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.
Bristol Myers' (BMY) Breyanzi sBLA Receives EMA Validation
Read MoreHide Full Article
Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Medicines Agency ("EMA") has validated the type II variation filing for the label expansion of its CD19-directed CAR-T cell therapy, Breyanzi (lisocabtagenemaraleucel).
The application is seeking approval of Breyanzi for the treatment of diffuse large B-cell lymphoma (“DLBCL”), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma (“PMBCL”) and follicular lymphoma grade 3B (FL3B) in adult patients who are refractory or have relapsed within 12 months of initial therapy and are candidates for haematopoietic stem cell transplant (“HSCT”).
The European Commission approved Breyanzi for treating adult patients with relapsed or refractory DLBCL, PMBCL and FL3B, following two or more lines of systemic therapy in April 2022.
The latest type II variation filing was based on data from the phase III TRANSFORM study, which investigated Breyanzi as a second-line treatment in adults with relapsed or refractory LBCL versus standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus HSCT. Data from the same showed that treatment with Breyanzi significantly improved event-free survival — the study’s primary endpoint — as compared to standard of care.
Treatment with Breyanzi also led to clinically meaningful and statistically significant improvements in complete response rates and progression-free survival versus standard of care. Breyanzi demonstrated a well-established safety profile.
Shares of Bristol Myers have rallied 18.3% so far this year against the industry’s decline of 28%.
Image Source: Zacks Investment Research
Breyanzi is currently approved in the United States for the treatment of adult patients with R/R large B-cell lymphoma or LBCL after two or more lines of systemic therapy, including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, PMBCL, and FL3B.
In the United States, Breyanzi is also under review for the treatment of adult patients with R/R LBCL after the failure of first-line therapy. In February 2022, the FDA granted priority review to the supplemental biologics license application of Breyanzi for this indication. A decision from the regulatory body is expected on Jun 24, 2022.
Breyanzi, one of the newer drugs of Bristol Myers, has been performing steadily since its launch. Breyanzi generated sales worth $44 million in the first quarter of 2022. A potential label expansion of the drug should boost its sales in the future quarters.
The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 in the past 60 days.
Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.
Aeglea BioTherapeutics’ loss per share estimates narrowed 19.4% for 2022 and 37.5% for 2023 in the past 60 days.
Earnings of Aeglea BioTherapeutics have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. AGLE delivered an earnings surprise of 9.47%, on average.
Precision BioSciences’ loss per share estimates narrowed 21.7% for 2022 and 31.4% for 2023 in the past 60 days.
Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Shutterstock
Bristol Myers' (BMY) Breyanzi sBLA Receives EMA Validation
Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Medicines Agency ("EMA") has validated the type II variation filing for the label expansion of its CD19-directed CAR-T cell therapy, Breyanzi (lisocabtagenemaraleucel).
The application is seeking approval of Breyanzi for the treatment of diffuse large B-cell lymphoma (“DLBCL”), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma (“PMBCL”) and follicular lymphoma grade 3B (FL3B) in adult patients who are refractory or have relapsed within 12 months of initial therapy and are candidates for haematopoietic stem cell transplant (“HSCT”).
The European Commission approved Breyanzi for treating adult patients with relapsed or refractory DLBCL, PMBCL and FL3B, following two or more lines of systemic therapy in April 2022.
The latest type II variation filing was based on data from the phase III TRANSFORM study, which investigated Breyanzi as a second-line treatment in adults with relapsed or refractory LBCL versus standard of care consisting of salvage chemotherapy followed by high-dose chemotherapy plus HSCT. Data from the same showed that treatment with Breyanzi significantly improved event-free survival — the study’s primary endpoint — as compared to standard of care.
Treatment with Breyanzi also led to clinically meaningful and statistically significant improvements in complete response rates and progression-free survival versus standard of care. Breyanzi demonstrated a well-established safety profile.
Shares of Bristol Myers have rallied 18.3% so far this year against the industry’s decline of 28%.
Image Source: Zacks Investment Research
Breyanzi is currently approved in the United States for the treatment of adult patients with R/R large B-cell lymphoma or LBCL after two or more lines of systemic therapy, including DLBCL not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, PMBCL, and FL3B.
In the United States, Breyanzi is also under review for the treatment of adult patients with R/R LBCL after the failure of first-line therapy. In February 2022, the FDA granted priority review to the supplemental biologics license application of Breyanzi for this indication. A decision from the regulatory body is expected on Jun 24, 2022.
Breyanzi, one of the newer drugs of Bristol Myers, has been performing steadily since its launch. Breyanzi generated sales worth $44 million in the first quarter of 2022. A potential label expansion of the drug should boost its sales in the future quarters.
Zacks Rank & Stocks to Consider
Bristol Myers currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector are Leap Therapeutics, Inc. (LPTX - Free Report) , Aeglea BioTherapeutics, Inc. and Precision BioSciences, Inc. (DTIL - Free Report) , all carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 in the past 60 days.
Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.
Aeglea BioTherapeutics’ loss per share estimates narrowed 19.4% for 2022 and 37.5% for 2023 in the past 60 days.
Earnings of Aeglea BioTherapeutics have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions. AGLE delivered an earnings surprise of 9.47%, on average.
Precision BioSciences’ loss per share estimates narrowed 21.7% for 2022 and 31.4% for 2023 in the past 60 days.
Earnings of Precision BioSciences have surpassed estimates in each of the trailing four quarters. DTIL delivered an earnings surprise of 76.15%, on average.