BeOne Medicines Wins Conditional FDA Nod For Cancer Drug In Rare Blood Cancer

The U.S. Food and Drug Administration (FDA) on Wednesday granted accelerated approval to BeOne Medicines Ltd.‘s (NASDAQ:ONC) Beqalzi (sonrotoclax) for adults with relapsed or refractory mantle cell lymphoma who previously received at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor.

Benzinga • May 14, 2026

BeOne Medicines' BEQALZI™ (sonrotoclax) Approved by U.S. FDA as First and Only BCL2 Inhibitor for R/R Mantle Cell Lymphoma

SAN CARLOS, Calif.--(BUSINESS WIRE)---- $ONC #BeOne--BeOne Medicines Ltd. (“BeOne”) (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to BEQALZI™ (bee-KAHL-zee; sonrotoclax), a foundational, next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a Bruton's tyrosine ki.

Business Wire • May 13, 2026

US FDA approves BeOne's drug for a type of blood cancer

BeOne Medicines said on Wednesday that ​the U.S. Food and Drug ‌Administration has approved its drug for a type of blood ​cancer.

Reuters • May 13, 2026

BeOne Medicines Announces First Quarter 2026 Financial Results and Business Updates

SAN CARLOS, Calif.--(BUSINESS WIRE)---- $ONC #BeOne--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the first quarter of 2026. John V. Oyler, Co-Founder, Chairman, and CEO, BeOne, said: “These strong first-quarter results reinforce BeOne's continued growth as a global oncology leader, driven by disciplined commercial execution, and underpinned by our established hematology leadership, and an impressive, rapid.

Business Wire • May 6, 2026

BeOne Medicines AG (ONC) Q1 2026 Earnings Call Transcript

BeOne Medicines AG (ONC) Q1 2026 Earnings Call Transcript

Seeking Alpha • May 6, 2026

U.S. FDA Grants Priority Review to BeOne Medicines' TEVIMBRA in First-Line HER2+ GEA

SAN CARLOS, Calif.--(BUSINESS WIRE)---- $ONC #BeOne--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for TEVIMBRA® (tislelizumab) in combination with ZIIHERA® (zanidatamab) and chemotherapy for the first-line treatment of unresectable locally advanced/metastatic HER2-positive (HER2) gastric, gastroesophageal junction, or eso.

Business Wire • Apr 29, 2026

BeOne Medicines to Announce First Quarter 2026 Financial Results on May 6

SAN CARLOS, Calif.--(BUSINESS WIRE)---- $ONC #BeOne--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, will report its first quarter 2026 financial results on Wednesday, May 6, 2026 before the financial markets open. Following the release of the financials, the Company will host a live webcast with management at 8:00 a.m. ET. The live webcast of this event can be accessed from the investors section of the Company's website at https://ir.beonemedicines.com.To ensure a time.

Business Wire • Apr 22, 2026

BeOne Medicines: Guidance Weighs But Multiple Catalysts In 2026

BeOne Medicines remains a strong buy despite a modest 2026 guidance miss, with a $410/share 12-month price target. Brukinsa's 49% YoY growth to $3.93B in 2025 and best-in-class CLL data underpin ONC's market leadership and profitability inflection. Imminent catalysts include potential FDA approvals for Sonrotoclax (BCL2 inhibitor) and BTK-CDAC (BTK degrader), both poised to drive substantial upside in 2026.

Seeking Alpha • Feb 28, 2026

BeOne Medicines AG (ONC) Q4 2025 Earnings Call Transcript

BeOne Medicines AG (ONC) Q4 2025 Earnings Call Transcript

Seeking Alpha • Feb 26, 2026

BeOne Medicines Announces Fourth Quarter and Full Year 2025 Financial Results, Highlighting Global Success of BRUKINSA and Foundational Oncology Leadership

SAN CARLOS, Calif.--(BUSINESS WIRE)---- $ONC #BeOne--BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the fourth quarter and full year 2025. “These strong financial results for the fourth quarter and full year 2025 underscore our continued evolution as a global oncology leader with durable competitive advantages in clinical development and manufacturing and one of the industry's deepest and most differentiated.

Business Wire • Feb 26, 2026