BeOne Wins FDA Nod for BEQALZI Lymphoma Therapy

BeOne Medicines ( (ONC) ) has issued an announcement.

On May 13, 2026, BeOne Medicines announced that the U.S. FDA granted accelerated approval to its BCL2 inhibitor BEQALZI (sonrotoclax) for adults with relapsed or refractory mantle cell lymphoma after at least two prior systemic therapies, including a BTK inhibitor. The drug, the first new BCL2 inhibitor approved in the U.S. in a decade and the only one cleared for mantle cell lymphoma, showed a 52% overall response rate and generally manageable safety in a Phase 1/2 trial, with continued approval dependent on a confirmatory study.

The approval strengthens BeOne’s position in the competitive hematology-oncology market by introducing a new targeted option in a difficult post‑BTK setting, where outcomes are typically poor and treatment choices limited. With BEQALZI already approved in China for mantle cell lymphoma and certain CLL/SLL patients and under review in Europe, the decision broadens the drug’s global footprint and underscores BeOne’s strategy to establish BCL2 inhibition as a foundational backbone therapy in B‑cell malignancies, with implications for patients who have exhausted other therapies.

The most recent analyst rating on (ONC) stock is a Buy with a $400.00 price target. To see the full list of analyst forecasts on BeOne Medicines stock, see the ONC Stock Forecast page.

Spark’s Take on ONC Stock

According to Spark, TipRanks’ AI Analyst, ONC is a Outperform.

The score is driven primarily by improving financial performance (turnaround to profitability and positive free cash flow with very strong gross margins) and a supportive earnings outlook with upbeat guidance and pipeline/commercial momentum. These positives are tempered by a still-maturing profitability profile and higher debt versus 2024, mixed longer-term technical trend signals (below 100/200-day averages), and a relatively high P/E with no dividend yield support.

To see Spark’s full report on ONC stock, click here.

More about BeOne Medicines

BeOne Medicines Ltd., listed on Nasdaq, HKEX and SSE, is a global oncology company focused on developing next-generation targeted therapies for B‑cell malignancies. Its pipeline centers on BCL2 inhibition, notably BEQALZI (sonrotoclax), a potentially best‑in‑class, highly potent and selective BCL2 inhibitor being advanced as both monotherapy and in combination regimens across multiple blood cancers.

Average Trading Volume: 240,879

Technical Sentiment Signal: Buy

Current Market Cap: $35.21B

See more data about ONC stock on TipRanks’ Stock Analysis page.