Mazor reported earnings of ($0.03) per share miss views

Mazor Robotics (NASDAQ:MZOR) reported 6/30/2018 earnings this Morning, coming in at ($0.03) per share, missing Wall Street’s estimates of ($0.01) per Share. Revenue for the quarter came in at $13.20 million missing the streets estimates of $17.02 million

Mazor Robotics Ltd., together with its subsidiaries, engages in the development, production, and marketing of medical devices for supporting surgical procedures in the fields of orthopedics and neurosurgery in the United States and internationally. It operates in the field of computer assisted surgery that enable the use of surgical instruments with high precision and minimal invasiveness and that simplifies complex surgical procedures.

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Fitbit’s ‘Test’ Will Come In The Second Half, Says Bearish BofA

Fitbit Inc FIT 8.26% reported a second-quarter earnings beat Wednesday afternoon, but the “real test” for the maker of fitness trackers and watchers is still ahead, according to Bank of America Merrill Lynch.

The Analyst

Analyst Ryan Goodman maintained an Underperform on Fitbit with a price target lifted from $4.80 to $5.25.

The Thesis

Fitbit’s newest Versa smartwatch is proving to be a “big win” for the company, as it shipped more than 1 million devices and sold out during the recent quarter, Goodman said in a Thursday note. (See the analyst’s track record here.)

Despite recent momentum in the quarter, Fitbit only reiterated its 2018 revenue guidance of $1.5 billion, which will create some debate among investors ahead of the holiday shopping season, the analyst said.

Fitbit faces a big test ahead with two potential outcomes, Goodman said: Fitbit’s momentum and reinvigorated brand strength creates a “halo effect” that supports a new product launch in the fall. On the other hand, the company is ramping production of its devices, but stabilization in the fitness tracking market “remains to be proven,” and the ability to expand its smartwatch portfolio without cannibalization is uncertain, he said.

BofA’s revised $5.25 price target is based on a 0.4 multiple on 2019 estimated EV/S, which is a discount to the device manufacturer peer group of two times, the analyst said. The valuation discount is justified given Fitbit’s continuing revenue and profitability decline, he said.

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The Importance Of Your Self-Talk

What goes through your mind during trading hours?

How do you talk to yourself?

All of us coach ourselves via self-talk.  What kind of coach are you?

I recently placed a trade looking for a market bounce.  The bounce was feeble and we began to sell off.  I said to myself, “If the bulls are going to be in control, this shouldn’t be happening.”  I quickly hit out of my position and reversed it.  The small loss on the long position was more than exceeded by the gain on the sale.

The trade was only possible because I had rehearsed an alternate scenario during my preparation of what to do if the market could not hold key upside levels.  Through that alternate scenario, I was able to react to the market weakness without shock or surprise.  It didn’t even feel like a losing trade.  It felt like, “OK, it’s time for Scenario B.”

Notice that the self-talk was not about being wrong.  It was not frustrated; it was not discouraged.  A well-thought out trade that doesn’t work can provide useful information.  It’s tuition for some useful learning.

So it is throughout life.  It’s always important to have a Scenario B, and view setbacks as learning lessons.  That means taking the ego out of the trade and viewing everything as information.  It isn’t about positive thinking or negative thinking.  It’s recognizing that it’s not about you.  It’s amazing how we can trade with peace of mind when we are market focused and not self-focused.

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Drugs for heart failure are still under-prescribed, years after initial study

A UCLA-led study found that many people with heart failure do not receive the medications recommended for them under guidelines set by the American College of Cardiology, American Heart Association and Heart Failure Society of America.

The research also found that doctors frequently prescribe medications at doses lower than those recommended by the guidelines, especially for older people, those with kidney disease, those with worsening symptoms or those who were recently hospitalized for heart failure. Further study is needed to determine why people in those four groups specifically were prescribed lower-than-recommended doses.

The study, which looked at the three categories of heart failure medications, found that between 27 percent and 67 percent of patients were not prescribed the recommended drugs. And when patients did receive the medications, they were generally at a lower-than-recommended dose. Less than 25 percent of patients simultaneously received all three medication types, and only 1 percent received the target doses of all three medication types.

About 5.7 million people in the United States have heart failure, according to a 2016 report by the American Heart Association. Heart failure is associated with a lower quality of life and frequent hospitalizations, and it contributes to more than 300,000 deaths each year in the U.S. In half of people with heart failure, the disease is caused by a weak heart muscle that prevents the heart from ejecting a normal amount of blood with each heartbeat, a condition called reduced ejection fraction.

