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Bristol Myers' (BMY) CAR T-Cell Therapy BLA Review Delayed
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Bristol Myers Squibb (BMY - Free Report) announced that the FDA has informed of a delay in its review of the Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel).
Liso-cel is an investigational chimeric antigen receptor (CAR) T-cell therapy. The candidate was added to the company’s portfolio with the acquisition of Celgene Corporation.
The BLA is seeking approval of the therapy for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies. The FDA notified the company that the review will not be completed by the Prescription Drug User Fee Act (PDUFA) action date of Nov 16, 2020.
The agency was unable to conduct an inspection of a third-party manufacturing facility in Texas during the current review cycle due to travel restrictions related to the COVID-19 pandemic. Hence, the FDA is deferring action on the application until the inspection is done. The application remains under review and the agency did not provide a new anticipated action date.
The BLA is based on the safety and efficacy results from the TRANSCEND NHL 001 study, evaluating liso-cel in 268 patients with R/R large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma, primary mediastinal B-cell lymphoma and Grade 3B follicular lymphoma.
Meanwhile, the FDA approval of liso-cel by Dec 31 is one of the required remaining milestones for the Contingent Value Rights issued upon the close of the Celgene acquisition in the fourth quarter of 2019. The other one remaining is the FDA approval of Idecabtagene Vicleucel (ide-cel) by Mar 31, 2021.
Per the terms of the acquisition, upon closure, Celgene shareholders received for each share, 1.00 share of Bristol Myers common stock, $50.00 in cash without interest and one tradeable Contingent Value Right (CVR), which will entitle the holder to receive a payment of $9.00 in cash if certain future regulatory milestones are achieved.
Bristol-Myers’ shares have gained 0.5% in the year so far, in line with the industry's performance.
The company’s performance in the third quarter was encouraging as Revlimid and Eliquis drove growth. Earnings and sales beat estimates primarily on the addition of Celgene’s drugs to its portfolio. However, the decline in Opdivo sales is concerning. The drug faces stiff competition from Merck’s (MRK - Free Report) Keytruda.
Halozyme’s earnings estimates are up 14 cents in the past 30 days.
Vanda’s earnings estimates have been raised 12 cents for 2020 in the past 30 days.
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Bristol Myers' (BMY) CAR T-Cell Therapy BLA Review Delayed
Bristol Myers Squibb (BMY - Free Report) announced that the FDA has informed of a delay in its review of the Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel).
Liso-cel is an investigational chimeric antigen receptor (CAR) T-cell therapy. The candidate was added to the company’s portfolio with the acquisition of Celgene Corporation.
The BLA is seeking approval of the therapy for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies. The FDA notified the company that the review will not be completed by the Prescription Drug User Fee Act (PDUFA) action date of Nov 16, 2020.
The agency was unable to conduct an inspection of a third-party manufacturing facility in Texas during the current review cycle due to travel restrictions related to the COVID-19 pandemic. Hence, the FDA is deferring action on the application until the inspection is done. The application remains under review and the agency did not provide a new anticipated action date.
The BLA is based on the safety and efficacy results from the TRANSCEND NHL 001 study, evaluating liso-cel in 268 patients with R/R large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma, primary mediastinal B-cell lymphoma and Grade 3B follicular lymphoma.
Meanwhile, the FDA approval of liso-cel by Dec 31 is one of the required remaining milestones for the Contingent Value Rights issued upon the close of the Celgene acquisition in the fourth quarter of 2019. The other one remaining is the FDA approval of Idecabtagene Vicleucel (ide-cel) by Mar 31, 2021.
Per the terms of the acquisition, upon closure, Celgene shareholders received for each share, 1.00 share of Bristol Myers common stock, $50.00 in cash without interest and one tradeable Contingent Value Right (CVR), which will entitle the holder to receive a payment of $9.00 in cash if certain future regulatory milestones are achieved.
Bristol-Myers’ shares have gained 0.5% in the year so far, in line with the industry's performance.
The company’s performance in the third quarter was encouraging as Revlimid and Eliquis drove growth. Earnings and sales beat estimates primarily on the addition of Celgene’s drugs to its portfolio. However, the decline in Opdivo sales is concerning. The drug faces stiff competition from Merck’s (MRK - Free Report) Keytruda.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the biotech space are Vanda Pharmaceuticals (VNDA - Free Report) and Halozyme Therapeutics, Inc. (HALO - Free Report) . Both carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Halozyme’s earnings estimates are up 14 cents in the past 30 days.
Vanda’s earnings estimates have been raised 12 cents for 2020 in the past 30 days.
Legal Marijuana: An Investor’s Dream
Imagine getting in early on a young industry primed to skyrocket from $17.7 billion in 2019 to an expected $73.6 billion by 2027.
Although marijuana stocks did better as the pandemic took hold than the mZRSarket as a whole, they’ve been pushed down. This is exactly the right time to get in on selected strong companies at a fraction of their value before COVID struck. Zacks’ Special Report, Marijuana Moneymakers, reveals 10 exciting tickers for urgent consideration.
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