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Puma Biotechnology announces “positive” results from Phase III ExteNET trial

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Puma Biotechnology (PBYI) announced the presentation of positive results from the Phase III clinical trial of Puma’s drug neratinib for the extended adjuvant treatment of early stage HER2-positive breast cancer following trastuzumab-based therapy in a proffered paper oral session at the European Society of Medical Oncology 2017 Congress in Madrid, Spain.

#Neratinib was approved by the FDA in July for the extended adjuvant treatment of adult patients with early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX tablets.

The most common adverse reactions were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection.

The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab in patients with early stage HER2-positive breast cancer.

The predefined 5-year invasive disease free survival analysis as a follow-up to the primary 2-year iDFS analysis of the Phase III ExteNET trial was presented.

The ExteNET trial randomized 2,840 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 death for a period of five years after randomization in the trial.

The patient characteristics in the trial were well balanced between the neratinib and placebo arms of the trial. For the 1,420 patients in the neratinib arm of the trial, 1,085 were node positive while of the 1,420 patients in the placebo arm of the trial, 1,084 were node positive.

Additionally, in the neratinib arm of the trial, 816 patients were hormone receptor positive, and in the placebo arm of the trial, 815 patients were hormone receptor positive.

The median time from the last trastuzumab dose to entry into the trial was 4.4 months for the neratinib-treated patients and 4.6 months for the placebo-treated patients. The primary endpoint of the trial was invasive disease free survival.

The results of the trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death versus placebo.

The 5-year iDFS rate for the neratinib arm was 90.2% and the 5-year iDFS rate for the placebo arm was 87.7%. The secondary endpoint of the trial was invasive disease free survival including ductal carcinoma in situ. The results of the trial demonstrated that treatment with neratinib resulted in a 29% reduction of risk of disease recurrence including DCIS or death versus placebo.

The 5-year iDFS-DCIS rate for the neratinib arm was 89.7% and the 5-year iDFS-DCIS rate for the placebo arm was 86.8%. For the pre-defined subgroup of patients with hormone receptor positive disease, the results of the trial demonstrated that treatment with neratinib resulted in a 40% reduction of risk of invasive disease recurrence or death versus placebo.

The 5-year iDFS rate for the neratinib arm was 91.2% and the 5-year iDFS rate for the placebo arm was 86.8%.

For the pre-defined subgroup of patients with hormone receptor negative disease, the results of the trial demonstrated that treatment with neratinib resulted in a hazard ratio of 0.95.

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Equifax Hacked, Shares Tumble

Hackers stole data of 143 Million Americans including Social Security numbers

Equifax Site Hacked, 143 Million people affected. See Stockwinners.com for details

Hackers broke into credit-reporting firm of Equifax Inc. (EFX), possibly accessing personal data from up to 143 million or about two-thirds of the adult population of the U.S., the company disclosed late Thursday.

The hackers had access from mid-May until July of this year, and the breach may have compromised data from 143 million Americans including Social Security numbers, driver’s license numbers and credit card numbers. About 209,000 credit card numbers were exposed as well as “dispute documents with personal identifying information” for 182,000 Americans, the company said in a news release.

Equifax is one of the three largest U.S. credit reporting firms, which analyze detailed financial records of consumers across the world. The firms reports on creditworthiness determine if people can take out loans, get housing, and take jobs. Equifax says that it handles data on more than 820 million consumers, and 91 million businesses around the world.

The company has not found evidence core consumer or commercial credit reporting databases were hacked, but in addition to the U.S. data, hackers accessed data for some Canadian and U.K. residents.

[youtube https://www.youtube.com/watch?v=JARx3E7-BLs?rel=0&controls=0&w=560&h=315]

INSIDERS STOCK SALE

Before the news became public, several executives sold their shares.

According to Bloomberg News, Chief Financial Officer John Gamble sold $946,374 of company’s stock, U.S. Information Solutions President Joseph Loughran made $584,099 and Consumer Information Solutions President Rodolfo Ploder earned $250,458.

In the same filing, Loughran exercised an option to buy 3,000 shares at a price of $33.60.

ANALYSTS REACTION

#Deutsche Bank analyst Kevin #McVeigh believes shares of Equifax (EFX) could close down 10% today after the company disclosed a security breach potentially impacting up to 143M consumers. The stock in premarket trading is down 13%, or $18.72, to $124.00.

The analyst says that while difficult to quantify, his best effort suggests the financial impact could be in the range of $300M-$400M, which reflects the costs for credit monitoring, regulatory fines and penalties. Keith recommends waiting for Equifax shares to settle before accumulating fresh positions. The analyst, however, recommends buying TransUnion (TRU) on any selloff in sympathy to Equifax. He thinks TransUnion could trade down 3%-5% today before rebounding. Keith has a Buy rating on Equifax with a $160 price target.

