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Thursday, May 17, 2018

Wells Fargo employees altered business customers’ information

Some employees in a Wells Fargo & Co unit that handles business banking improperly changed information on documents related to corporate customers, the Wall street Journal reported on Thursday, citing people familiar with the matter.

Wells Fargo’s shares were down 1.4 percent in early trading.
The employees in Wells Fargo’s so-called wholesale unit, which is separate from its retail bank, added or altered information without customers’ knowledge, the Journal reported.
The information added varied from social security numbers to addresses to dates of birth for people associated with business-banking clients, the WSJ reported.
The incident happened in 2017 and early 2018 as Wells Fargo was trying to meet a deadline to comply with a regulatory consent order related to the bank’s anti-money-laundering controls, the report said.
Wells Fargo became aware of the behavior in recent months from employees, according to the Journal.
The bank has reported the problem to the Office of the Comptroller of the Currency and the agency is probing the problem, the WSJ said, citing a person familiar with the matter.
The bank, smarting from a prolonged sales scandal in its retail banking business, is still leading to probes by regulators.

Immunomedics has positive breast cancer med data

Sacituzumab Govitecan Produced Overall Response Rate of 31 Percent in Patients Post Endocrine Treatment with a Manageable Safety Profile
Full Data will be Reported in Oral Presentation at 2018 American Society of
Clinical Oncology (ASCO) Annual Meeting
Company to Host Investor Event on June 3, 2018
 Immunomedics, Inc.(IMMU) (“Immunomedics” or the “Company”), a science-based and innovation-focused biopharmaceutical company committed to the development and worldwide commercialization of its unique and proprietary antibody-drug conjugate (ADC) platform, today announced that sacituzumab govitecan, its lead investigational ADC, induced promising objective responses as a single agent in heavily pre-treated patients with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC).
“For women with HR+ metastatic breast cancer relapsing after endocrine treatment, there are currently limited treatment options,” said Aditya Bardia, MD, MPH, Director of Precision Medicine and attending physician at Center for Breast Cancer, Massachusetts General Hospital, Harvard Medical School, Boston, MA and lead author of the abstract. “I am very encouraged with the results of sacituzumab govitecan in this subgroup of patients with metastatic breast cancer.”
As reported in the ASCO abstract released online on May 16th, 2018, sacituzumab govitecan generated a confirmed overall response rate (ORR) of 31 percent in heavily pre-treated ER+/HER2- mBC patients (N = 54), based on local assessment. The six-month clinical benefit rate was 48 percent.
“We are extremely encouraged to see that our unique ADC is showing promise as a treatment for the ER+/HER2- subgroup, providing further evidence in establishing sacituzumab govitecan as a foundational therapy for metastatic breast cancer,” said Dr. Robert Iannone, Head of Research & Development and Chief Medical Officer of Immunomedics.
Sacituzumab govitecan treatment was generally well tolerated, with no treatment-related deaths. Consistent with safety data obtained in metastatic TNBC, grade 3 or 4 toxicity with greater than 10 percent frequency included neutropenia and leukopenia. There was one case of grade 3/4 diarrhea and febrile neutropenia.
Additional findings, including durability of responses and patient sub-group analyses will be presented in an oral session at 9:12 a.m. (Central Time) on Sunday, June 3, 2018 at the ASCO meeting:
  • Efficacy of sacituzumab govitecan (anti-Trop-2-SN-38 antibody-drug conjugate) for treatment-refractory hormone-receptor positive (HR+)/HER2-negative metastatic breast cancer (mBC) (Bardia, et al.)
    Session Title: Breast Cancer – Metastatic
    Abstract # 1004
    9:12 a.m. – 9:24 a.m. (Central Time)
    Hall D2
Investor Event
On June 3, 2018, Immunomedics will host an investor event at 7:30 p.m. Central Time at the McCormick Place Convention Center in Chicago, IL. For additional information and/or to RSVP for the event, please contact Dr. Chau Cheng at ccheng@immunomedics.com. The investor event will be webcast via the Investors page on the Company’s website at https://immunomedics.com/investors/.

