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Bristol Myers' (BMY) Lung Cancer Drug NDA Gets Priority Review
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Bristol Myers Squibb (BMY - Free Report) announced that the FDA accepted the new drug application (NDA) for repotrectinib. The NDA is seeking approval for this next-generation tyrosine kinase inhibitor (TKI) for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
The regulatory body has granted Priority Review to the application and assigned a target action date of Nov 27, 2023.
The NDA was based on positive results from the registrational TRIDENT-1 study, where repotrectinib demonstrated high response rates and clinically meaningful durability of benefit in both TKI-naïve and TKI-pretreated patients, including those with ROS1 resistance mutations. The safety profile of repotrectinib was well-characterized and manageable. The ongoing study is assessing long-term outcomes and additional endpoints across patient populations with ROS1-positive locally advanced or metastatic NSCLC and NTRK-positive advanced solid tumors.
The candidate was added to BMY’s pipeline with the acquisition of clinical-stage precision oncology company Turning Point Therapeutics in August 2022.
Bristol Myers shares have lost 11.5% in the year so far compared with the industry's decline of 9.7%.
Image Source: Zacks Investment Research
The successful development of new drugs will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as one of its prime drugs, Revlimid, is facing generic competition.
Last week, BMY announced that pipeline candidate milvexian was granted Fast Track Designation by the FDA for all three prospective indications.
Milvexian is an investigational oral factor XIa (FXIa) inhibitor (antithrombotic) being studied for the prevention and treatment of major thrombotic conditions as part of the Librexia program in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson (JNJ - Free Report) .
This designation covers all three indication-seeking studies within the phase III Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all currently dosing patients. Bristol Myers and Johnson and Johnson’s Janssen collaborated in 2018 to develop and commercialize milvexian. Per the deal, Janssen pays BMY potential development and regulatory milestone payments.
BMY’s psoriasis drug Sotyktu (deucravacitinib) recently got approved by the European Commission (EC). Sotyktu is a first-in-class, selective tyrosine kinase 2 (TYK2) inhibitor for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, representing a new way of treating this chronic immune-mediated disease. It is already approved in the United States.
Bristol Myers currently carries a Zacks Rank #3 (Hold).
Over the past 30 days, earnings estimates for LGND have increased by $1.09 to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 30 days, NVS’ earnings estimates have increased to $6.67 from $6.56 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
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Bristol Myers' (BMY) Lung Cancer Drug NDA Gets Priority Review
Bristol Myers Squibb (BMY - Free Report) announced that the FDA accepted the new drug application (NDA) for repotrectinib. The NDA is seeking approval for this next-generation tyrosine kinase inhibitor (TKI) for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
The regulatory body has granted Priority Review to the application and assigned a target action date of Nov 27, 2023.
The NDA was based on positive results from the registrational TRIDENT-1 study, where repotrectinib demonstrated high response rates and clinically meaningful durability of benefit in both TKI-naïve and TKI-pretreated patients, including those with ROS1 resistance mutations. The safety profile of repotrectinib was well-characterized and manageable. The ongoing study is assessing long-term outcomes and additional endpoints across patient populations with ROS1-positive locally advanced or metastatic NSCLC and NTRK-positive advanced solid tumors.
The candidate was added to BMY’s pipeline with the acquisition of clinical-stage precision oncology company Turning Point Therapeutics in August 2022.
Bristol Myers shares have lost 11.5% in the year so far compared with the industry's decline of 9.7%.
Image Source: Zacks Investment Research
The successful development of new drugs will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as one of its prime drugs, Revlimid, is facing generic competition.
Last week, BMY announced that pipeline candidate milvexian was granted Fast Track Designation by the FDA for all three prospective indications.
Milvexian is an investigational oral factor XIa (FXIa) inhibitor (antithrombotic) being studied for the prevention and treatment of major thrombotic conditions as part of the Librexia program in collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson and Johnson (JNJ - Free Report) .
This designation covers all three indication-seeking studies within the phase III Librexia development program (Librexia STROKE, Librexia ACS and Librexia AF), which are all currently dosing patients. Bristol Myers and Johnson and Johnson’s Janssen collaborated in 2018 to develop and commercialize milvexian. Per the deal, Janssen pays BMY potential development and regulatory milestone payments.
BMY’s psoriasis drug Sotyktu (deucravacitinib) recently got approved by the European Commission (EC). Sotyktu is a first-in-class, selective tyrosine kinase 2 (TYK2) inhibitor for treating adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy, representing a new way of treating this chronic immune-mediated disease. It is already approved in the United States.
Bristol Myers currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Ligand Pharmaceuticals (LGND - Free Report) and Novartis (NVS - Free Report) . LGND currently sports a Zacks Rank #1 (Strong Buy) and Novartis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 30 days, earnings estimates for LGND have increased by $1.09 to $5.25. LGND topped earnings estimates in two of the last four quarters and missed in the remaining two, the average surprise being 21.50%.
Over the past 30 days, NVS’ earnings estimates have increased to $6.67 from $6.56 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.