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May 1, 2013
10:45 EDTTHRX, THRX, GSK, GSK, VRX, VRX, DEPO, DEPO, FLML, FLML, CELG, CELG, ONXX, ONXX, FRX, FRX, AVEO, AVEOWashington Analysis healthcare analyst holds analyst/industry conference call
Healthcare Analyst Loss discusses top FDA issues which include upcoming FDA meetings, FDA rules and initiatives and PDUFA dates (THRX, GSK, VRX, DEPO, FLML, CELG, ONXX, FRX and AVEO) on an Analyst/Industry conference call to be held on May 1 at 11 am.
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September 28, 2015
12:49 EDTVRXValeant down 10% after Democrats request subpoena
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12:45 EDTVRXHouse Democrats urge Valeant to turn over documents, Bloomberg says
11:28 EDTVRXValeant mentioned cautiously in a Seeking Alpha article
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10:20 EDTVRXOptions with increasing implied volatility
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08:24 EDTVRXValeant CEO tells employees bear thesis in media incorrect
Valeant Pharmaceuticals disclosed that it distributed a letter today from its CEO Michael Pearson to employees relating to recent changes in Valeant's stock price. The letter stated in part, "A number of you have asked me and other senior members of our management team about the significant drop in our stock price - especially over the past 5 trading days. While the entire pharmaceutical and biotech sector has been impacted by market volatility and numerous press articles about pharmaceutical pricing, we have been hit particularly hard. After talking with a number of investors and observing the concerns and assertions in the media, I thought it would be helpful to give you my perspective on the two main issues worrying investors: 1) Concern that our business model and strategy is dependent upon large price increases in our U.S. pharmaceutical business, 2) Concern around our exposure to U.S. government drug price reimbursement. I can assure you that this bear thesis is incorrect on both accounts...Turning to the first concern about our business model, the majority of our portfolio will continue to deliver strong volume-based organic growth and is not dependent on price increases...Turning to the second concern about proposed changes to government reimbursed products in the U.S., our exposure to U.S. government reimbursement currently represents approximately 15% of our total revenue. Of this, about one third, or ~5%, represents sales to Medicaid, the Department of Veterans Affairs, the Department of Defense, and other government entities, where the business is at best marginally profitable. Despite this, we continue to offer our products through these programs to ensure these patients continue to have access to needed medications. The remaining 10% of our government exposure is related to Medicare. As I stated above, our overall strategy is to focus on private and cash pay markets and to minimize government reimbursement. I believe our exposure to government reimbursement is lower than any other major pharmaceutical company." Shares of Valeant are down 18% over the past five trading days. They closed Friday down $10.18 to $199.32.
07:52 EDTGSKIIR Holdings to hold a conference
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07:46 EDTVRXUBS to hold a field trip
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06:44 EDTDEPODepomed issues statement on ISS report
Depomed (DEPO) issued the following statement regarding a report by Institutional Shareholder Services' on Horizon Pharma's (HZNP) solicitation to call two special meetings of Depomed's shareholders. Depomed commented, "The ISS recommendation does not change the fact that we believe Horizon's offer does not reflect the value inherent in Depomed's business nor Depomed's compelling prospects for long-term growth and value creation, and therefore is not in the best interests of shareholders... We strongly believe Depomed shareholders are being misled by Horizon and are entitled to know the facts. First, based on Friday's closing price of Horizon stock, Horizon's all-stock exchange offer has a current value of only $21.64 per Depomed share, nowhere near the $33.00 a share that Horizon continues to disingenuously tout in its communications to Depomed shareholders. Second, Horizon has misleadingly announced false deadlines to submit proxies. To be clear, Depomed's Board of Directors has set record dates for October 29 and November 13, 2015 and there is no deadline approaching for Depomed shareholders to submit proxy cards to call a special meeting. Moreover, there is absolutely no requirement for Depomed shareholders to take any action until after the October 29 and November 13, 2015 record dates."
