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November 12, 2012
The averages were lower but not far from their starting point at midday amid light holiday trading volume. The market began the session slightly higher but was unable to gain upside momentum. The averages ultimately crossed into negative territory but have managed to stay in a narrow trading range and remain within striking distance of the flat line... ECONOMIC EVENTS: In the U.S., bond markets and banks are closed in observance of Veterans Day and no economic data was released. Over the weekend in Europe, Greece’s 2013 budget was approved but euro area finance ministers are unlikely to approve the next batch of loans to Greece at their meeting today, according to media reports. In Asia, China’s exports rose 11.6% in October, which was their fastest growth rate since May and exceeded forecasts. Elsewhere in the region, Japan's gross domestic product fell an annualized 3.5% in the three months through September and economists predict the nation’s economy will shrink again in the next quarter, leading to its third technical recession since 2008... COMPANY NEWS: Mergers dominated the domestic headlines, as Leucadia National (LUK) agreed to acquire the remaining 71.4% of Jefferies (JEF) it doesn’t own for about $3.7B, or $17.66 per share, in an all stock transaction. Annaly Capital Management (NLY) struck a deal to pay $12.50 per share for the remaining shares of CreXus (CXS). Also, after Friday's closing bell, Precision Castparts (PCP) announced a deal to buy Titanium Metals (TIE) for $16.50 per share, or $2.9B, a 43% premium to its closing price that day... Two homebuilders, D.R. Horton (DHI) and Beazer Homes (BZH), both declined following their quarterly reports. D.R. Horton's earnings beat consensus and its net sales orders climbed 24% but shares slid 3%. Beazer reported stronger than expected revenue but a wider than expected loss and its shares plunged 15%... MAJOR MOVERS: Among the notable gainers was Sherwin-Williams (SHW), which rose 6% following its agreement to buy privately held Comex for $2.34B to gain a bigger presence in Mexico. Also higher were shares of Sarepta Therapeutics (SRPT), which climbed over 13% after a JMP Securities analyst said a Duchenne muscular dystrophy treatment developed by GlaxoSmithKline (GSK) that will compete with Sarepta's eteplirsen is unlikely be approved until 2014 or 2015. Among the noteworthy losers were Clovis Oncology (CLVS), down more than 35% after a trial of one of its drugs failed to meet its primary or secondary endpoints, and Achillion Pharmaceuticals (ACHN), down almost 12% after its competitor Gilead (GILD) reported positive hepatitis C virus data... INDICES: Near noon, the Dow was down 22.64, or 0.18%, to 12,792.75; the Nasdaq was down 5.78, or 0.20%, to 2,899.09; and the S&P 500 was down 1.97, or 0.14%, to 1,377.88.
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November 16, 2015
10:23 EDTCLVSClovis price target cut to $28 from $92 at Piper Jaffray
Piper Jaffray analyst Charles Duncan cut his price target for shares of Clovis Oncology (CLVS) to $28 from $92 after the company announced that rociletinib efficacy data matured and the number of patients with a confirmed response is lower than expected. The updated response rate may still ultimately be approvable, but it further hinders rociletinib's competitive positioning compared to AstraZeneca's (AZN) Targrisso, Duncan tells investors in a research note. The analyst pushed back his first rociletinib sales estimate to Q4 of 2016 and lowered the drug's peak penetration of the second line market from 25% to 45%. He reiterates a Neutral rating on Clovis. The stock is down 67%, or $66.93, to $32.50 in morning trading.
10:11 EDTCLVSHigh option volume stocks
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09:19 EDTCLVSOn The Fly: Pre-market Movers
HIGHER: Nexvet Biopharma (NVET), up 16.8% after NV-01 study meets primary endpoint... Protalix BioTherapeutics (PLX), up 4.8% after announcing that it will conduct a Phase III clinical trial for PRX-102... Array Biopharma (ARRY), up 4.3% after announcing a commercialization collaboration with Pierre Fabre... Perrigo (PRGO), up 2.1% after being upgraded to Buy from Neutral at UBS. DOWN AFTER EARNINGS: Dillard's (DDS), down 11.7% after reporting quarterly results. ALSO LOWER: Clovis Oncology (CLVS), down 71.3% after the FDA requested additional clinical data for rociletinib... KaloBios Pharmaceuticals (KBIO), down 48.9% after announcing that it will wind down its operations... Starwood Hotels (HOT), down 6.3% after announcing that Marriott (MAR) will acquire the company... Marriott is down 2.4%... Five Below (FIVE), down 3.1% after being downgraded to Hold from Buy at Deutsche Bank.
09:10 EDTCLVSClovis volatility elevated into FDA requests added data for rociletinib
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09:04 EDTGILDGilead says Phase 3 Zydelig study shows 'clinical benefit'
Gilead announced that its Phase 3 Study 115 evaluating Zydelig added to standard therapy in previously-treated chronic lymphocytic leukemia patients will be unblinded early. The DMC recommendation is based upon a predefined interim analysis indicating a statistically significant benefit in efficacy for progression-free survival and overall survival in patients receiving Zydelig plus bendamustine and rituximab, compared to those receiving only bendamustine and rituximab. The safety profile of Zydelig was consistent with prior studies. Detailed results from this study will be presented during a late-breaking abstracts session at the Annual Meeting of the American Society of Hematology in Orlando, Florida taking place December 5-8. "The clinical benefit observed in this Phase 3 study adds to the body of evidence demonstrating the potential of Zydelig-containing treatment regimens for patients with previously treated CLL," said Norbert W. Bischofberger, PhD, Gilead's Executive Vice President, Research and Development and Chief Scientific Officer. "We look forward to sharing the detailed scientific data with the hematology community at the upcoming ASH meeting."
