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Bristol Myers (BMY) Thrombosis Drug Gets Fast Track Designation
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Bristol Myers (BMY - Free Report) announced that pipeline candidate milvexian has been 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) .
The Fast Track 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. The Librexia program will provide extensive data from nearly 50,000 patients.
Librexia STROKE is a phase III, randomized, double-blind, parallel-group, placebo-controlled study to demonstrate the efficacy and safety of milvexian in addition to single or dual antiplatelet therapy for stroke prevention after an acute ischemic stroke or high-risk transient ischemic attack (TIA). Librexia ACS is a randomized, double-blind, placebo-controlled, event-driven study to demonstrate the efficacy and safety of milvexian after a recent acute coronary syndrome. Librexia AF is a randomized, double-blind, double-dummy, parallel-group, active-controlled study to evaluate the efficacy and safety of milvexian versus apixaban in participants with atrial fibrillation.
The designation is intended to fasten the development and review timelines of drugs when preliminary nonclinical and clinical evidence indicates the drug may demonstrate substantial improvement over available therapies to address unmet medical needs for serious or life-threatening conditions. The benefits of this designation include close communication between the FDA and the sponsor to improve the efficiency of product development to get new therapeutics to patients faster.
Bristol Myers and Johnson and Johnson’s Janssen collaborated in 2018 for the development and commercialization of milvexian. Per the deal, Janssen will pay BMY potential development and regulatory milestone payments.
Bristol Myers shares have lost 10.6% in the year so far compared with the industry's decline of 9.3%.
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.
The company also announced results from the primary analysis of the pivotal TRANSCEND CLL 004 study, a phase I/II, open-label, single-arm multicenter study evaluating Breyanzi (lisocabtagene maraleucel, liso-cel) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Results from the primary analysis showed 18.4% of patients treated with Breyanzi achieved a complete response (CR) and the median duration of CR was not reached at a median follow-up of 21.1 months.
Bristol Myers beat first-quarter 2023 earnings estimates but missed on sales, which declined year over year due to continued generic competition for Revlimid. Generic competition for Eliquis is another headwind.
Bristol Myers currently carries a Zacks Rank #3 (Hold).
Over the past 30 days, earnings estimates for LGND have increased by 63 cents to $4.79. 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 $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.
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Bristol Myers (BMY) Thrombosis Drug Gets Fast Track Designation
Bristol Myers (BMY - Free Report) announced that pipeline candidate milvexian has been 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) .
The Fast Track 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. The Librexia program will provide extensive data from nearly 50,000 patients.
Librexia STROKE is a phase III, randomized, double-blind, parallel-group, placebo-controlled study to demonstrate the efficacy and safety of milvexian in addition to single or dual antiplatelet therapy for stroke prevention after an acute ischemic stroke or high-risk transient ischemic attack (TIA). Librexia ACS is a randomized, double-blind, placebo-controlled, event-driven study to demonstrate the efficacy and safety of milvexian after a recent acute coronary syndrome. Librexia AF is a randomized, double-blind, double-dummy, parallel-group, active-controlled study to evaluate the efficacy and safety of milvexian versus apixaban in participants with atrial fibrillation.
The designation is intended to fasten the development and review timelines of drugs when preliminary nonclinical and clinical evidence indicates the drug may demonstrate substantial improvement over available therapies to address unmet medical needs for serious or life-threatening conditions. The benefits of this designation include close communication between the FDA and the sponsor to improve the efficiency of product development to get new therapeutics to patients faster.
Bristol Myers and Johnson and Johnson’s Janssen collaborated in 2018 for the development and commercialization of milvexian. Per the deal, Janssen will pay BMY potential development and regulatory milestone payments.
Bristol Myers shares have lost 10.6% in the year so far compared with the industry's decline of 9.3%.
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.
The company also announced results from the primary analysis of the pivotal TRANSCEND CLL 004 study, a phase I/II, open-label, single-arm multicenter study evaluating Breyanzi (lisocabtagene maraleucel, liso-cel) in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Results from the primary analysis showed 18.4% of patients treated with Breyanzi achieved a complete response (CR) and the median duration of CR was not reached at a median follow-up of 21.1 months.
Bristol Myers beat first-quarter 2023 earnings estimates but missed on sales, which declined year over year due to continued generic competition for Revlimid. Generic competition for Eliquis is another headwind.
Bristol Myers currently carries a Zacks Rank #3 (Hold).
Some top-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 63 cents to $4.79. 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 $6.57 for 2023. Novartis surpassed estimates in all the trailing four quarters, the average surprise being 5.15%.