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News Breaks
January 9, 2014
08:38 EDTBMY, VRTXVertex announces first data from initial cohorts of VX-135 Phase 2a study
Vertex Pharmaceuticals (VRTX) announced the first data from the initial cohorts of an open-label Phase 2a study of VX-135 in combination with daclatasvir, Bristol-Myers Squibb's (BMY) NS5A replication complex inhibitor. In an intent-to-treat analysis, the sustained viral response rate four weeks after the completion of treatment was 83% in treatment-na´ve genotype 1 patients who received 200 mg of VX-135 in combination with daclatasvir. In this arm, one patient discontinued treatment after the first dose due to a serious adverse event of vomiting/nausea. The 11 other patients in this arm completed 12 weeks of treatment, and 91 percent (10 of 11) achieved SVR4. In the study, the majority of adverse events were mild. Vertex expects to submit data to present at a medical meeting in 2014.
News For VRTX;BMY From The Last 14 Days
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February 5, 2016
09:26 EDTVRTXLeerink biotech analyst holds an analyst/industry conference call
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08:03 EDTVRTXVertex says FDA determined it can't approve KALYDECO NDA in present form
Vertex Pharmaceuticals announced that it received a Complete Response Letter from the U.S. Food and Drug Administration for its supplemental New Drug Application for the use of KALYDECO in people with cystic fibrosis ages 2 and older who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator gene. The FDA determined that it cannot approve the application in its present form. Vertex plans to meet with the FDA to determine an appropriate path forward. Our intention with this submission was to rapidly bring KALYDECO to additional people with CF who we believe may benefit," said Vertex Executive Vice President and Chief Medical Officer, Jeffrey Chodakewitz, M.D. "We chose to pursue this approach given our strong belief in the science of CF and in the well-established safety of KALYDECO across many different groups of people with CF. We are disappointed by this decision and look forward to discussing with the FDA the next steps to bring KALYDECO to people with CF who have these residual function mutations."
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.
06:06 EDTVRTXVertex resumed with an Outperform at Leerink
Leerink analyst Geoffrey Porges resumed coverage of Vertex Pharmaceuticals with an Outperform rating and $131 price target.
February 4, 2016
19:16 EDTVRTXVertex reinitiated with an Outperform at Leerink
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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
10:00 EDTVRTXOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: Air Products (APD) upgraded to Buy from Neutral at UBS... American Airlines (AAL) upgraded to Outperform from Market Perform at Cowen... Axiall (AXLL) upgraded to Overweight from Neutral at JPMorgan... BASF (BASFY) upgraded to Buy from Hold at Societe Generale... CNH Industrial (CNHI) upgraded to Neutral from Underperform at BofA/Merrill... CU Bancorp (CUNB) upgraded to Outperform from Market Perform at Fig Partners... CaixaBank (CAIXY) upgraded to Hold from Sell at Societe Generale... Chipotle (CMG) upgraded to Neutral from Underperform at BofA/Merrill... Concho Resources (CXO) upgraded to Buy from Neutral at SunTrust... Continental Building (CBPX) upgraded to Buy from Hold at BB&T... Eastman Chemical (EMN) upgraded to Buy from Outperform at CLSA... Extreme Networks (EXTR) upgraded to Buy from Hold at Needham... Glacier Bancorp (GBCI) upgraded to Outperform from Market Perform at Fig Partners... IBERIABANK (IBKC) upgraded to Strong Buy from Outperform at Raymond James... Infineon (IFNNY) upgraded to Buy from Neutral at UBS... Jarden (JAH) upgraded to Outperform from Market Perform at Raymond James... Joy Global (JOY) upgraded to Overweight from Equal Weight at Barclays... KT Corporation (KT) upgraded to Overweight from Neutral at JPMorgan... Kennametal (KMT) upgraded to Neutral from Underperform at BofA/Merrill... L-3 Communications (LLL) upgraded to Buy on valuation at BofA/Merrill... Maximus (MMS) upgraded to Outperform from Market Perform at Raymond James... Micron (MU) upgraded to Neutral from Sell at Goldman... Monster Beverage (MNST) upgraded to Outperform from Market Perform at Wells Fargo... Newell Rubbermaid (NWL) upgraded to Outperform from Market Perform at Raymond James... Northrop Grumman (NOC) upgraded to Buy from Neutral at BofA/Merrill... PTC (PTC) upgraded to Buy from Neutral at Sterne Agee CRT... Peoples Bancorp (PEBO) upgraded to Outperform from Neutral at Boenning & Scattergood... Praxair (PX) upgraded to Buy from Neutral at UBS... Proofpoint (PFPT) upgraded to Outperform from In-Line at Imperial Capital... Seagate (STX) upgraded to Hold from Sell at Benchmark... Siemens (SIEGY) upgraded to Buy from Neutral at Nomura... Superior Drilling (SDPI) upgraded to Buy from Hold at Wunderlich... Vertex (VRTX) upgraded to Buy from Hold at Jefferies... Werner (WERN) upgraded to Strong Buy from Outperform at Raymond James... ZAIS Financial (ZFC) upgraded to Overweight from Equal Weight at Barclays.
