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May 14, 2014
08:35 EDTPBYIPuma Biotechnology expands cohort in Phase II trial of PB272
Puma Biotechnology has expanded the first cohort from its Phase II clinical trial of its lead drug candidate PB272 as a single agent in patients with solid tumors who have an activating HER2 mutation. The cohort that has been expanded is the cohort that includes patients with metastatic breast cancer that is not HER2 amplified or overexpressed and has a HER2 mutation. The Phase II basket trial, which was initiated in October 2013, is an open-label, multicenter, multinational study to evaluate the safety and efficacy of PB272 administered daily to patients who have solid tumors with activating HER2 mutations. The cohorts included in the study are: (1) bladder/urinary tract cancer; (2) colorectal cancer; (3) endometrial cancer; (4) gastric/esophageal cancer; (5) ovarian cancer; (6) EGFR mutated and/or amplified primary brain cancer; (7) solid tumors with a HER3 mutation, and (8) all other solid tumors with a HER2 mutation. The breast cancer patients initially entered the study in the “other solid tumors with a HER2 mutation” basket and due to the preliminary activity seen in the trial the company has expanded the basket, as per the protocol for the trial. The expanded basket will initially enroll a total of 18 patients.
News For PBYI From The Last 14 Days
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July 25, 2014
11:08 EDTPBYIOptions with decreasing implied volatility
Options with decreasing implied volatility: INO PBYI MLNX DECK INFN CMG QLIK LKX ANGI NFLX
July 24, 2014
10:26 EDTPBYIOptions with decreasing implied volatility
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July 23, 2014
17:01 EDTPBYIOn The Fly: Closing Wrap
Stocks began the session mixed and remained that way throughout the trading day, with the Nasdaq the leader and the Dow the laggard. The tech-heavy Nasdaq was helped by a post-earnings rise in shares of Apple (AAPL), while the blue-chip index was weighed down by Boeing's (BA) under-performance following its own quarter report. There was little movement in the averages during the day as they remained in a narrow range, but the increase in the S&P 500 did manage to push it to a new all-time closing high. After the bell, investors will receive the next wave of earnings with AT&T (T), Facebook (FB) and Qualcomm (QCOM) scheduled to report. ECONOMIC EVENTS: In the U.S., MBA's mortgage market index rose 2.4%, with a 0.3% rise in the purchase index and a 4.1% gain in the refinance index for the week ended July 18. Also, the International Monetary Fund predicted that U.S. economic growth for 2014 as a whole will be a disappointing 1.7%. However, barring unforeseen shocks, 2015 growth should accelerate to the fastest annual pace since 2005, propelled by strong consumption growth, a declining fiscal drag, a pickup in residential investment, and easy financial conditions, said the IMF. COMPANY NEWS: Shares of Apple advanced $2.47, or 2.61%, to $97.19 after reporting third quarter earnings that beat expectations. However, the iPhone maker's revenue came in a bit short of analyst expectations for its just completed quarter and its guidance for sales in the new quarter was also below expectations. Piper Jaffray analyst Gene Munster said Apple's September quarter guidance suggests an iPhone 6 launch on September 26, versus the firm's prior expectation for a September 19 launch. Piper views Apple's Q3 results as removing the last major variable ahead of the iPhone and iWatch launches later this year and reiterates an Overweight rating on the stock. Another research firm, Janney Capital, said Apple did not address rumored new products, like the iPhone 6 and iWatch, on its earnings call, but did indicate that its wider than normal revenue guidance range was due to "many moving pieces," suggesting one or two new products may be introduced, but late in the quarter... Dow component Boeing sank $3.03, or 2.34%, to $126.71 despite reporting "core" EPS that beat expectations and raising its fiscal year earnings outlook to a range above the Wall Street consensus. Boeing's revenue missed expectations, however, and it also reported its total company backlog of $440B was unchanged from the beginning of the quarter... Another Dow member, McDonald's (MCD), fell 92c, or 0.96%, to $95.35 after