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By Adriano Marchese
BeOne Medicines said U.S. regulators have agreed to fast-track the review its new drug to treat adults with mantle cell lymphoma, a form of blood cancer.
The cancer treatment company said Wednesday that the Food and Drug Administration has accepted and granted priority review to a new drug application for sonrotoclax, a new BCL2 inhibitor intended to treat adult patients with relapsed or refractory mantle cell lymphoma.
Mantle cell lymphoma is a rare, fast-growing blood cancer that starts in the lymph nodes.
The decision was based on data from a phase 1/2 study which enrolled 125 adult patients with the specific type of blood cancer who had received prior treatment. The trial results found that sonorotoclax achieved its primary endpoints of overall response rate, and also showed promising results across several secondary efficacy endpoints, it said.
"Sonrotoclax is advancing with remarkable speed, from breakthrough therapy designation to priority review, all within a short window," Global Head of Research and Development at BeOne, Lai Wang, said.
Write to Adriano Marchese at adriano.marchese@wsj.com
(18:01 GMT) BeOne Medicines Price Target Announced at $400.00/Share by Truist Securities
(18:01 GMT) BeOne Medicines Price Target Announced at $400.00/Share by Truist Securities
(15:39 GMT) BeOne Medicines Price Target Raised to $408.00/Share From $395.00 by RBC Capital
A unique global infrastructure and rapid R&D have driven strong financial growth and a broad pipeline, with leading CLL therapies and innovative solid tumor programs advancing. Strategic investments and disciplined capital allocation support over 20 phase III trials next year.
A proprietary global infrastructure and robust pipeline drive rapid clinical progress and financial growth, with leading CLL assets and expanding solid tumor programs. Strategic investments and AI integration support innovation, while global revenue diversification accelerates.
BeOne Medicines is poised for strong revenue and earnings growth over the next years, backed by a more diversified revenue mix and improving margins, UOB Kay Hian analysts say. Global sales of the company's flagship drug Brukinsa are expected to rise further given its best-in-class profile and expanding market reach. That will boost earnings and cash flow, Carol Dou and Sunny Chen say in a note. BeOne's R&D efforts will also support long-term growth through new product launches, the analysts add. They raise earnings forecasts to reflect stronger-than-expected 3Q results and improved operating efficiency. UOB maintains a buy rating on the stock and lifts its H-share target price to HK$252.00 from HK$240.00. Shares closed at HK$197.40. (jason.chau@wsj.com)
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