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Stock Market & Financial Investment News

News Breaks
July 22, 2014
16:27 EDTPBYIPuma Biotechnology reports positive top line results from Phase III PB272 trial
Puma Biotechnology announced top line results from the Phase III clinical trial of Puma's investigational drug PB272 for the extended adjuvant treatment of breast cancer, or ExteNET Trial. The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab in women with early stage HER2-positive breast cancer. More specifically, the ExteNET trial enrolled 2,821 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ, or DCIS, or death for a period of two years after randomization in the trial. The primary endpoint of the trial was disease free survival, or DFS. The results of the trial demonstrated that treatment with neratinib resulted in a 33% improvement in disease free survival versus placebo. The hazard ratio was determined to be 0.67 which was statistically significant with a p-value of 0.0046. The secondary endpoint of the trial was disease free survival including ductal carcinoma in situ, or DFS-DCIS. The results of the trial demonstrated that treatment with neratinib resulted in a 37% improvement in disease free survival including ductal carcinoma in situ versus placebo. The hazard ratio was determined to be 0.63 which was statistically significant with a p-value of 0.0009. Based on these results from the ExteNET study, Puma plans to file for regulatory approval of neratinib in the extended adjuvant setting in the first half of 2015.
News For PBYI From The Last 14 Days
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May 19, 2015
07:28 EDTPBYIUBS to hold a conference
Global Healthcare Conference is being held in New York on May 18-20 with webcasted company presentations to begin on May 19 at 8 am; not all company presentations may be webcasted. Webcast Link
May 14, 2015
16:19 EDTPBYIOn The Fly: Top stock stories for Thursday
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12:49 EDTPBYIOn The Fly: Top stock stories at midday
The market opened higher amid lower than expected weekly jobless claims, data showing that producer prices fell rather than rose in April and a continued slide in the dollar against the euro. The Dow notched triple digit gains right out of the gate and the averages have moved in a narrow range in morning trading, albeit at near-record levels. ECONOMIC EVENTS: In the U.S., initial jobless claims fell 1K to 264K in the week ended May 9, versus expectations for 273K first-time claims. The weekly data brought the four week moving average to 271.75K, which marks its lowest level in 15 years. The Producer Price Index fell 0.4% in April, with the core PPI reading sliding 0.2%, which missed expectations for both the headline and core PPI figures to have grown 0.1%. After dropping 1.3% yesterday against the euro, the U.S. dollar slid another 0.4% earlier to about $1.14 per euro, bringing its decline to about 7% versus the euro in the past month. COMPANY NEWS: Shares of Avon Products (AVP) were volatile after "PTG Capital Partners" announced via a filing with the SEC that it has submitted an offer to the board of Avon proposing to acquire all of the company's outstanding stock, and outstanding options to acquire such shares, in a recommended cash tender offer at a price per share of $18.75. Shares of Avon spiked initially after the filing, were halted several times due to volatile trading, and came well off their earlier highs as investors questioned the validity of the firm making the purported offer. A source told Dow Jones that the company was treating the purported bid as a hoax and Avon told CNBC that it had no proof PTG exists and that it has not received any offer. Still, Avon remained up about 4% to trade near $6.92 per share in early afternoon trading. MAJOR MOVERS: Among the notable gainers was Russia's QIWI (QIWI), which jumped 12% after the company announced that it has entered into an agreement with Otkritie to acquire the Contact money transfer system and the Rapida payment processing system, which are "highly value accretive" acquisitions according to analysts at JPMorgan. Also higher was China's Ctrip.com (CTRP), which gained 10% and was upgraded at Stifel and Oppenheimer following the company's Q1 results. Among the noteworthy losers was Puma Biotechnology (PBYI), which dropped 18% after data on the company's neratinib drug was disclosed via an abstract for the company's upcoming presentation at the American Society of Clinical Oncology, or ASCO, meeting. Also lower following its earnings report was retailer Kohl's (KSS), which slid over 12%. INDEXES: Near midday, the Dow was up 170.23, or 0.94%, to 18,230.72, the Nasdaq was up 55.96, or 1.12%, to 5,037.65, and the S&P 500 was up 17.10, or 0.81%, to 2,115.58.
