Sage Therapeutics soars on its depression drug

Sage Therapeutics reports ‘positive’ results from Phase 2 trial of SAGE-217

Sage Therapeutics announces results from Sage-217

Sage Therapeutics (SAGE) announced positive top-line results from the Phase 2, double-blind, placebo-controlled clinical trial of SAGE-217 in the treatment of 89 adult patients with moderate to severe major depressive disorder.

In the trial, treatment for 14 days with SAGE-217 was associated with a statistically significant mean reduction in the Hamilton Rating Scale for Depression 17-Item total score from baseline to Day 15 (the time of the primary endpoint) of 17.6 points for SAGE-217, compared to 10.7 for placebo (less than 0.0001).

Statistically significant improvements were observed in the HAM-D compared to placebo by the morning following the first dose through Week 4 and the effects of SAGE-217 remained numerically greater than placebo through the end of follow-up at Week 6. At Day 15, 64 percent of patients who received SAGE-217 achieved remission, defined as a score of 7 or less on the HAM-D scale, compared with 23 percent of patients who received placebo (p=0.0005).

Other secondary endpoints were all similarly highly significant at Day 15 (less than or equal to 0.002). SAGE-217 was generally well-tolerated with no serious or severe adverse events; the most common adverse events in the SAGE-217 group were headache, dizziness, nausea, and somnolence.

A low rate of discontinuations due to AEs was reported; overall reports of AEs were similar between drug (53%) and placebo (46%), with a safety profile consistent with that seen in earlier trials. SAGE-217 was granted Fast Track Designation by the U.S. FDA in May 2017.

PRICE ACTION

SAGE has a 52-weeks trading range of $44.55 – $100.50. Shares closed at $91.90. It last traded at $145 in pre-market trading.


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Madrigal Pharmaceuticals shares sharply higher on its liver drug

Madrigal’s MGL-3196 achieves primary endpoint in Phase 2 clinical trial

Madrigal Pharmaceuticals shares sharply higher. See Stockwinners.com
Madrigal Pharmaceuticals NASH drug reports positive results

Madrigal Pharmaceuticals (MDGL) announced positive top-line results from a Phase 2 clinical trial in patients with biopsy-proven non-alcoholic steatohepatitis. In this trial, MGL-3196, a first-in-class, oral, once-daily, liver-directed, thyroid hormone receptor beta -selective agonist, demonstrated statistically significant results for the primary endpoint, the percent change in hepatic fat versus placebo as measured by MRI-PDFF, a non-invasive imaging test.

Nonalcoholic fatty liver disease (NAFLD) is a condition in which fat builds up in your liver. Nonalcoholic steatohepatitis (NASH) is a type of NAFLD. If you have NASH, you have inflammation and liver cell damage, along with fat in your liver.

Recent published data have shown a high correlation of the reduction of liver fat of 30% or more as measured by MRI-PDFF to improvement in NASH on liver biopsy.

Statistically significant reductions in ALT and AST were observed in MGL-3196 treated patients; greater reductions in ALT and AST, statistically significant relative to placebo, were observed in the prespecified group of 44/78 patients with relatively higher MGL-3196 drug levels.

In drug-treated relative to placebo patients, statistically significant improvements were also seen in multiple secondary endpoints considered to be potentially clinically relevant in patients with NASH including LDL-C, triglycerides, apolipoprotein B, and Lp(a).

MGL-3196 has been well-tolerated with mostly mild AEs, and a few moderate AEs, the numbers of which are balanced between placebo and drug-treatment groups.

There are no adverse effects of MGL-3196 on safety laboratory or vital sign parameters. There have been three serious adverse effects in the study, all considered unrelated to MGL-3196.

The on-going study remains blinded. Safety, efficacy of NASH resolution by biopsy, and repeat MRI-PDFF will be assessed at 36 weeks. Multiple inflammatory and fibrosis serum biomarkers at 12 and 36 weeks are being and will be assessed.

PRICE ACTION

MDGL closed at $43.90. It last traded at $68.20 in pre-market.


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DaVita sold or $4.9 billion

Optum to acquire DaVita Medical Group for approximately $4.9B in cash

 Optum to acquire DaVita Medical Group for approximately $4.9B in cash. See Stockwinners.com
Optum to acquire DaVita Medical Group for approximately $4.9B in cash

Optum, part of UnitedHealth Group (UNH), and DaVita Medical Group, a subsidiary of DaVita (DVA), are combining.

The agreement, entered into on December 5, calls for Optum to acquire DaVita Medical Group for approximately $4.9B in cash.