Jounce Is Trounced In Experimental Cancer Drugs


Loxo Oncology (LOXO) shares rocketed late Wednesday after the biotech company released data showing its experimental cancer treatment shrunk tumors in nearly 70% of patients regardless of where their cancers originated.
In after-hours action on the stock market, Loxo flew 19% to 166, after losing 0.8% during the regular session and ending at 139.50. Shares of Blueprint Medicines (BPMC), which is making a rival drug, collapsed 13%, near 75.
The drug called LOXO-292 works to correct mistakes in the RET gene. In all, 35 patients had what are known as RET fusion positive tumors, including 27 with advanced lung cancer, seven with papillary thyroid cancer and one with pancreatic cancer. Another 20 had medullary thyroid cancer with RET point mutations.
Of those with RET fusion positive tumors, 69% responded. Tumors shrank in 65% of patients with advanced lung cancer, and in 83% with papillary thyroid cancer. In medullary thyroid cancers, 79% responded. The data is current as of Jan. 5. Since then, they have improved, Loxo said in a news release.
Loxo released the data ahead of the American Society for Clinical Oncology meeting set for early June. Then, Loxo will unveil the improved data with a cutoff date in April.

Jounce Therapeutics Tumbles

Also late Wednesday, Jounce Therapeutics (JNCE) plummeted 27.8%, near 12.80. Jounce said is planning to unveil data from a combination of its drug JTX-2011 with Bristol-Myers Squibb‘s (BMY) Opdivo in a variety of cancers. Bristol shares rose 0.2%, near 52.30.
The Phase 1 and Phase 2 study is looking at the combination across four solid tumors including forms of stomach, breast, head and neck, and lung cancers.
Like Loxo, Jounce published an overview of data online that was current as of Jan. 27. Jounce said it will release updated results June 2. Preliminary data show JTX-2011 is well tolerated alone and in combination with Opdivo, the firm said in a news release.
It also “has demonstrated evidence of biologic activity and tumor reductions in heavily pre-treated patients who have failed all available therapies,” Jounce Chief Medical Officer Elizabeth Trehu said in a prepared statement.

Loxo Oncology’s targeted cancer drug shows promise in early trial


An experimental Loxo Oncology Inc drug that targets cancers with mistakes in the RET gene led to tumor shrinkage in nearly 70 percent of patients regardless of where their cancer originated, according to preliminary data from a small study released on Wednesday.
The drug, LOXO-292, was well tolerated by patients with advanced cancer, many of whom were resistant to or no longer being helped by available treatments, researchers reported.
Loxo shares rose more than 9 percent after the data was released, while shares of Blueprint Medicines, which is developing a rival drug, fell more than 12 percent.
The oral medicine is intended for cancer patients with RET abnormalities in which two genes become fused together, triggering accelerated cancer cell growth.
RET fusions, an acquired rather than inherited gene defect, occur in about 2 percent of lung cancers, 10 to 20 percent of papillary thyroid cancers, and a small number of other cancers. Other mutations known as activating RET point mutations account for about 60 percent of medullary thyroid cancers, which comprise 3 percent of all thyroid cancers.
As of the cutoff date of January 5, data included 35 patients with RET fusion positive tumors, including 27 with non-small cell lung cancer (NSCLC), 7 with papillary thyroid cancer and 1 with pancreatic cancer. Another 20 patients had medullary thyroid cancers with RET point mutations.
In RET fusion positive patients, 69 percent of those who could be evaluated had significant tumor shrinkage, based on standard criteria for overall responses, typically shrinkage by at least a third.
The overall response rate was 65 percent for those with NSCLC, including three whose cancer had spread to the brain, and 83 percent for patients with papillary thyroid cancer.
In patients with medullary thyroid cancers, some 79 percent experienced tumor shrinkage ranging from 9 to 45 percent.
A brief summary of the results was released on Wednesday ahead of next month’s American Society of Clinical Oncology Meeting Chicago, where more detailed data on the study involving more patients will be presented.
Loxo Chief Executive Josh Bilenker, in a call with analysts earlier this month, said he was “encouraged by the data we submitted in January,” but noted that efficacy has improved since January.
The findings follow initial results released at a cancer meeting last month by Blueprint, whose rival RET-targeted drug showed an overall response rate of 45 percent, including 50 percent for NSCLC and 40 percent for medullary thyroid cancers.
Of the 57 patients in the Loxo study, 52 remained on the treatment. Side effects were mostly minor and occurred in about 10 percent of patients. They included fatigue, diarrhea and shortness or breath.

Overcoming Anger and Frustration

Cognitive Behavioral Techniques for Changing Your Trading Psychology - Part Three: Overcoming Anger and Frustration

 
In the first post in this series, we took a look at the cognitive behavioral self-help techniques described in the new book by Dr. Seth Gillihan and how we can overcome our tendencies toward procrastination.  The second post in the seriesexamined the fear of missing out (FOMO) in trading and specific techniques for moving past that fear.  This final installment deals with anger and frustration and methods for ensuring that these do not bias our decision-making.