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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06:09 EDTVRTXVertex upgraded to Buy from Hold at Jefferies
Jefferies analyst Brian Abrahams upgraded Vertex Pharmaceuticals to Buy saying current share levels provide a good long-term entry point. In the low $90s, the stock reflects an "excessively cautious" case on future label expansions for Orkambi, Abrahams tells investors in a research note. He continues to believe in Vertex's long-term cystic fibrosis sales opportunity. The analyst cut his price target for the shares to $120 from $142. The biotechnology company closed Friday down $2.01 to $90.75.
January 29, 2016
07:49 EDTBMYBristol-Myers, AbbVie receive 'positive' CHMP opinion for Empliciti
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January 28, 2016
12:42 EDTBMYBristol-Myers says EU approves Daklinza for treatment of chronic hepatitis C
Bristol-Myers Squibb announced that the European Commission has approved Daklinza for the treatment of chronic hepatitis C in three new patient populations. The expanded label allows for the use of Daklinza in combination with sofosbuvir in HCV patients with decompensated cirrhosis, HIV-1 coinfection, and post-liver transplant recurrence of HCV in all 28 Member States of the European Union. Daklinza is already approved by the European Commission for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic HCV infection in adults, and the Daklinza + sofosbuvir regimen is the only approved 12-week, all-oral treatment for genotype 3 HCV patients without cirrhosis. The new indications are based on data from the ALLY-1 clinical trial and ALLY-2 clinical trial. The recommended treatment regimens and durations are as follows:
09:27 EDTBMYBristol-Myers reports Q4 US revenue $2.3B
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09:27 EDTBMYBristol-Myers sees FY16 non-GAAP EPS $2.30-$2.40, consensus $2.29
Sees FY16 revenue up in mid-single digit range, consensus $17.4B. Sees FY16 gross margin as percentage of revenue ot be approximately 75%-76%. Sees FY16 marketing, sales and administrative expenses decreasing in mid-single digit range. Sees FY16 R&D expenses increasing in high-single digit range. Sees FY16 effective tax rate between 21%-22%.
09:25 EDTBMYBristol-Myers reports Q4 non-GAAP EPS 38c, consensus 28c
Reports Q4 revenue $4.29B, consensus $4.15B.
07:11 EDTBMYBristol-Myers: DMC concluded that CheckMate Phase 3 study met primary endpoint
07:00 EDTBMYBristol-Myers says CheckMate-141 Opdivo Phase 3 trial stopped early
Bristol-Myers Squibb announced that a randomized Phase 3 study evaluating Opdivo versus investigator's choice in patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck was stopped early because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint, demonstrating superior overall survival in patients receiving Opdivo compared to the control arm. The company looks forward to sharing these data with health authorities soon. "With the results of CheckMate -141, Opdivo moves closer to providing a potential treatment option for patients with head and neck cancer, a cancer with a high unmet need and limited treatment options," said Michael Giordano, M.D., senior vice president, head of Oncology Development, Bristol-Myers Squibb. "We look forward to continuing to advance the Opdivo clinical development program in hard-to-treat cancers, such as head and neck cancer." CheckMate -141 investigators have been informed of the decision to stop the trial early and Bristol-Myers Squibb is working to ensure that eligible patients be provided the opportunity to continue or start treatment with Opdivo as part of the company's commitment to providing patient access to Opdivo, and characterizing long-term survival. The company will complete a full evaluation of the final CheckMate -141 data, and work with investigators on the future presentation and publication of the results.
05:59 EDTVRTXVertex price target lowered to $143 from $180 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff lowered his price target for Vertex Pharmaceuticals to $143 to reflect reduced cystic fibrosis sales assumptions following the company's Q4 results. The analyst says there is "no surprises" in Vertex's quarter and keeps an Overweight rating on the name.
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