10:09 EDTPBYIIncreasing equity options volume on open
Increasing equity options volume on open: ONTY CBRL PBYI GWW AXLL IEV KSS EXPR UEC JACK
09:22 EDTPBYIOn The Fly: Pre-market Movers
UP AFTER EARNINGS: Perry Ellis (PERY), up 11.5%... Ctrip.com (CTRP), up 13.4%. ALSO HIGHER: AcelRx (ACRX), up 10.3% after being awarded contract worth up to $17M from Defense Dept to advance ARX-04... Oncothyreon (ONTY), up 16.9% after ASCO presentation data released... CYREN (CYRN), up 14.6% after announcing agreement with Dell.... Discovery Laboratories (DSCO), up 5.2% after Aerosurf shows positive Phase 2a data... Kate Spade (KATE), up 3.9% after being initiated with an Outperform at Wedbush. DOWN AFTER EARNINGS: Digital Ally (DGLY), down 16.4%... Kohl's (KSS), down 10.2%... VOXX (VOXX), down 8.1%... Cosi (COSI), down 7.3%. ALSO LOWER: Biotechnology (PBYI), down 15.1%% after Neratinib data published in ASCO abstract... Gevo (GEVO), down 10.7% after 4.3M share Spot Secondary priced at $4.00.
09:20 EDTPBYIPuma Biotechnology data look strong, says Leerink
Leerink says that after close examination, the data in Puma Biotechnology's ASCO abstract for neratinib's adjuvant study ExteNET look strong. The firm notes that unlike the HERA trial for Herceptin which enrolled only centrally confirmed HER2-positive breast cancer patients, approximately 80% of Puma's ExteNET patients were confirmed to be HER2+ upon central testing. When focusing on these patients, the magnitude of benefit for neratinib improved, Leerink says. It estimates disease free survival including ductal carcinoma in situ difference at two years to be 4.5%. The firm keeps an Outperform rating on Puma amid today's selloff.
08:09 EDTPBYIPuma Biotechnology volatility elevated into release of four abstracts
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07:52 EDTPBYIPuma Biotechnology data positive, says RBC Capital
RBC Capital believes that the data on Puma's neratinib drug indicates that it has strong efficacy, and additional benefits compared with prior trials. The firm expects investors and medical professionals to have a greater appreciation of the drug's benefits once all of the data on the drug is presented at ASCO. RBC keeps a $285 price target and Outperform rating on the shares.
07:11 EDTPBYIOptions expected to be active
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May 13, 2015
19:12 EDTPBYIOn The Fly: After Hours Movers
UP AFTER EARNINGS: Paragon Offshore (PGN), up 10.3%... Shake Shack (SHAK), up 10%... Vipshop Holdings (VIPS), up 6.7%. ALSO HIGHER: Vascular Biogenics (VBLT), up 12.8% and Oncothyreon (ONTY), up 15.5% after release of ASCO presentation data. DOWN AFTER EARNINGS: Identiv (INVE), down 10.3%... Sphere 3D (ANY), down 11.3%... VOXX International (VOXX), down 8.1%. ALSO LOWER: Puma Biotechnology (PBYI), down 21.8% after Neratinib data published in ASCO abstract... Karyopharm Therapeutics (KPTI), down 1.2% after ASCO presentation data released... Gevo (GEVO), down 11.4% after filing to sell common stock and warrants.
18:37 EDTPBYIBiopharmaceutical stocks volatile after release of ASCO presentation data
After the market close, the American Society of Clinical Oncology, or ASCO, provided public access to 5,000 cancer drug trial research abstracts ahead of the society's 51st annual meeting from May 29 to June 2 in Chicago, Illinois. In after-hours trading, a number of biopharmaceutical stocks were active, including Vascular Biogenics (VBLT) and Oncothyreon (ONTY), which rose 13% and 14.9%, respectively, and Puma Biotechnology (PBYI) and Karyopharm Therapeutics (KPTI), which fell 23.9% and 14.8%, respectively.
17:47 EDTPBYIPuma Biotechnology down 24% after Neratinib data published in ASCO abstract
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May 11, 2015
17:02 EDTPBYIPuma Biotechnology reports Q1 EPS ($1.02), consensus ($1.35)
Net cash used in operating activities for the first quarter of 2015 was $50.0 million. At March 31, 2015, Puma had cash and cash equivalents of $155.5 million and marketable securities of $154.9 million, compared to cash and cash equivalents of $38.5 million and marketable securities of $102.8 million at December 31, 2014. Puma's current level of cash and cash equivalents and marketable securities includes net proceeds of approximately $205.0 million from a public offering of the Company's common stock, which was completed in January 2015.

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