The transaction is expected to close in 2018 and is subject to regulatory approval and other customary closing conditions.

Following the transaction, DaVita Medical Group will become part of Optum’s OptumCare division, which works with more than 80 health plans to serve millions of consumers annually through 30,000 affiliated physicians and hundreds of care facilities.

DaVita’s medical unit had been a significant drag on the company’s financial performance in recent quarters.

The company said it would use the proceeds from the sale for stock buybacks after the deal closes next year, and to repay debt.

Joe Mello, COO of DaVita Medical Group, will continue in a leadership role in the combined entity, as will the DaVita Medical Group leadership team.

DaVita plans to use the proceeds from the transaction for significant stock repurchases over the one to two years following the closing of the transaction, as well as to repay debt and for general corporate purposes.

DVA closed at $60.93. It last traded at $68.29.


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Better Botox is coming

Revance says RT002 met primary, secondary endpoints in SAKURA trials

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Better Botox coming

Revance Therapeutics (RVNC) announced its next-generation neuromodulator Daxibotulinumtoxin for Injection, or RT002, delivered “positive” top-line results in alleviating moderate-to-severe glabellar lines in two pivotal SAKURA Phase 3 trials.

RT002 appeared generally safe and well-tolerated in both studies. If approved by the U.S. Food and Drug Administration, Revance believes RT002 would be the first neuromodulator with a long-acting duration of six months.

Marketed neuromodulators have demonstrated duration of three to four months in treating glabellar lines.

Both SAKURA 1 and SAKURA 2 met the primary composite endpoint by delivering highly statistically significant improvement against placebo in reducing the severity of glabellar lines, i.e., the frown lines or wrinkles between the brows.

The percent of RT002-treated patients who had none or mild wrinkles and achieved at least a two-point improvement from baseline on both validated physician and patient assessments were 73.6 percent in SAKURA 1 and 74.0 percent in SAKURA 2 compared to placebo at Week 4.

Also at that time point, 88 percent of RT002-treated patients in SAKURA 1 and 91 percent of RT002 patients in SAKURA 2 said they were very satisfied or satisfied with their treatment experience.

All secondary endpoints measuring reduction in severity of glabellar lines with RT002 compared to placebo were highly statistically significant at every time point evaluated to 24 weeks.

On an additional key secondary endpoint, median duration for patients treated with RT002 to return to baseline wrinkle severity was nearly 27 weeks as assessed by both physicians and patients.

In addition to SAKURA 1 and SAKURA 2, a long-term safety trial, SAKURA 3, is fully enrolled and is expected to be completed in the second half of 2018.

Assuming successful completion of SAKURA 3, the company plans to submit a Biologics License Application in the first half of 2019 and, pending approval by the FDA, launch RT002 in the U.S. in 2020.

Shares of Allergan (AGN) are sliding in pre-market trading following the news. If approved by the U.S. FDA, Revance believes RT002 would be the first neuromodulator with a long-acting duration of six months, the company said. The company plans to submit a Biologics License Application in the first half of 2019 and, pending approval by the FDA, launch RT002 in the U.S. in 2020, it added.

RVNC closed at $26.00, it last traded at $33.75.


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Pfizer may buy Bristol-Myers

Senate tax bill raises odds of Pfizer buying Bristol-Myers, says Citi

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Pfizer may buy Bristol-Myers

The Senate tax bill, which lowers the cost of bringing cash back home from outside the U.S., increases the probability of the “often-discussed” potential acquisition of Bristol-Myers Squibb (BMY) by Pfizer (PFE), Citi analyst Andrew Baum tells investors in a research note.

The analyst points out that Pfizer has repeatedly underscored the importance of tax reform both from a competitive angle as well as from a merger perspective.

Further, the analyst says that while Roche’s (RHHBY) IMpower 150 Tecentriq lung cancer data in Geneva will take center stage this week, Bristol-Myers should benefit from two recent positive developments.

The FDA’s and Centers for Medicare and Medicaid Services’ recommendation of Tumor Mutational Burden testing for lung cancer and other tumors will likely materially accelerate adoption and create more favorable reimbursement, Baum writes in a research note partially titled “Stars Converging for BMY.”

The analyst keeps a Buy rating on Bristol shares with a $72 price target. BMY closed at $62.47. PFE ended at $36.06.

On a separate front,  Bristol-Myers Squibb Co.’s blockbuster drug Opdivo had a stunning effect on a lung-cancer patient treated at a Paris hospital: it drained hard-to-reach reservoirs of his HIV infection, too.  The 51-year-old man, who was diagnosed with HIV in 1995, had a “drastic and sustained decrease” in the reservoir of cells where the virus hides to evade existing therapies, researchers wrote in a letter published in the journal Annals of Oncology.

