SAN MATEO, Calif. - BeiGene (NASDAQ:BGNE), Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE (LON:SSE): 688235), a prominent biotechnology company with a market capitalization of $19.6 billion, soon to be known as BeOne Medicines Ltd., has announced that the U.S. Food and Drug Administration (FDA) has approved TEVIMBRA® (tislelizumab-jsgr) for use in combination with chemotherapy for the first-line treatment of certain types of advanced gastric cancer. According to InvestingPro analysis, BeiGene shows impressive revenue growth of over 50% in the last twelve months, suggesting strong commercial momentum. The approval, marking the second for TEVIMBRA in 2024, is specifically for patients with unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma with PD-L1 expression (≥1%).
The decision by the FDA was supported by the results of the global Phase 3 RATIONALE-305 trial, which demonstrated a statistically significant improvement in overall survival among patients treated with TEVIMBRA and chemotherapy. BeiGene's strong research capabilities are backed by robust financials, with InvestingPro data showing an exceptional gross profit margin of 83.7%. Subscribers to InvestingPro can access 10+ additional exclusive insights about BeiGene's financial health and growth prospects. Patients in the trial achieved a median overall survival of 15.0 months compared to 12.9 months for those receiving placebo plus chemotherapy, translating to a 20% reduction in the risk of death.
The safety profile of TEVIMBRA was evaluated through pooled data from several studies, with the most common severe adverse reactions including neutropenia, thrombocytopenia, and anemia. TEVIMBRA's approval as a monotherapy for esophageal squamous cell carcinoma after prior systemic chemotherapy not including a PD-(L)1 inhibitor remains in effect.
BeiGene's Chief Medical (TASE:PMCN) Officer, Solid Tumors, Mark Lanasa, M.D., Ph.D., expressed gratitude to the patients, clinicians, and researchers involved in the development of TEVIMBRA and highlighted the company's commitment to building on this progress in the coming year.
Gastric cancer is the fifth most common cancer globally and is associated with a high mortality rate. In the United States, approximately 27,000 cases of gastric cancer were diagnosed in 2024, with an estimated 11,000 deaths.
TEVIMBRA is part of BeiGene's broader effort to develop innovative cancer treatments. The TEVIMBRA clinical program has enrolled nearly 14,000 patients in 66 trials across 34 countries, and the medication is approved in more than 42 countries. With analyst price targets ranging from $207 to $376, and a consensus recommendation trending strongly positive according to InvestingPro, the company's growth trajectory appears promising despite current unprofitability.
The information in this article is based on a press release statement from BeiGene, Ltd.
In other recent news, BeiGene, soon to be known as BeOne Medicines Ltd., has announced significant developments. The pharmaceutical company reported a third-quarter revenue of $1.1 billion, a 28% increase from the same period last year, primarily driven by robust sales of their cancer drug, Brukinsa, in the US and Europe. However, the company reported a narrower loss per share of $0.09, lower than the prior-year quarter's earnings per share of $0.15.
TD Cowen reiterated its Buy rating on BeiGene shares, while Morgan Stanley (NYSE:MS) resumed coverage with an Overweight rating and set a new price target of $300.00. Bernstein also adjusted their projections based on BeiGene's three significant drugs for B-cell malignancies: zanubrutinib, sonrotoclax, and BGB-16673.
In addition to the earnings and revenue results, BeiGene resolved ongoing patent litigation with MSN Pharmaceuticals concerning Brukinsa, ensuring market exclusivity for this key product in its oncology portfolio well into the next decade. The company also announced a proposed name change to BeOne Medicines Ltd., pending shareholder approval, to better align with its corporate identity. This rebranding will involve a new ticker symbol, "ONC", on the NASDAQ Global Select Market. These are the recent developments in BeiGene.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.