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April 7, 2014
08:06 EDTBMYBristol-Myers submits NDAs for Daclatasvir and Asunaprevir to FDA
Bristol-Myers Squibb Company has submitted new drug applications with the U.S. Food and Drug Administration for the investigational products daclatasvir, an NS5A replication complex inhibitor, and asunaprevir, a NS3 protease inhibitor. The data submitted in the NDAs support the use of DCV+ASV in patients with genotype 1b hepatitis C. The DCV NDA also seeks approval for use of this compound in combination with other agents for multiple genotypes. The submissions are subject to FDA review for acceptance for filing. These submissions follow the recent announcement that the FDA granted the investigational DCV Dual Regimen Breakthrough Therapy Designation. In 2013, the investigational all-oral 3DAA Regimen also received Breakthrough Therapy Designation, and the company anticipates submitting this regimen for FDA review in Q1 2015.
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July 23, 2014
15:30 EDTBMYNotable companies reporting before tomorrow's open
Notable companies reporting before tomorrow's market open, with earnings consensus, include Ford (F), consensus 36c; General Motors (GM), consensus 58c; Potash (POT), consensus 46c; Caterpillar (CAT), consensus $1.52; 3M (MMM), consensus $1.91; Union Pacific (UNP), consensus $1.43; Bristol-Myers Squibb (BMY), consensus 44c; Eli Lilly (LLY), consensus 65c; Celgene (CELG), consensus 89c; Precision Castparts (PCP), consensus $3.35; Raytheon (RTN), consensus $1.59; Noble Energy (NBL), consensus 79c; Hershey (HSY), consensus 76c; Southwest Airlines (LUV), consensus 61c; Boston Scientific (BSX), consensus 19c; JetBlue (JBLU), consensus 19c.
15:10 EDTBMYBristol-Myers technical comments before earnings
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July 21, 2014
06:43 EDTBMYGrowing market for hepatitis-C treatment prompts legal scramble, WSJ says
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July 17, 2014
08:08 EDTBMYBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
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July 16, 2014
06:26 EDTBMYBristol-Myers lung cancer trials being underestimated, says Citigroup
After building a statistical model of Bristol-Myers' two critical registration trials for Opdivo in lung cancer, Citigroup believes the market is "materially" underestimating both Phase III trials. Citi says potential Opdivo FDA approval in 2015 in lung cancer would give Bristol-Myers an up to two year lead time versus Merck (MRK) and Roche (RHHBY). The firm estimates 2023 Opdivo revenue at $7B and reiterates a Buy rating on Bristol with a $60 price target.
July 15, 2014
11:13 EDTBMYPerrigo retreats after analyst sees limited potential buyers
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07:35 EDTBMYPerrigo potential buyers list could be limited, says Jefferies
After Globes reported that Perrigo retained an investment bank to assist with a potential merger, Jefferies says the list of potential buyers could be limited since the store brand business is fundamentally a high volume, lower margin model. The firm notes U.S. companies that currently do not have large over-the-counter divisions include Bristol-Myers (BMY), Eli Lilly (LLY) and Merck (MRK). Jefferies views the merger speculation surrounding Perrigo as not surprising given the company's strong long-term fundamentals and attractive Irish domicile. It has a Buy rating on the stock with a $160 price target.
July 10, 2014
12:43 EDTBMYBristol-Myers announces plans for Q3 submission of Opdivo BLA
Bristol-Myers Squibb announced earlier that, following discussions with the FDA, the company is planning a Q3 submission of a Biologics Licensing Application for Opdivo for previously treated advanced melanoma. This will mark the second tumor type for which Bristol-Myers Squibb has a regulatory submission underway for Opdivo in the U.S. “We continue to collaborate closely with the FDA on Opdivo and the planned submission in advanced melanoma represents an important step forward in our company’s commitment to deliver innovative treatment options for patients with cancer,” said Michael Giordano, MD, Head of Oncology Development, Bristol-Myers Squibb. The advanced melanoma BLA is based on data from Checkmate -037, a multinational, multicenter, randomized open-label Phase 3 trial evaluating Opdivo compared to dacarbazine or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy and, if BRAF-mutation positive, a BRAF inhibitor regimen. Bristol-Myers Squibb has proposed the name Opdivo, which, if approved by health authorities, will serve as the trade name for nivolumab.

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