September 27, 2015
16:58 EDTGSK, THRXGlaxoSmithKline, Theravance report Phase 3 data on Anoro Ellipta for COPD
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September 25, 2015
16:17 EDTCELGOn The Fly: Top stock stories for Friday
Stocks opened with sharp gains the day after Fed Chair Janet Yellen gave some clarity to the market by suggesting the Fed will most likely raise interest rates by the end of the year. During afternoon trading, the news flow slowed and the volume lightened on the buy side, leaving the sellers with the upper hand. The Nasdaq was the first index to move into negative territory, led by broad weakness in biotech stocks, while the Dow was helped to stay in the green by a big post-earnings move higher in Nike (NKE). The averages limped into the close, leaving the market with an interesting set-up to begin next week. Outside of stock news, it was certainly a headline packed day, as Speaker of the House John Boehner announced that he will resign at the end of October, Chinese President Xi Jinping continued his U.S. visit and Pope Francis addressed the United Nations while spending a second day in New York City. ECONOMIC EVENTS: In the U.S., the third estimate of second quarter GDP showed the economy grew 3.9% quarter-over-quarter, versus expectations for the GDP growth estimate to stay at 3.7%. Personal consumption in Q2 is now believed to have grown 3.6%, up from the prior estimate of 3.1%. The final University of Michigan consumer sentiment reading for September came in at 87.2, which was down from August's 91.9 but above the expected 86.2 reading... Federal Reserve Chair Janet Yellen said during a speech at UMass Amherst last night that the central bank remains inclined to hike rates this year. Yellen's remarks were incrementally hawkish, but welcomed by the market, since they helped clarify the message the Fed delivered a week ago. Of note, the Fed chair paused multiple times toward the end of her speech and received medical attention afterward, but returned to her regular schedule later in the evening, with the bank explaining that Yellen was dehydrated after a long day but was otherwise fine. COMPANY NEWS: Nike jumped $10.23, or 8.9%, to $125.02 after Thursday night's report of better than expected earnings and futures orders prompted numerous price target hikes at Street research firms. Additionally, Sterne Agee upgraded Nike to Buy from Neutral, saying it thinks the company is benefiting from its "global grass roots engagement with its customers," which enables it to meet its customers' needs and determine to what extent it can raise prices. The firm, which thinks that the company is continuing to gain share, has a $150 price target on the athletic gear giant... Biotech stocks, which were already having a bad week, ended the week on a down note, as the iShares NASDAQ Biotechnology Index (IBB) fell 4.9%, giving it a weekly decline of about 13%. Among the biggest large-cap losers in the space were Vertex (VRTX), which fell 7%, Regeneron (REGN), which dropped 6% and Celgene (CELG), which slid 4.8%. MAJOR MOVERS: Among the notable gainers was Jabil Circuit (JBL), which advanced $2.38, or 12.2%, to $21.88 after it reported higher than expected earnings and gave guidance for its November quarter that was significantly above expectations. Also higher was Cirrus Logic (CRUS), which gained $3.90, or 14.4%, to $31.03 after tear downs of Apple's (AAPL) iPhone 6S and 6S Plus led analysts to conclude that the chipmaker appears poised to obtain more revenue from the new devices than from the previous generation of the market-leading smartphone. Among the noteworthy losers was Finish Line (FINL), which fell $4.86, or 19.6%, to $19.91 after reporting second quarter revenue that missed expectations and saying it expects adjusted earnings this fiscal year to increase in a low single to mid single digits percentage from last year. Also lower following its earnings report was smartphone and software maker BlackBerry (BBRY), which slid 7.68% to $6.49 after the company posted a second quarter loss that was steeper than analysts expected. BlackBerry also confirmed press reports that it plans to launch a new phone that uses Google's (GOOG) Android operating system instead of its own proprietary BB10 OS. Shares of Aratana Therapeutics (PETX), which dropped $6.81, or 38.97%, to $10.68 after the company said that, based on "mixed clinical and scientific results," it does not believe that canine lymphoma products AT-004 and AT-005 in their current, first-generation forms will capture the desired lymphoma market opportunity. INDEXES: The Dow rose 113.35, or 0.7%, to 16,314.67, the Nasdaq fell 47.98, or 1.01%, to 4,686.50, and the S&P 500 added/slipped 0.90, or 0.05%, to 1,931.34.
12:38 EDTVRXOptions with increasing implied volatility
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07:22 EDTCELGEuropean Society for Medical Oncology to hold a conference
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05:21 EDTCELGCelgene's VIDAZA receives positive CHMP opinion
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05:11 EDTVRXStocks with implied volatility movement; VRX CAT
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September 24, 2015
11:24 EDTGSKGlaxoSmithKline receives positive CHMP opinion in Europe for Nucala
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11:08 EDTVRXOptions with increasing implied volatility
Options with increasing implied volatility: PTCT CZR KITE HZNP NAV CREE VRX PNK
05:24 EDTTHRX, GSKGlaxoSmithKline and Theravance intend to file Relvar Ellipta for COPD in Japan
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September 23, 2015
13:09 EDTGSKEU could green light GlaxoSmithKline's new asthma drug this week, Reuters says
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08:02 EDTDEPODepomed announces two favorable decisions in review proceedings vs. Endo
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05:32 EDTGSKViiV Healthcare announces Triumeq Phase IIIb study met primary endpoint
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