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News Breaks
July 16, 2014
06:26 EDTBMY, MRK, RHHBYBristol-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.
News For BMY;MRK;RHHBY From The Last 14 Days
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September 16, 2014
06:00 EDTBMYBristol-Myers announces Health Canada approval of Yervoy
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September 15, 2014
13:30 EDTMRKMerck announces data from pivotal Phase 3 study for odanacatib
Merck announced data from the pivotal Phase 3 fracture outcomes study for odanacatib in postmenopausal women with osteoporosis. Odanacatib is Merck’s investigational once-weekly cathepsin K inhibitor. In the Long-Term Odanacatib Fracture Trial, odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo. The rates of adverse events overall in LOFT were generally balanced between patients taking odanacatib and placebo. Adjudicated events of morphea-like skin lesions and atypical femoral fractures occurred more often in the odanacatib group than in the placebo group. Adjudicated major adverse cardiovascular events were generally balanced overall between the treatment groups. There were numerically more adjudicated stroke events with odanacatib than with placebo.
September 10, 2014
16:00 EDTMRKOptions Update; September 10, 2014
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13:04 EDTRHHBYRoche unit receives orphan status for lung cancer mutation drug
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September 8, 2014
16:00 EDTMRKOptions Update; September 8, 2014
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07:15 EDTRHHBYIBC Life Sciences to hold a conference
10th Annual Cell Line Development & Engineering Conference to be held in Berkeley, California on September 8-10.
September 5, 2014
16:45 EDTMRK, BMYMarket ends week little changed after mixed economic data
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13:07 EDTRHHBYRoche has a conference call hosted by JPMorgan
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11:17 EDTBMY, MRKBristol-Myers files patent infringement suit against Merck
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08:39 EDTMRKMerck Keytruda sales to reach $5B in 2018, says BMO Capital
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September 4, 2014
15:16 EDTMRKMerck receives accelerated approval of Keytruda
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09:02 EDTMRKMerck's relebactam granted QIDP, fast track designations by FDA
Merck announced that the U.S. Food and Drug Administration has designated relebactam -- previously known as MK-7655 -- the company’s investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product with designated Fast Track status. The QIDP and Fast Track designations apply to intravenous use of relebactam for the treatment of complicated urinary tract infections, complicated intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. Relebactam is an investigational, class A and C, beta-lactamase inhibitor that is being evaluated in combination with imipenem/cilastatin in ongoing Phase 2 clinical trials for the treatment of complicated urinary tract infections and complicated intra-abdominal infections. In preclinical studies, relebactam administered in combination with imipenem/cilastatin demonstrated antibacterial activity against a broad range of Gram-negative and beta-lactam-resistant pathogens. Merck plans to initiate Phase 3 studies with relebactam in combination with imipenem/cilastatin in 2015.
08:02 EDTBMYTeva launches generic Baraclude in U.S.
Teva (TEVA) announces the launch of the generic equivalent to Baraclude tablets in the U.S. Teva was first to file, making the product eligible for 180 days of marketing exclusivity. Baraclude is marketed by Bristol-Myers Squibb (BMY).
07:21 EDTMRKMedidata can obtain major new platform customers, says Stifel
Noting that Medidata (MDSO) partners with Veeva, Stifel believes that a number of Veeva (VEEV) customers could become Medidata platform customers, especially if they already use Medidata for R&D and clinical trial solutions. The firm identifies Merck (MRK), Gilead (GILD), and Teva (TEVA) as companies that may become platform clients for Medidata. Stifel keeps a $55 price target and Buy rating on Medidata.