the company reported weaker than expected second quarter results yesterday and its stock was downgraded by at least five research firms. MAJOR MOVERS: Among the notable gainers was Puma Biotechnology (PBYI), whose stock surged $174.40, or 295.44%, to $233.43 after the company reported positive data for its breast cancer drug and an analyst at Citigroup said that the company would probably become a takeover target. Also higher was Intuitive Surgical (ISRG), which rose $69.47, or 17.71%, to $461.63 and was upgraded at both Raymond James and Stifel after the company reported better than expected Q2 results. Among the noteworthy losers was Xilinx (XLNX), which tumbled $6.89, or 14.31%, to $41.26 after the company reported lower than expected first quarter revenue and forecast that its sales could drop as much as 4% in Q2 versus Q1. After the report, analysts at William Blair, Bank of America Merrill Lynch and BMO Capital all downgraded the stock. Also lower were shares of Juniper Networks (JNPR), which fell $2.39, or 9.63%, to $22.43 and was also downgraded at Bank of America Merrill Lynch after its Q3 guidance missed expectations. INDEXES: The Dow slid 26.91, or 0.16%, to 17,086.63, the Nasdaq rose 17.68, or 0.4%, to 4,473.70, and the S&P 500 gained 3.48, or 0.18%, to 1,987.01.
12:17 EDTPBYIOn The Fly: Midday Wrap
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11:08 EDTPBYIHigh option volume stocks
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10:05 EDTPBYIPuma Biotechnology seen as takeover target after positive data
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09:17 EDTPBYIOn The Fly: Pre-market Movers
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07:48 EDTPBYIPuma Biotechnology price target raised to $300 from $144 at Leerink
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07:47 EDTPBYIPuma Biotechnology price target raised to $325 from $125 at UBS
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06:32 EDTPBYIPuma Biotechnology a likely acquisition target after data, says Citigroup
Citigroup raised its price target for Puma Biotechnology shares to $292 from $99 after the company announced positive Phase III data for its investigational breast cancer drug neratinib. Citi views Puma as a likely acquisition target saying the drug is likely to work in lung cancer and potentially other HER2mut cancers while the company has patent protection until 2030. The firm thinks Puma could be worth $291-$351 per share in a takeout scenario and keeps a Buy rating on the stock.
06:25 EDTPBYIPuma Biotechnology volatility is expected to move on positive top line results
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July 22, 2014
18:33 EDTPBYIOn The Fly: After Hours Movers
UP AFTER EARNINGS: Broadcom (BRCM), consensus up 3% after reporting second quarter results... Intuitive Surgical (ISRG), up 10.4%... Manhattan Associates (MANH), up 3%... Robert Half International (RHI), up 3.9%... Hawaiian Holdings (HA), up 3.1%... Microsoft (MSFT), up just under 1%... FMC Technologies (FTI), up 1.1%. ALSO HIGHER: Ballard Power Systems (BLDP), up 2.7% following purchase order from New Flyer Industries... Unwired Planet (UPIP), up 2.4% after filing a lawsuit against Microsoft for breach of contract. NOTABLE: Puma Biotechnology (PBYI), up 193.8% after reporting positive top line results from Phase III PB272 trial. DOWN AFTER EARNINGS: Xilinx (XLNX), down 8.7%... Apple (AAPL), down after reporting third quarter results and fourth quarter guidance... Juniper Networks (JNPR), down 4.7%... ALSO LOWER: Farmland Partners (FPI), down 3.8% after filing to sell 3.72M shares of common stock.
16:45 EDTPBYIPuma Biotechnology up 200% after positive top line PB272 trial results
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16:27 EDTPBYIPuma Biotechnology reports positive top line results from Phase III PB272 trial
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16:18 EDTPBYIPuma Biotech now responsible for R&D expenses associated with legacy trials
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July 15, 2014
14:35 EDTPBYIPuma Biotechnology volatility elevated
Puma Biotechnology August call option implied volatility is at 138, September is at 113 December is at 95; compared to its 26-week average of 98 according to Track Data, suggesting large near term price movement.

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