08:32 EDTCLVSClovis reopens, down 64% after FDA requests added data for rociletinib
AstraZeneca (AZN), which is at work on a drug similar to rociletinib, is up 2.5% in pre-market trading.
08:13 EDTCLVSClovis to resume trading at 8:30 am ET
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08:01 EDTCLVSClovis says FDA requests additional data for rociletinib
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07:57 EDTCLVSClovis shares halted, news pending
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07:16 EDTSRPTFDA likely feels compelled to approve at least one DMD drug, says Leerink
Leerink analyst Joseph Schwartz says the FDA likely feels compelled to approve at least one of the exon skipping drugs to treat Duchenne muscular dystrophy in this review cycle. There is so much public attention and vocal demand in the DMD community, Schwartz tells investors in a research note. The FDA advisory panel on BioMarin's (BMRN) drisapersen is on November 24 while the panel on Sarepta's (SRPT) eteplirsen is tentatively scheduled for January 22, 2016. The greatest likelihood is that both drugs are approved, Schwartz contends. Shares of BioMarin have "significant" upside potential on a positive panel vote as many investors still doubt that drisapersen is approvable based on existing data, and approval would "greatly aid" the company's goal to reach profitability, the analyst argues. He reiterates an Outperform rating on BioMarin and a Market Perform rating on Sarepta. Jefferies analyst Eun Yang said on Friday that regulatory experts she spoke with see a high likelihood of a positive FDA panel vote BioMarin.
November 15, 2015
20:17 EDTGILDGilead presents results from four Phase 3 studies of sofosbuvir/velpatasvir
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15:47 EDTGILDGilead reports data from multiple studies of Viread, TAF, others
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12:59 EDTPCPBaker Hughes shares could gain, lose 30% on merger verdict, Barron's says
Shares of Baker Hughes (BHI) could gain 27% if its combination with Halliburton (HAL) gains regulatory approval, but "there is too much uncertainty" to take that bet, as a negative verdict on the merger could send Baker plunging 20%-30%, Barron's contends in a 'Trader Extra' column. Investors searching for less risky arbitrage deals may instead take a look at Berkshire Hathaway's (BRK.A, BRK.B) offer for Precision Castparts (PCP), argues the publication. Reference Link
November 13, 2015
15:32 EDTSRPTSarepta CEO says having BioMarin go first with AdCom is an advantage
Sarepta (SRPT) interim CEO Edward Kaye said BioMarin (BMRN) having to go first with its advisory committee meeting for its own DMD drug will allow Sarepta time to assess the committee's comments and questions on their drug and formulate responses. Kaye is speaking on CNBC.
10:16 EDTPCPOptions with decreasing implied volatility
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09:37 EDTCLVSClovis down 3% after FDA approves AstraZeneca lung cancer drug
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07:57 EDTSRPTExperts see positive FDA panel for BioMarin, says Jefferies
Jefferies analyst Eun Yang says regulatory experts she spoke with see a high likelihood of a positive FDA panel vote BioMarin's (BMRN) Kyndrisa, a treatment for Duchenne Muscular Dystrophy. The panel meeting is November 24 and the FDA action date for the drug is December 27. The experts point to a favorable risk/benefit profile for Kyndrisa as well as no current treatment option for DMD as supporting their confidence of FDA approval, Yang tells investors in a research note. The experts see a post-marketing study for Kyndrisa as likely necessary, she adds. On competitor Sarepta's (SRPT) DMD treatment eteplirsen, experts' views are "somewhat mixed," Yang adds. She has a Buy rating on BioMarin with a $166 price target. A positive panel vote could boost shares by 20% and bring increased confidence in BioMarin's three additional candidates targeting additional DMD patients, she contends. The orphan drug developer closed yesterday down $4.35 to $106.80.
November 12, 2015
17:55 EDTGILDGilead announces FDA approval of Harvoni
Gilead Sciences announced that the U.S. FDA has approved Harvoni for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus infection and in patients co-infected with HIV. In addition, Harvoni plus ribavirin for 12 weeks was approved as an alternate therapy to 24 weeks of Harvoni for treatment-experienced, genotype 1 patients with cirrhosis. Harvoni received regulatory approval for the treatment of chronic HCV genotype 1 infection in adults in the United States in October 2014.
16:20 EDTLUKE-Trade, Jefferies announce retail alliance
E-Trade Financial (ETFC) and Jefferies, a wholly-owned subsidiary of Leucadia (LUK), announced a retail alliance to provide E-Trade customers with access to Jefferies' underwritings of municipal securities. Through this relationship, E-Trade customers have access to offerings originated by the Jefferies Municipal Securities platform. This builds on both firms' current alliance, in which E-Trade customers have access to Jefferies' underwritings of U.S. IPO and follow-on equity offerings, in place since January 2014.
November 11, 2015
07:41 EDTBZHUBS to hold a conference
Building & Building Products Annual CEO Conference is being held in New York on November 11 with webcasted company presentations to begin at 9:30 am; not all company presentations may be webcasted. Webcast Link
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