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News Breaks
June 24, 2014
16:47 EDTBMYBristol-Myers says Phase 3 study of nivolumab versus dacarbazine stopped early
Bristol-Myers Squibb announced that a randomized blinded comparative Phase 3 study evaluating nivolumab versus dacarbazine in patients with previously untreated BRAF wild-type advanced melanoma was stopped early because an analysis conducted by the independent Data Monitoring Committee showed evidence of superior overall survival in patients receiving nivolumab compared to the control arm. Patients in the trial will be unblinded and allowed to cross over to nivolumab. The company will share these data with health authorities. “The outcome of CheckMate -066 is an important milestone in the field of immuno-oncology as it represents the first well-controlled, randomized Phase 3 trial of an investigational PD-1 checkpoint inhibitor to demonstrate an overall survival benefit,” said Michael Giordano, MD, Head of Oncology Development. “Bristol-Myers Squibb is committed to continuing to lead advances in immuno-oncology and to executing our strategy to provide patients with the best opportunity to achieve the potential for long term survival.” CheckMate -066 investigators have been informed of the decision to stop the blinded comparative portion of the trial. Bristol-Myers Squibb will ensure that patients are informed of the opportunity to continue or start treatment with nivolumab in an open-label extension as part of the company’s commitment to characterize long-term survival. The study, which was designed in consultation with the Committee for Medicinal Products for Human Use, was primarily conducted in countries where DTIC is a commonly-used treatment in the first-line setting, including Canada, but not at U.S. trial sites. The company will complete a full evaluation of the final CheckMate -066 data and work with investigators on the future presentation and publication of the results.
News For BMY From The Last 14 Days
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February 12, 2016
13:55 EDTBMYRBC thinks Intercept values itself more than any bidder can pay
RBC Capital analyst Michael Yee believes Intercept Pharmaceuticals (ICPT) thinks it is worth more than a bidder would be willing to pay at this time. Suitor interest is not surprising given Intercept's pending approval in the summer, but a near-term takeover is unlikely since the FDA hasn't even held a panel meeting for the company's lead drug OCA, Yee tell investors in a research note after Reuters reported that the company received interest and is exploring a possible sale. The analyst thinks Intercept could be synergistic for companies like Gilead (GILD), Merck (MRK), Bristol-Myers (BMY), Sanofi (SNY) and AstraZeneca (AZN). Yee has an Outperform rating on stock with a $300 price target. Intercept is rallying 25%, or $24.07, to $118.36 in afternoon trading.
12:51 EDTBMYIntercept said to explore sale after suitors reportedly come calling
Shares of Intercept Pharmaceuticals (ICPT), which has often been rumored in the past to be a potential takeover target, are surging in afternoon trading after Reuters reported that the company is exploring a potential sale. WHAT'S NEW: Reuters, citing people familiar with the matter, said the company, which focuses on treatments for liver disease, has been working with investment banker advisors to explore a sale after receiving interest from other companies. PRIOR CHATTER: Earlier this week, United Kingdom blog Proactive Investors discussed "reheated rumors" of a takeover of Intercept, which claimed the company was teaming up with CenterView Partners to advise on a sale. It mentioned AstraZeneca (AZN) as a possible suitor now that Shire (SHPG) has reached an agreement to acquire Baxalta (BXLT). On February 2, the U.K.'s Daily Mail said rumors that several big-name pharmaceutical companies were interested in Intercept had been "doing the rounds again," noting that trader chatter pointed to purported interest from Shire, Gilead (GILD), Bristol-Myers (BMY) and Pfizer (PFE). WHAT'S NOTABLE: Yesterday, the FDA issued a notice to announce a forthcoming meeting of the Gastrointestinal Drugs Advisory Committee to discuss the new drug application for obeticholic acid oral tablets submitted by Intercept Pharmaceuticals, proposed for the treatment of primary biliary cirrhosis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. PRICE ACTION: In afternoon trading, Intercept jumped 35% to $127.85 per share. Reference Link
February 8, 2016
07:25 EDTBMYBiotech Industry Organization to hold a conference
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06:28 EDTBMYPharma trade group rolls out ad campaign aimed at lawmakers, WSJ says
The pharmaceutical industry is launching a new ad campaign with the intention of improving its reputation with lawmakers in an effort to lobby against drug price restrictions, the Wall Street Journal reports. The industry's biggest trade group the Pharmaceutical Research and Manufacturers of America, or PhRMA, says it plans to spend several million dollars this year, and 10% more than it spent last year, on digital, radio, and print advertisements that highlight the sector's role in developing new drugs and advancing medical science, the report says. Publicly traded companies in the space include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Reference Link
February 5, 2016
12:48 EDTBMYBristol-Myers announces expanded use of Daklinza approved by FDA
Bristol-Myers Squibb announced today that Daklinza, an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. The expanded label includes data in three additional challenging-to-treat patient populations: chronic hepatitis C virus patients with HIV-1 coinfection, advanced cirrhosis, or post-liver transplant recurrence of HCV. The Daklinza plus sofosbuvir regimen is already available for the treatment of chronic HCV genotype 3, and is currently the only 12-week, once-daily all-oral treatment option for these patients. Sustained virologic response rates are reduced in genotype 3 patients with cirrhosis receiving Daklinza and sofosbuvir for 12 weeks without ribavirin. The recommended dosage of Daklinza is 60 mg in combination with sofosbuvir with or without ribavirin for 12 weeks.
07:37 EDTBMYBristol-Myers pullback brings buying opportunity, says JPMorgan
JPMorgan analyst Chris Schott sees an attractive opportunity for shares of Bristol-Myers following the recent pullback. He reiterates an Overweight rating on the name with an $80 price target. The analyst sees a number of Immuno-Oncology catalysts for shares of Bristol over the next 12-18 months.
February 2, 2016
13:35 EDTBMYEarnings Watch: Merck down over 5% since last earnings report
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09:46 EDTBMYIntercept rumored to draw interest from many suitors, Daily Mail says
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08:53 EDTBMYPiper Jaffray biopharma analyst holds an analyst/industry conference call
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February 1, 2016
06:58 EDTBMYPortola Pharma licensed right to andexanet alfa to Bristol-Myers and Pfizer
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06:57 EDTBMYBristol-Myers and Pfizer sign collaboration with Portola Pharmaceuticals
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