BeOne Medicines’ Sonrotoclax Granted Breakthrough Therapy Designation by U.S. FDA
BeOne Medicines Ltd. - American Depositary Shares (ONC)
Company Research
Source: Business Wire
Breakthrough designation based on early, positive results of a Phase 1/2 study of sonrotoclax in patients with relapsed or refractory mantle cell lymphoma (MCL)BeOne to participate in Project Orbis program, supporting efforts to rapidly advance global access SAN CARLOS, Calif.--(BUSINESS WIRE)--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 Breakthrough Therapy Designation (BTD) for sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL). Additionally, the FDA has accepted BeOne’s request for participation in Project Orbis, an initiative that provides a framework for concurrent submission and review of oncology products among participating global health authorities.“Breakthrough Therapy Designation is reserved for medicines with the
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News
- U.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell LymphomaBusiness Wire
- BeOne Medicines (NASDAQ:ONC) was given a new $400.00 price target on by analysts at Truist Financial Corporation.MarketBeat
- BeOne Medicines (NASDAQ:ONC) is now covered by analysts at Truist Financial Corporation. They set a "buy" rating on the stock.MarketBeat
- BeOne Medicines Showcases Leadership in B-cell Malignancies at ASH 2025Business Wire
- BeOne Medicines (NASDAQ:ONC) had its price target raised by analysts at Royal Bank Of Canada from $395.00 to $408.00. They now have an "outperform" rating on the stock.MarketBeat
ONC
Earnings
- 11/6/25 - Beat
ONC
Sec Filings
- 12/1/25 - Form 4
- 11/19/25 - Form 4
- 11/14/25 - Form 4
- ONC's page on the SEC website