We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
BeiGene's (BGNE) BLA for Tislelizumab in ESCC Accepted by FDA
Read MoreHide Full Article
BeiGene, Ltd. (BGNE - Free Report) announced that the FDA has accepted the biologics license application (“BLA”) for its anti-PD-1 antibody, tislelizumab, as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (“ESCC”), following prior systemic therapy. A decision from the regulatory body is expected on Jul 12, 2022.
The BLA was based on data from the open-label, multicenter phase III RATIONALE 302 study, which evaluated the safety and efficacy of tislelizumab as compared to investigator’s choice chemotherapy as a second-line treatment for patients with advanced/metastatic ESCC.
The BLA also included safety data from patients who received tislelizumab as a monotherapy across a broad clinical program. The BLA was filed in collaboration with Novartis (NVS - Free Report) .
Shares of BeiGene were up in pre-market trading on Monday. In fact, the stock has rallied 36.3% so far this year compared with the industry’s rise of 0.8%.
Image Source: Zacks Investment Research
We remind investors that, in January 2021, Novartis entered into a strategic collaboration agreement with BeiGene, following which the former in-licensed tislelizumab in major markets outside of China. The above-mentioned BLA is the first regulatory filing for tislelizumab outside Chinese territory.
Per the company, tislelizumab is an anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It is approved in China for five oncological indications. Tislelizumab is also under review as a treatment for patients with locally advanced or metastatic ESCC who have disease progression following first-line standard chemotherapy, or are intolerant to the same, in China.
BeiGene currently markets three internally discovered oncology products — BTK inhibitor, Brukinsa (zanubrutinib), in the United States, Canada and China; anti-PD-1 antibody, tislelizumab, in China; and PARP inhibitor, pamiparib, also in China.
Image: Bigstock
BeiGene's (BGNE) BLA for Tislelizumab in ESCC Accepted by FDA
BeiGene, Ltd. (BGNE - Free Report) announced that the FDA has accepted the biologics license application (“BLA”) for its anti-PD-1 antibody, tislelizumab, as a treatment for patients with unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma (“ESCC”), following prior systemic therapy. A decision from the regulatory body is expected on Jul 12, 2022.
The BLA was based on data from the open-label, multicenter phase III RATIONALE 302 study, which evaluated the safety and efficacy of tislelizumab as compared to investigator’s choice chemotherapy as a second-line treatment for patients with advanced/metastatic ESCC.
The BLA also included safety data from patients who received tislelizumab as a monotherapy across a broad clinical program. The BLA was filed in collaboration with Novartis (NVS - Free Report) .
Shares of BeiGene were up in pre-market trading on Monday. In fact, the stock has rallied 36.3% so far this year compared with the industry’s rise of 0.8%.
Image Source: Zacks Investment Research
We remind investors that, in January 2021, Novartis entered into a strategic collaboration agreement with BeiGene, following which the former in-licensed tislelizumab in major markets outside of China. The above-mentioned BLA is the first regulatory filing for tislelizumab outside Chinese territory.
Per the company, tislelizumab is an anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It is approved in China for five oncological indications. Tislelizumab is also under review as a treatment for patients with locally advanced or metastatic ESCC who have disease progression following first-line standard chemotherapy, or are intolerant to the same, in China.
BeiGene currently markets three internally discovered oncology products — BTK inhibitor, Brukinsa (zanubrutinib), in the United States, Canada and China; anti-PD-1 antibody, tislelizumab, in China; and PARP inhibitor, pamiparib, also in China.
Zacks Rank & Stocks to Consider
BeiGene currently carries a Zacks Rank #4 (Sell).
Better-ranked stocks in the biotech sector include Spero Therapeutics, Inc. (SPRO - Free Report) and Corvus Pharmaceuticals, Inc. (CRVS - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Spero Therapeutics’ loss per share estimates have narrowed 8.2% for 2021 and 10.6% for 2022, over the past 60 days.
Corvus Pharmaceuticals’ loss per share estimates have narrowed 24.4% for 2021 and 21.4% for 2022, over the past 60 days.