We typically feel frustrated when we are pursuing a goal and find our path blocked.  If we want to reach a destination and we are slowed by traffic, we can respond to the situation with a flight-or-fight response, cursing the situation.  When the situation becomes more personal--if we believe that someone stands in the way of our achieving our goal--the frustration can become anger and even rage.  We most often experience anger if we believe our rights have been violated; that we have been mistreated or wronged.

In the case of trading, our goal is to make money through our ideas and this goal is often thwarted by the adverse behavior of the market.  We are faced with a loss instead of a gain and this can frustrate us.  If we tell ourselves that other market participants are somehow cheating or gaming the system, our frustration can turn to anger.  Once we're worked up in the flight-or-fight mode, we can make subsequent reactive decisions, turning one loss into many more.

If a core skill of short-term trading is pattern recognition, then success hinges upon a high degree of focus and open-mindedness.  When we lose peace of mind, we lose focus and openness and we trade what we want to see, not what we're actually seeing.

Dr. Gillihan outlines several powerful techniques for moving past frustration and anger, including:

1)  Know your triggers - Typically, there are a limited number of situations that have the power to set us off.  If we are aware of those situations, we can mentally rehearse them and practice calming self-talk.  For example, we can imagine ourselves losing on a trade, feeling frustrated, and then reminding ourselves that any edge in markets is only probabilistic and that losses are part of the game.  This acceptance can help us regroup and generate the next idea.  Self-awareness of triggers can also enable us to step back from trading temporarily when those occur, so that we don't allow frustration to impact our behavior.  One especially powerful technique when a trigger occurs is to remind yourself of the costs of angerand how acting on the trigger has hurt you in the past.  That way, frustrated behavior becomes the problem, not the triggering situation.

2)  Relax and breathe with your anger - If you temporarily lost your faculty of vision, you would not blindly put trades into the market.  The fight or flight response creates emotional blindness, so that you may no longer see yourself or the market clearly.  If you use emotional arousal as a cue to relax and breathe more deeply and regularly, you practice self-control.  Each episode of frustration thus poses an opportunity for you to achieve self mastery.  You can actually engage your competitive instincts and look forward to losses as opportunities to beat anger.  That way, every trade is a winning trade.  You either make money or you build inner strength.

3)  Practice acceptance - It is OK to lose as long as you exercise sound risk management in the sizing and management of your position.  As we recently saw in a post on turning mistakes into trading successes, it is not uncommon for a losing trade to lead you to reassess your view and eventually generate a much better trade idea--often in the opposite direction.  A sound trade that loses can provide useful information.  By accepting the loss as a tuition for learning, we can move past frustration and gain from the lessons learned.  I recently placed a good trade with high odds of taking out a prior market high.  We moved toward the high, stalled, and then started to reverse on higher volume.  I quickly got out of my trade at a small loss and flipped short, accepting that we had likely make the high for the day.  The subsequent down move, trapping the longs, more than made up for the loss on the long position.

We cannot prevent setbacks in life but we can ensure that we use these as sources of learning and development.  Every day can be profitable if we're always using experience to make ourselves better.  Once we realize that setbacks are opportunities, we can actually respond to them with gratitude.  If life is a classroom, our setbacks are our lessons and we can give thanks for the opportunity to grow.
 
https://bit.ly/2rPIovv

Takeda CEO prescribes surgical R&D cuts after $62 billion Shire deal

For Christophe Weber, the boss of Japan’s Takeda Pharmaceutical (4502.T), securing a $62 billion deal last week to buy drugmaker Shire (SHP.L) at the fifth time of asking was the easy bit.
Now he has to steer what will be one of the world’s most indebted drugmakers through the big spending cuts needed to make the financial sums work, without destroying the lifeblood of future innovation.
At the same time he must win shareholders’ support for the largest-ever overseas purchase by a Japanese company – something he told Reuters could be helped by bringing in one or more long-term, large strategic investor.
Talks on this were now starting, he said, but declined to identify the parties involved.
Weber said in a interview that his prescription for a smooth merger was planning, speed and a surgical focus on culling experimental drugs that fail to offer the high level of medical innovation demanded by cash-strapped insurers and governments.
“It’s really important that we don’t waste resource on assets that are moderately innovative. When you combine two pipelines you can be more stringent,” he said in London, where he is meeting investors and analysts.
Takeda will either dispose of programs that don’t make the cut or spin them off into separate biotech companies in which it could retain a stake, the latter being a strategy is has pursued around 10 times in the past, Weber said.
It is a delicate task. For the past decade, ramming together two drugmakers in mega-mergers has been unpopular, following the R&D disruption caused by past deals like Pfizer’s (PFE.N) acquisition of Wyeth in 2009.
Indeed, Frenchman Weber has direct experience of one such deal that fell short of expectations after working at GlaxoSmithKline (GSK.L) when it was formed in 2000 by the combination of Glaxo Wellcome and SmithKline Beecham.
“It’s very important that we keep the momentum and don’t get disrupted,” he said. “We rely on R&D to grow.”