Several medications have been proven in large clinical trials to help people with heart failure and reduced ejection fraction live longer and feel better. Research conducted between 2007 and 2009 showed that many patients were not receiving the recommended doses of these medications. The new study sought to determine if there have been improvements in prescribing practice as well as which patients are most likely to receive less medication than recommended.

The study included 3,518 patients from 150 primary care and cardiology practices who were enrolled in the Change the Management of Patients with Heart Failure registry, or CHAMP-HF, a study of adult outpatients who were diagnosed with heart failure with reduced ejection fraction.

The results suggest that use and dosing of heart failure medications has not improved over the past decade. The report says new strategies are needed to more effectively achieve and maintain recommended doses of heart failure medications and that there is a substantial opportunity to improve dosing of heart failure medications, which would improve the care and outcomes for people with heart failure.

The study’s senior author is Dr. Gregg Fonarow of the David Geffen School of Medicine at UCLA. The first author is Dr. Stephen Greene of Duke University. Other authors are listed in the journal article.

The study appears in the July 24 issue of the Journal of the American College of Cardiology.

The study was supported by Novartis Pharmaceuticals. Greene has received funding from Novartis. Fonarow has consulted for Amgen, Bayer and Novartis. (Amgen, Bayer and Novartis either market heart failure medications or are developing such drugs.) Other authors’ disclosures are listed in the journal article.

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Story Source:

Materials provided by University of California – Los Angeles Health Sciences. Note: Content may be edited for style and length.

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Journal Reference:

1. Stephen J. Greene, Javed Butler, Nancy M. Albert, Adam D. DeVore, Puza P. Sharma, Carol I. Duffy, C. Larry Hill, Kevin McCague, Xiaojuan Mi, J. Herbert Patterson, John A. Spertus, Laine Thomas, Fredonia B. Williams, Adrian F. Hernandez, Gregg C. Fonarow. Medical Therapy for Heart Failure With Reduced Ejection Fraction. Journal of the American College of Cardiology, 2018; 72 (4): 351 DOI: 10.1016/j.jacc.2018.04.070

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Novel drug could potentially treat liver cancer more effectively

A research team led by scientists from the Cancer Institute of Singapore (CSI Singapore) at the National University of Singapore (NUS) has developed a novel peptide drug called FFW that could potentially stop the development of hepatocellular carcinoma (HCC) or primary liver cancer. This landmark discovery opens door for more effective treatment of liver cancer with less side effects.

The international team comprises researchers from Brigham and Women’s Hospital at Harvard Medical School, the Department of Biological Sciences under the NUS Faculty of Science, as well as the Agency for Science, Technology and Research.

HCC is a fast-growing cancer of the liver, and patients typically survive 11 months after diagnosis. HCC accounts for over 90 per cent of all liver cancers and poses a major public health problem in the Asia Pacific region. The main first-line treatment for HCC is the drug Sorafenib, which has adverse side effects and prolongs survival for only three months. The lack of effective treatment alternatives, coupled with late discovery, has led to HCC becoming the second leading cause of cancer deaths worldwide.

SALL4 — a protein related to tumour growth — has been widely studied as a prognosis marker and drug target for HCC and other cancers such as lung cancer and leukemia. It is usually present in the growing fetus but is inactive in adult tissue. In some types of cancer, such as HCC, SALL4 is reactivated, leading to the growth of tumours. However, SALL4 has previously been classified as an ‘undruggable target’.

Novel peptide with robust anti-tumour properties

Drug molecules which act on protein interactions like SALL4-NuRD often require the target proteins to have a small ‘pocket’ in their 3D structure where the drug molecule can reside and take effect.

“In our earlier research, we found out that the SALL4 protein works with another protein, NuRD, to form a partnership that is crucial for the development of cancers such as HCC. Instead of looking for ‘pockets’ on SALL4, our research team designed a bio-molecule to block the interaction between SALL4 and NuRD. In our lab experiments, blocking this interaction has led to tumour cell death and reduced movement of tumour cells,” explained Professor Daniel Tenen, Director of CSI Singapore.

He added, “This exciting discovery has important implications for treatment of HCC. Our work could also be beneficial to a broad range of solid cancers and leukaemic malignancies with elevated SALL4.”

The research team also discovered that FFW, when used in combination with Sorafenib, could reduce the growth of Sorafenib-resistant HCC.

While most targeted therapies are small-molecule drugs, a well-designed peptide drug — such as FFW — tends to possess higher selectivity over large binding surfaces with a safer toxicity profile compared with small molecules.

Dr Liu Bee Hui, Research Fellow at CSI Singapore, said, “Based on the information we gained from structural and global gene expression, we are continuing our work on this peptide and other peptides with similar structures, with the aim of eventually being able to make them into clinical grade drugs for the benefit of patients.”

