Bristol-Myers initiated with an Equal Weight at Wells Fargo » 16:2912/0812/08/21
Wells Fargo analyst Mohit…
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Bristol stock too cheap, could be ready to rally, Barron's says » 09:3512/0412/04/21
A healthcare crisis…
A healthcare crisis should have been good for biopharma stocks. Instead, it's been anything but. That may be about to change, Ben Levisohn writes in this week's edition of Barron's. Few pharma companies have been hit as hard as Bristol-Myers, with the stock dropping 11% so far this year amid concerns that it will lose exclusivity on drugs like multiple-myeloma treatment Revlimid in 2022, and cancer treatment Opdivo and blood-clot preventer Eliquis later this decade, the authors notes. But if pharma is cheap, then Bristol, at just seven times 2022 earnings, looks like a bargain-especially if those concerns are overblown, he contends. Reference Link
Bristol-Myers: FDA accepts for priority review sBLA for Reblozyl » 07:0012/0312/03/21
Bristol Myers Squibb…
Bristol Myers Squibb (BMY) announced that the U.S. FDA has accepted for priority review the supplemental Biologics License Application for Reblozyl, a first-in-class erythroid maturation agent, for the treatment of anemia in adults with non-transfusion dependent beta thalassemia. The FDA has set a Prescription Drug User Fee Act goal date of March 27, 2022. In addition, the European Medicines Agency has validated the Type II variation for Reblozyl in NTD beta thalassemia. Reblozyl is being co-developed and co-commercialized with Merck & Co. (MRK) following Merck's recent acquisition of Acceleron Pharma. These applications were based on safety and efficacy results from the pivotal Phase 2 BEYOND study evaluating Reblozyl plus best supportive care in patients with NTD beta thalassemia.
|Over a week ago|
FDA accepts Bristol-Myers' NDA for deucravacitinib in severe plaque psoriasis » 07:0111/2911/29/21
The company states:…
The company states: "Bristol Myers announced that the FDA has accepted the New Drug Application and the European Medicines Agency has validated the Marketing Authorization Application for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis. The FDA has assigned a Prescription Drug User Fee Act, or PDUFA, goal date of September 10, 2022. These latest regulatory milestones are in addition to the NDA acceptance by Japan's Ministry of Health, Labour and Welfare for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis. The regulatory applications are based on positive results from the pivotal POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once daily deucravacitinib in patients with moderate to severe plaque psoriasis versus placebo and Otezla. Deucravacitinib demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden and quality of life measures compared to placebo and Otezla. Deucravacitinib was well-tolerated with a low rate of discontinuation due to adverse events, with no clinically meaningful lab abnormalities. Primary results were presented at the American Academy of Dermatology Virtual Meeting Experience in April 2021, and additional analyses were presented at the European Academy of Dermatology and Venereology 30th Anniversary Congress in September 2021."
Societe Generale upgrades AbbVie to Buy on better than anticipated execution » 07:4711/2311/23/21
Societe Generale analyst…
Societe Generale analyst Justin Smith upgraded AbbVie (ABBV) to Buy from Hold with a price target of $172, up from $111, telling investors that he sees management executing better than he anticipated on two franchises "crucial to its long-term prospects," immuno-inflammation and aesthetics. AbbVie is replacing Bristol Myers Squibb (BMY) as his preferred value call in global large cap pharma given its improved "long-term replacement power," added Smith, who now has "full conviction" in management's long-term guidance for Allergan's aesthetics franchise following the company's Q3 report.
Bristol-Myers announces Market Authorization in Europe for Zeposia » 07:0111/2311/23/21
Bristol Myers Squibb…
Bristol Myers Squibb announced the European Commission has granted a Marketing Authorization for Zeposia, or ozanimod, for the treatment of adults with moderately to severely active ulcerative colitis, or UC, who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. Zeposia, an oral medication taken once daily, is a sphingosine 1-phosphate, or S1P, receptor modulator that binds with high affinity selectively to S1P subtypes 1 and 5. Zeposia is the first and only oral S1P receptor modulator approved for UC, and represents a new way of treating this chronic immune-mediated disease.
BMO Capital biopharmaceuticals analyst holds analyst/industry conference call » 09:4911/1911/19/21
CADL, GILD, MRTX, PFE, BMY, LLY, INCY, BIIB, AMGN, REGN, NBIX, VRTX, MRK
Biopharmaceuticals Analyst Seigerman discusses his recent initiation of the BioPharmaceuticals Sector with companies CADL, GILD, MRTX, PFE, BMY, LLY, INCY, BIIB, AMGN, REGN, NBIX, VRTX, MRK on an Analyst/Industry conference call to be held on November 19 at 10 am. Webcast Link
Bristol-Myers announces new PDUFA date for mavacamten » 07:0011/1911/19/21
Bristol Myers Squibb…
Bristol Myers Squibb announced that the U.S. Food and Drug Administration has extended the review of the New Drug Application for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy to April 28, 2022. The FDA notified Bristol Myers Squibb on November 18, 2021 of the extension of the PDUFA date to allow sufficient time to review information pertaining to updates to the proposed Risk Evaluation Mitigation Strategy. A REMS program was included in the initial application for mavacamten. No additional data or studies have been requested.
Bristol-Myers initiated with an Outperform at BMO Capital » 16:2011/1811/18/21
BMO Capital analyst Evan…
BMO Capital analyst Evan Seigerman initiated coverage of Bristol-Myers with an Outperform rating and $72 price target. Strong fundamentals, anchored by the company's immuno-oncology and hematology businesses, are not fully reflected in current valuation, nor is Bristol's margin expansion potential, Seigerman tells investors. He views the setup for the shares as favorable relative to U.S. major pharma and large cap biotechnology peers, the analyst added.
J&J expects to file for approval of 14 new drugs by 2025, Reuters reports » 12:0211/1811/18/21
Mathai Mammen, global…
Mathai Mammen, global head of research for Johnson & Johnson's (JNJ) Janssen unit, said that the company anticipates filing for approval of 14 new drugs by 2025 and is projecting average peak sales of $4B a year for each, Reuters' Michael Erman and Julie Steenhuysen report. In particular, Mammen highlighted a drug combination for non-small cell lung cancer, an anticoagulant it is working on with Bristol-Myers (BMY), and a vaccine for respiratory syncytial virus, the authors note. Reference Link