‘LESS DISRUPTIVE’

Takeda struck the agreement to take over London-listed Shire on May 8, a deal that will propel the Japanese company from a mid-size pharma player into the top 10 rankings of global drugmakers by sales, alongside the likes of Novartis (NOVN.S) and Pfizer (PFE.N).
Days later, Weber appointed U.S.-based executive Helen Giza to oversee overall integration of the enlarged group, which will be tightly focused on gastroenterology, neuroscience, oncology, rare diseases and blood-derived therapies.
There is a big cultural divide to bridge. Takeda is a 237-year-old Japanese institution that began life selling traditional Japanese and Chinese herbal medicines, while Shire was born above a shop in southern England in 1986.
But Weber believes he has a key advantage because Shire has been focused on later drug development, rather than early research, so there is no large research center that needs to be closed. “I think it will be much less disruptive than in typical M&A because of the research set-up,” he said.
A key testing ground for the merger will be in Boston, a global hub of life sciences research, where both Shire and Takeda have large teams that must work seamlessly once the deal closes in the first half of 2019.
Takeda has forecast annual cost synergies of at least $1.4 billion three years after the deal closes, including $600 million in R&D costs, achieved by cutting duplication and rationalizing research programs.
Weber said savings would be helped by the fact that R&D investment in certain established Takeda drugs was now winding down. Still, $600 million remains a big bite out of two companies’ current combined R&D spend of $4.4 billion.
“They are cutting quite deep in R&D and it is not clear if the amount of money they are saving is going to be beneficial or harmful,” said John Rountree, a partner at pharmaceutical strategy consulting firm Novasecta.
4502.TTOKYO STOCK EXCHANGE
-18.00(-0.38%)
4502.T
  • 4502.T
  • SHP.L
  • PFE.N
  • GSK.L
  • NOVN.S
“Merging R&D is never easy. There are going to be lay-offs and that creates uncertainty and disruption and sometimes the best talent just leaves.”
Takeda expects to reduce the overall workforce of 52,000 by 6-7 percent, with R&D accounting for just under a third of the cuts. Weber said he recognized the risk of losing key staff and his team was currently working on a staff retention program.

FINANCING FEARS

Many investors have been lukewarm on the Shire deal because of the debt Takeda is taking on and uncertainty over how it will convert a $31 billion bridge loan into long-term financing.
Takeda has promised to bring the net debt of the enlarged group down to two times EBITDA within three to five years, from 4-5 times when the deal closes, and believes it can do this without significant disposals or shareholder dilution.
“In the refinancing mechanism we will use a lot of different instruments but none of them are dilutive,” Weber said.
Weber said he had never doubted he would persuade investors of the case for the transaction but he acknowledged there had been “uncertainty and misunderstanding” initially. More recently, investor comfort with the deal had improved, he said.
The real test will come later this year when Weber will learn if he has secured the necessary two-thirds support needed from Takeda shareholders and three-quarters backing from Shire investors.
One Japanese institutional investor who owns Takeda shares said there were some fears the deal would overstretch Takeda’s finances but the benefit from business synergies should outweigh this. “We hope Takeda will provide a good explanation to the market and ease the investors concerns,” he said.
Adding strategic investors could help alleviate some of those worries, potentially mirroring Bayer’s (BAYGn.DE) recent deal to raise $3.7 billion towards its planned takeover of Monsanto (MON.N) by selling a stake to Singapore’s state investment company Temasek.
“There are multiple possibilities of long-term investors, such as government funds or others,” Weber said. “A long-term, strategic, stable investor would be great for us.”

Ultragenyx Phase 3 study meets primary endpoints

Ultragenyx Pharmaceutical announced that the Phase 3 study of Crysvita met its primary endpoint demonstrating that Crysvita was superior to oral phosphate and active vitamin D in improving rickets in children with X-linked hypophosphatemia, or XLH, after 40 weeks of treatment. The study also showed improvement in important metabolic and functional measures with Crysvita treatment, and a safety profile similar to that observed in other Crysvita pediatric XLH studies. Crysvita is an antibody that blocks fibroblast growth factor 23, or FGF23, a hormone that causes phosphate urinary excretion and suppresses active vitamin D production by the kidney.