New approach in cancer therapeutics

The targeting of the SALL4-NuRD interaction as a cancer-cell-specific target represents an exciting avenue for development of therapeutic options.

“An ideal cancer target should be cancer-specific and non-toxic to normal tissues. To this end, we are collaborating to find a missing link that can cure cancer and restore normal cell function,” explained Associate Professor Li Chai from Brigham and Women’s Hospital at Harvard Medical School.

The research team utilised a creative and innovative integrated approach, combined with structural analysis techniques, to act on protein interactions like SALL4-NuRD. The collaborative effort led to the design of the peptide FFW, which is a small chain of amino acids that can interfere with SALL4-NuRD interactions. FFW could effectively block the huge protein-protein interaction surface and does not require a ‘pocket’ to take effect.

“In our latest work, the research team has also demonstrated an effective strategy to accurately target oncogenes previously considered undruggable. Moving forward, we hope to investigate how the targeting of these protein interactions might pan out in other cancer types,” Prof Tenen said.

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Story Source:

Materials provided by National University of Singapore. Note: Content may be edited for style and length.

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Journal Reference:

1. Bee Hui Liu, Chacko Jobichen, C. S. Brian Chia, Tim Hon Man Chan, Jing Ping Tang, Theodora X. Y. Chung, Jia Li, Anders Poulsen, Alvin W. Hung, Xiaoying Koh-Stenta, Yaw Sing Tan, Chandra S. Verma, Hong Kee Tan, Chan-Shuo Wu, Feng Li, Jeffrey Hill, Joma Joy, Henry Yang, Li Chai, J. Sivaraman, Daniel G. Tenen. Targeting cancer addiction for SALL4 by shifting its transcriptome with a pharmacologic peptide. Proceedings of the National Academy of Sciences, 2018; 115 (30): E7119 DOI: 10.1073/pnas.1801253115

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Why weight loss produces remission of type 2 diabetes in some patients

Cross sectional MRI images are displayed with pixels colour-coded for fat content. In this individual, the high liver fat at baseline (30.4 percent) decreased to 1.3 percent after weight loss. The lower panels, at the level of the pancreas …more

A clinical trial recently showed that nearly half of individuals with type 2 diabetes achieved remission to a non-diabetic state after a weight-loss intervention delivered within 6 years of diagnosis. Now a study published August 2nd in the journal Cell Metabolism reveals that this successful response to weight loss is associated with the early and sustained improvement in the functioning of pancreatic beta cells. This finding challenges the previous paradigm that beta-cell function is irreversibly lost in patients with type 2 diabetes.

“This observation carries potentially important implications for the initial clinical approach to management,” says senior study author Roy Taylor of Newcastle University. “At present, the early management of type 2 diabetes tends to involve a period of adjusting to the diagnosis plus pharmacotherapy with lifestyle changes, which in practice are modest. Our data suggest that substantial weight loss at the time of diagnosis is appropriate to rescue the beta cells.”

According to the World Health Organization, diabetes affects approximately 422 million people worldwide. Approximately 90% of cases are type 2 diabetes, a condition in which the body does not produce enough or respond properly to insulin. This hormone, produced by beta cells in the pancreas, helps a sugar called glucose in the blood enter cells in muscle, fat, and liver to be used for energy. Type 2 diabetes has long been considered a lifelong condition that worsens over time.

This traditional view was recently challenged by results from the United-Kingdom-based Diabetes Remission Clinical Trial (DiRECT) overseen by Taylor. The participants, who were diagnosed with type 2 diabetes within 6 years of the start of the study, were randomly assigned to best-practice care (control group) or an intensive primary-care-led weight-management program (intervention group). One year later, 46% of the individuals in the intervention group successfully responded to weight loss in that they recovered and maintained control over blood glucose concentrations. Some non-responders simply had not lost enough weight, but in those who had, it was not clear how their response differed from that of responders.

To address this question, Taylor and his collaborators examined potentially relevant metabolic factors, such as liver fat content, pancreatic fat content, blood concentrations of fats called triglycerides, and beta-cell function, in a subset of DiRECT participants, including 64 individuals in the intervention group. They found that responders to the weight loss program were similar to non-responders before the intervention but had a shorter duration of diabetes (2.7 years vs. 3.8 years). Both responders and non-responders had lost comparable amounts of weight, leading to similar reductions in liver fat content, pancreatic fat content, and blood concentrations of triglycerides.

