA shows a progression-free survival (PFS) of 71.8% after a median follow-up of 84.01 months, significantly outperforming the 31.0% PFS of the BR group, highlighting its long-term efficacy in first-line treatment for chronic lymphocytic leukemia (CLL).
- Real-World Evidence: An analysis of 10,523 CLL/SLL patients treated with BTK inhibitors revealed that BRUKINSA significantly reduced the risk of death and treatment discontinuation, further solidifying its position as the best-in-class BTK inhibitor.
- Combination Therapy Potential: The combination of BRUKINSA with the next-generation BCL2 inhibitor sonrotoclax demonstrated an unprecedented overall response rate of 100% and a complete response rate of 59.5% in high-risk CLL patients, indicating a promising direction for time-limited treatments.
- Safety Consistency: The safety profile of BRUKINSA remains consistent with previous studies, with no new safety signals identified, ensuring its sustainability and patient confidence in clinical applications.
See More
BeOne Medicines to Participate in Goldman Sachs Healthcare Conference
- Conference Participation: BeOne Medicines will participate in the Goldman Sachs 47th Annual Global Healthcare Conference on June 8, 2026, featuring a fireside chat at 10:00 a.m. EDT, showcasing its latest advancements in oncology treatments.
- Live Webcast Details: The event will be accessible via a live webcast from the investor section of the company's website, ensuring global investors can stay updated in real-time, with an archived version available post-event to enhance information transparency.
- Company Overview: BeOne Medicines is a global oncology company focused on developing innovative treatments for cancer patients, with a portfolio that spans hematology and solid tumors, indicating a broad strategic focus in the oncology sector.
- Global Team Expansion: The company boasts a growing global team across six continents, dedicated to scientific excellence and rapid response, reflecting its strategic importance in delivering treatments to patients more efficiently worldwide.
See More
BeOne Medicines Showcases New Advances at ASCO
- Foundation in CLL: At ASCO and EHA 2026, BeOne showcased 78-month follow-up data from the SEQUOIA trial, reinforcing BRUKINSA® as the foundational BTK inhibitor in chronic lymphocytic leukemia (CLL), demonstrating durable disease control that raises expectations for first-line therapy among patients and physicians.
- Elderly Patient Analysis: A subgroup analysis from the SEQUOIA trial revealed that patients aged ≥80 years also benefited from treatment, indicating that age does not limit therapeutic efficacy, thereby solidifying BeOne's position in treating older patient populations.
- New Drug Presentation: The oral presentation of BeOne's BTK degrader BGB-16673 at EHA 2026 highlighted promising durability and manageable safety in relapsed/refractory CLL patients, with previously unreported data in BTK-naïve patients generating significant interest.
- Solid Tumor Pipeline Acceleration: BeOne demonstrated strong momentum in its solid tumor pipeline at ASCO, featuring seven unique assets, emphasizing the differentiated profile of PD-1 inhibitor TEVIMBRA® across lung and gastrointestinal cancers, showcasing its potential in areas of high unmet medical need.
See More
BeOne Launches Soccer Campaign to Enhance Cancer Care
- Campaign Launch: BeOne Medicines has initiated the 'One Save Changes Everything' campaign, leveraging soccer to enhance the scientific, clinical, and human aspects of cancer care, supported by former U.S. National Team goalkeeper Tim Howard, highlighting the company's commitment to patients.
- Community Commitment: BeOne is investing $300,000 in partnership with the U.S. Soccer Foundation to install soccer mini-pitches near cancer treatment centers, aiming to create spaces for movement and connection for families affected by cancer, thereby improving patients' quality of life.
- Employee Engagement: With over 12,000 employees, BeOne will convert volunteer hours into charitable donations during the campaign, further supporting the U.S. Soccer Foundation and other nonprofits, reflecting the company's dedication to social responsibility.
- Global Reach: The campaign will not only focus on the U.S. but also attract more international goalkeepers and voices from the cancer community, showcasing BeOne's global influence and ongoing commitment to advancing cancer care worldwide.
See More
BeOne's Drug Receives FDA Accelerated Approval
- FDA Accelerated Approval: BeOne's BEQALZI receives FDA accelerated approval, marking the first new B-cell lymphoma 2 inhibitor approved in nearly a decade, which signifies a major advancement in treating relapsed or refractory mantle cell lymphoma and is expected to enhance the company's market competitiveness.
- Clinical Data Support: The drug demonstrated a 52% overall response rate and a 16% complete response rate in clinical trials, with a median duration of response of 15.8 months, indicating strong performance in terms of efficacy and tolerability, potentially attracting more patients to its use.
- Market Potential: With approximately 3,300 new mantle cell lymphoma patients diagnosed annually in the U.S., the approval of BEQALZI provides a new treatment option for these patients, likely driving BeOne's market share growth in the oncology sector.
- Regulatory Follow-Up: Despite the accelerated approval, BeOne stated that continued approval will depend on the results of confirmatory trials, indicating that the company must continue to invest resources to ensure long-term market compliance for the drug.
See More