September 3, 2014
17:25 EDTMRKMerck management to meet with SunTrust
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16:20 EDTRHHBYOn The Fly: Closing Wrap
Stocks on Wall Street began the session in positive territory after Russian President Vladimir Putin said he had an outline for a cease-fire plan for eastern Ukraine and was closing in an agreement. The averages hit their highs shortly after the open and the Nasdaq was the first index to cross into negative territory as it was weighed down by Apple's (AAPL) decline. The market moved in a narrow range as investors anticipated the Fed’s Beige Book report, scheduled for release mid-afternoon. The report was fairly benign and the market limped into the close, with volume remaining light. ECONOMIC EVENTS: U.S. factory orders rose 10.5% in July, which was a bit below the forecast for 11.0% growth. The Fed's Beige Book stated that the pace of growth did not change significantly in any of the central bank's 12 regions during a six week period ended in August compared with the previous six week period. COMPANY NEWS: Shares of Apple retreated $4.36, or 4.22%, to $98.94 after research firm Pacific Crest advised investors to take some profits in the stock. Analyst Andy Hargreaves forecast the percentage of new iPhone users who buy the next version of the device beyond the iPhone 6 is likely to decline versus prior cycles. The stock likely has only limited room to increase, according to Hargreaves, who said he would probably downgrade Apple unless new products that can generate billions of dollars in new operating profit are launched at its September 9 event. MAJOR MOVERS: Among the notable gainers was Infinity Pharmaceuticals (INFI), which surged $4.81, or 44.05%, to $15.73 after the company announced a cancer drug collaboration with AbbVie (ABBV) and a master clinical supply agreement with Roche (RHHBY). Also higher was Mobileye (MBLY), which jumped $3.94, or 9.16%, to $46.97 ahead of its second quarter earnings report, which is due tomorrow morning. Among the noteworthy losers was Repros Therapeutics (RPRX), which fell $4.11, or 18.55%, to $18.05 after FDA briefing documents ahead of a panel on T-normalizing therapies prompted Piper Jaffray to downgrade the stock to Neutral from Overweight. Also lower after its earnings report was apparel company Vince Holding (VNCE), which fell $4.47, or 11.54%, to $34.27. Analysts at Piper Jaffray attributed the post-earnings weakness to investor concerns over heightened inventory levels, but the firm said it still sees Vince as one of the best small cap growth names in its space and would be "aggressive buyers" on the weakness. INDEXES: The Dow edged up 10.72, or 0.06%, to 17,078.28, the Nasdaq fell 25.62, or 0.56%, to 4,572.56, and the S&P 500 slipped 1.56, or 0.08%, to 2,000.72.
12:33 EDTRHHBYOn The Fly: Midday Wrap
Stocks on Wall Street were higher to begin the day, as reports spurred optimism that a ceasefire agreement between Russia and the Ukraine may soon be reached. The move was short lived, as the averages turned mixed during the second hour of trading. Shares of Apple (AAPL) are weighing down the Nasdaq after an analyst recommended investors take some profits in the stock. ECONOMIC EVENTS: In the U.S., factory orders rose 10.5% in July, which was a bit below the forecast for 11.0% growth. The Fed's Beige Book is scheduled to be released at 2:00 pm ET. In Europe, the final reading of Eurozone services PMI was knocked down to 53.1 from a preliminary 53.5 reading, mirroring the lowering of the Eurozone manufacturing PMI reading yesterday. COMPANY NEWS: Shares of Apple retreated 4% after research firm Pacific Crest advised investors to take some profits in the stock. Pacific Crest analyst Andy Hargreaves forecast the percentage of new iPhone users who buy the next version of the device beyond the iPhone 6 is likely to decline versus prior cycles. The stock likely has only limited room to increase, according to Hargreaves, who said he would probably downgrade Apple unless new products that can generate billions of dollars in new operating profit are launched at its September 9 event... Carmakers reported on August vehicle sales in the U.S., with Chrysler (FIATY) reporting a 20% increase, Ford stating that sales rose slightly compared to the prior year and General Motors (GM) posting a 1.2% decline in sales. MAJOR MOVERS: Among the notable gainers was Infinity Pharmaceuticals (INFI), which jumped 46% after the company announced a cancer drug collaboration with AbbVie (ABBV) and a master clinical supply agreement with Roche (RHHBY). Also higher was Mobileye (MBLY), which gained nearly 10% after Morgan Stanley wrote that the stock could rise "towards $100" if the company maintains its current market, gross margins and earnings position. Mobileye is scheduled to report on its second quarter results tomorrow morning, which will be its first quarterly report since its August IPO. Among the noteworthy losers was Repros Therapeutics (RPRX), which dropped 15% after newly posted FDA briefing documents regarding a panel on T-normalizing therapies prompted Piper Jaffray to downgrade the stock to Neutral from Overweight. Also lower following its earnings report was apparel company Vince Holding (VNCE), which fell 11%. INDEXES: Near midday, the Dow was up 33.71, or 0.2%, to 17,101.27, the Nasdaq was down 23.24, or 0.51%, to 4,574.95, and the S&P 500 was down 0.64, or 0.03%, to 2,001.64.
06:48 EDTRHHBYInfinity Pharmaceuticals partners with Roche for blood cancer clinical studies
Infinity Pharmaceuticals (INFI) has entered into a master clinical supply agreement with Roche (RHHBY) under which Roche will supply Gazyva to Infinity for use in planned clinical studies to evaluate the combination of Gazyva and duvelisib, Infinity’s oral inhibitor of phosphoinositide-3-kinase -delta and PI3K-gamma, in patients with hematologic malignancies, or blood cancers. The companies have also entered into a material transfer agreement under which Infinity is supplying Roche with duvelisib for use in Roche’s preclinical and translational research to evaluate the combination of duvelisib and Gazyva.
September 2, 2014
07:12 EDTBMYCredit Suisse names its Top U.S. Pharmaceutical picks for 2H
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07:10 EDTBMYAlder Biopharmaceuticals regains worldwide rights to clazakizumab
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