Investing.com -- BeOne Medicines AG (NASDAQ:ONC) stock rose around 3% in premarket trading Wednesday, before paring gains, after the FDA accepted and granted Priority Review to its New Drug Application for sonrotoclax, a next-generation BCL2 inhibitor for treating relapsed or refractory mantle cell lymphoma in adults.
The treatment is designed for patients who have previously undergone therapy with a Bruton’s tyrosine kinase inhibitor. The FDA’s Priority Review designation follows an earlier Breakthrough Therapy Designation for the drug, highlighting the regulatory momentum behind the company’s oncology pipeline.
"Sonrotoclax is advancing with remarkable speed, from Breakthrough Therapy Designation to Priority Review, all within a short window," said Lai Wang, Ph.D., Global Head of R&D at BeOne. "That pace reflects both the strength of the data and the urgency of the need for patients with R/R MCL."
The application is supported by data from a global Phase 1/2 study involving 125 patients with relapsed or refractory mantle cell lymphoma. The drug met its primary endpoint of overall response rate as assessed by an independent review committee, while also showing promising results across secondary efficacy measures including complete response rate, duration of response, and progression-free survival.
BeOne plans to present full results from the study at the American Society of Hematology Annual Meeting in December. The company is also participating in the FDA’s Project Orbis initiative, which enables concurrent regulatory submissions across multiple countries, and has applications under review by China’s National Medical Products Administration for both mantle cell lymphoma and chronic lymphocytic leukemia indications.
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