However, only the responders demonstrated early and sustained improvement in beta-cell function. In particular, the most striking difference between responders and non-responders was the first-phase insulin response. Pancreatic beta cells secrete insulin in two phases in response to an increase in blood glucose concentration. The first phase, which consists of a brief spike lasting approximately 10 minutes, is typically absent in patients with type 2 diabetes. First-phase insulin secretion increased in responders after weight loss but did not change in non-responders.

Taken together, the findings suggest that weight loss normalizes fat metabolism in all individuals with type 2 diabetes, but the more rapid loss of the capacity of beta cells to recover prevents some individuals from returning to a non-diabetic state. However, 98% of the participants were white, so additional studies are needed to assess the generalizability of the results. Moreover, the participants were evaluated for only 12 months of weight maintenance, so longer-term studies are underway.

“The knowledge of reversibility of type 2 diabetes, ultimately due to re-differentiation of pancreatic beta cells, will lead to further targeted work to improve understanding of this process,” Taylor says. “This provides a major focus for cell biologists to make specific advances.”

 Explore further: New potential target for treatment of diabetes

More information: Cell Metabolism, Taylor et al.: “Remission of Human Type 2 Diabetes Requires Decrease in Liver and Pancreas Fat Content but Is Dependent upon Capacity for Beta Cell Recovery” http://www.cell.com/cell-metabolism/fulltext/S1550-4131(18)30446-7 , DOI: 10.1016/j.cmet.2018.07.003

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Simple factors that can avoid harmful side effects in type 2 diabetes

Clinicians can match people with type 2 diabetes to the right drug for them to improve control of blood sugar and help avoid damaging side-effects, simply by factoring in simple characteristics such as sex and BMI into prescribing decisions, new research has shown.

The study, by the University of Exeter Medical School, could dramatically improve benefits of drugs and reduce the risk of potentially harmful side-effects such as weight gain and hypoglycaemia, at no additional cost to the NHS.

Metformin is the first line of drug treatment in type 2 diabetes, but many patients will eventually need additional drugs on top of Metformin to lower their blood sugar levels. Currently, clinicians have to make prescribing decisions on these additional drug options based on limited available guidance. Recent research involving the Exeter team has revealed there is great regional variation across the UK in the prescribing of these additional drugs.

The new study, funded by the Medical Research Council and published in the journal Diabetes Care, provides a starting point for a more evidence-based approach to the prescribing of drugs after Metformin. Based on a patients’ gender and BMI, the authors found important differences in the likely success of the commonly-prescribed drugs sulfonylureas and thiazolidinediones in lowering blood sugar levels, and in the risk of common side effects. For example, obese females were far more likely to have good blood glucose control on thiazolidinediones than sulfonylureas, whilst non-obese males had the opposite result—they were far more likely to have good blood glucose control on sulfonylureas than thiazolidinediones.

The Exeter team used anonymous data from more than 29,000 patients who had either taken part in trials or were treated in UK GP practices. By combining these datasets, the researchers were able to show their findings are robust and potentially applicable to many of the 3.5 million-plus people currently diagnosed with type 2 diabetes in the UK.

John Dennis, of the University of Exeter Medical School, was lead author on the study. He said “Our findings are important as they provide the first evidence that personalised or ‘precision’ medicine approaches in diabetes can be based on simple patient characteristics available to any doctor, rather than expensive genetics or other technology. This simple personalised approach could be implemented immediately within the NHS without any additional cost.

The study is also a powerful demonstration of how the sharing of patient data can meaningfully benefit patients—in this case helping to make sure individual patients get the best drug for them.”

Professor Andrew Hattersley, a Consultant in Diabetes at the Royal Devon and Exeter Hospital and Research Professor at the University of Exeter Medical School said: “At the moment, clinicians are in the difficult position of making decisions that impact on health in type 2 diabetes based on very little evidence. Now, we can create clear guidelines to enable much more informed conversations about what these treatments will mean for people, in order to get better health outcomes and avoid harmful side effects.”

Dr. Richard Evans, Programme Manager for Stratified Medicine and Molecular Pathology at the MRC, said: “This research used shared clinical trial data from a large number of patients to show that simple patient characteristics can help inform the choice of therapy in diabetes; the results are likely to show real impact, and significant benefits to patients when they are implemented in patient care.

“Diabetes afflicts one in 17 people in the UK—research into precision or stratified approaches to this condition is crucial to getting patients the most appropriate treatment in the most efficient way, underpinned by solid evidence.”

The full paper, ‘Sex and BMI alter the benefits and risks of sulfonylureas and thiazolidinediones in type 2 diabetes: A framework for evaluating stratification using routine clinical and individual trial data’, is published in Diabetes Care.

 Explore further: Switching to certain antidiabetic drugs linked to increased risk of major complications

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