JPMorgan analyst Andrew #Steinerman recommends buying shares of Equifax should today’s selloff on the data breach exceed 10%.  Important, Equifax’s core credit reporting databases were not impacted, Steinerman tells investors in a research note after speaking to management. The company’s CEO emphasized his belief that the financial impact of this incident will be isolated to the B2C segment, the analyst adds. Steinerman says his conviction in Equifax’s longer term business outlook “remains steadfast.” The analyst keeps an Overweight rating on the shares.

Stifel analyst Shlomo #Rosenbaum said he is not yet changing his estimates for Equifax (EFX) to account for its significant cybersecurity breach due to a lack of clarity, but added that “clearly our and the consensus estimates for 2017 and 2018 are just too high.

” Citing the prior large scale breaches at Target (TGT) and Home Depot (HD) as examples, Rosenbaum said $300M-$325M in gross costs would not be unreasonable for Equifax before accounting for the longer-term reputational impact and affect on existing and future customer relationships. Rosenbaum removed Equifax from the firm’s Select List, but as of now has a Buy rating and $149 price target on the stock.

PRICE ACTION

EFX has a 52-weeks trading range of $110.87 – $147.02. Shares closed at $142.72, last traded at $124.00


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Disney Tumbles on guidance, streaming service, and Irma

Disney slides after CEO comments on guidance, streaming service

This blog was updated with Disney World Closure Information

Disney to end Netflix distribution agreement in 2019. See Stockwinners.com Market Radar for details

During Bank of America Merrill Lynch’s Media, Communications & Entertainment Conference, Disney (DIS) CEO Bob Iger said that he expects the company’s 2017 earnings per share to be roughly in line with last fiscal year, sending the stock into negative territory.

The executive also said Marvel and Star Wars will go exclusively to the company’s upcoming streaming service.

GUIDANCE

Disney CEO Bob Iger expects the company’s fiscal year 2017 earnings per share to be roughly in line with last fiscal year.

In 2016, Disney reported adjusted earnings per share of $5.72, according to Bloomberg data. The consensus estimate for 2017 prior to Iger’s comments today was for 2017 earnings per share of $5.88, according to First Call.

“I think you have to look at the year as being roughly in line with an EPS basis that we delivered in fiscal ’16, and that’s for a few reasons, some, by the way, very topical. We mentioned all the way at the beginning of the year the impact of the NBA, big growth in cost to ESPN on the rights front. We also did not have a big Star Wars movie. […]

HURRICANE  IRMA

In addition to that, we have had some impact already from Hurricane Irma. There, we’ve seen cancellations in Orlando, and we’ve also had to cancel three cruise itineraries and shorten a couple of others. Lastly, there will be some expense us in fiscal ’17 that are tied to the BAMTech acquisition,” the executive said during the media conference.

[youtube https://www.youtube.com/watch?v=Ki6q5KaGqrA?rel=0&controls=0&w=560&h=315]

Walt Disney World to close from Saturday until Tuesday or later – Walt Disney World will begin closing its theme parks from Saturday September 9 and “hopes” to resume normal operations on Tuesday September 12, the company stated in an update on Hurricane Irma posted to its website. 

DISNEY STREAMING SERVICE

During the presentation, CEO Bob Iger also said that Marvel and Star Wars titles will go exclusively to the new Disney streaming platform, a service that is set to launch in late 2019.

“We’re going to launch it in late 2019. We’re doing that for two reasons. First of all, as we exit the Netflix (NFLX) output deal, we don’t get access to our theatrical release movies until the beginning of ’19.  Secondly, we wanted time to actually develop and build up original programming for the platform. So late ’19, we’ll launch a Disney-branded service.

It will have — it will be the output distributor for the theatrical release movies. […] We’ve now decided that we will put the Marvel and Star Wars movies on this app as well. So it will have the entire output of the studio: animation, live action, Disney including Pixar, Star Wars and all the Marvel films,” he explained.

Additionally, it will also have four to five original Disney series as well as three to four exclusive Disney movies. “We are going to make less costly movies that are going to be on our proprietary service,” he said.

ESPN

Discussing the company’s ESPN sports network, Iger pointed out that he expects its own streaming service to launch sometime in the Spring, and that ultimately each user will be able to choose the events and sports he wants to watch.

“We will launch with 10,000 live sporting events that are not currently on ESPN’s linear channels. And those will include Major League Baseball, the National Hockey League, MLS, some other tenants and a lot of college in sports that we own the rights to already. […] It will be an ESPN app that exists today. Today, on that ESPN app, you can watch ESPN’s linear channels live authenticated. That will continue to exist. On top of that in the same app, you’ll be able to subscribe to, let’s call it, a plus service. You’ll be able to subscribe to significantly more sports programming than you get just through the linear channels. […] Over time, I think the way you have to look at this is this will be a sports marketplace platform.

You’ll be able to pick and choose over time what it is you want. It won’t necessarily be a one-size-fits-all. We may launch it that way, but the goal eventually is to create something that the sports fan can essentially use to design what their sports media experience can be,” Iger stated.

PRICE ACTION

On Thursday shares of Disney dropped about 4.4% to $97.06, while Netflix’s stock closed fractionally lower to $179.00.


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