Note that Bristol has a market cap of $102 billion while Pfizer’s market cap is $215 billion.


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Ford to launch 50 new vehicles in China

Ford confirms plans to launch 50 new vehicles in China by 2025

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Ford to launch 50 new vehicles in China.

“China is not only the largest car market in the world, it’s also at the heart of electric vehicle and SUV growth and the mobility movement,” said Bill Ford.

“The progress we have achieved in China is just the start. We now have a chance to expand our presence in China and deliver even more for customers, our partners and society.” Added Hackett: ”

Ford’s (F) aspiration is to become the world’s most trusted mobility company, designing smart vehicles for a smart world.

We are very excited to see this vision come to life in China.”

To enable future growth in China, Ford will contain structural cost in the region throughout 2018, aiming to generate greater efficiencies, become more operationally fit and deliver additional value to shareholders.

Even as the team works to streamline, Ford plans to grow its China revenue by 50 percent by 2025 versus 2017 and is focusing its business expansion on three areas: even more smart, connected vehicles; closer connections to Chinese customers, and a streamlined business structure.

The company plans to offer more than 50 new Ford and Lincoln vehicles in China by 2025.

The expanded product portfolio will reflect an even stronger emphasis on SUVs – with eight all-new utilities, along with more electric vehicles.

The company will launch at least 15 new electrified vehicles from Ford and Lincoln. And the new Zotye-Ford joint venture will deliver a separate range of affordable all-electric under a new brand, pending regulatory approvals.

Plus, by the end of 2019, 100 percent of new Ford and Lincoln-badged vehicles in China will be connected through either embedded modems or plug-in devices.

Company leaders also are working on broader infrastructure opportunities to improve future mobility experiences.

In 2019, the company starts producing five additional Ford and Lincoln models in China for Chinese customers, including a new Lincoln premium SUV, and the company’s first global fully electric small SUV.

Ford is strengthening ties with its joint venture partners Changan and Jiangling in 2018, establishing one distribution services division responsible for the marketing, sales and services associated with all Ford vehicles sold in China.

The new distribution services division will seek to offer a simplified, improved and consistent customer experience for all Ford customers in China.

Ford (F) closed at $12.63.


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Ra Pharmaceuticals tumbles on data, downgrade

RA Pharma slides after data as analyst voices competitive concerns

RA Pharma slides after data as analyst voices competitive concerns
RA Pharma slides after data as analyst voices competitive concerns

Ra Pharmaceuticals (RARX) announced that its RA101495 SC for the treatment of paroxysmal nocturnal hemoglobinuria met the primary endpoint in the Eculizumab native cohort in a clinical trial.

However, Piper Jaffray analyst Christopher Raymond argued that the data “underwhelms on efficacy” in comparison to Alexion’s (ALNX) Soliris.

TRIAL RESULTS

Ra Pharmaceuticals has announced interim results from the company’s ongoing, global Phase 2 clinical program evaluating RA101495 SC for the treatment of paroxysmal nocturnal hemoglobinuria.

RA101495 SC met the primary endpoint in eculizumab naive patients. In these patients, a rapid, robust, and sustained reduction in lactate dehydrogenase levels from baseline to the mean of Weeks 6-12 and near-complete suppression of complement activity were observed.

Interim results from the ongoing switch cohort demonstrate near complete, sustained, and uninterrupted inhibition of complement activity during and after eculizumab washout. In the U.S.-based cohort of inadequate responders to eculizumab, who have a history of elevated LDH, 3 patients have been enrolled.

LDH stabilization and relief of side effects associated with eculizumab intolerance have been observed in the first patient enrolled in this cohort. Across all cohorts, no meaningful safety or tolerability concerns have been identified after more than 300 patient weeks of cumulative exposure, the company reported.

DATA ‘UNDERWHELMS’ COMPARED TO SOLIRIS

Piper Jaffray‘s Raymond told investors that he believes the paroxysmal nocturnal hemoglobinuria data from RA Pharmaceuticals “underwhelms on efficacy” in comparison to Alexion’s Soliris “and for that matter” ALXN1210.

Noting that inferior efficacy to Soliris on its own should put the threat from Ra Pharmaceuticals to bed, he reminded investors nonetheless that ALXN1210 should raise the bar from a convenience standpoint.

The analyst added that he sees “little reason to fret” at this point over the competitive threat to Alexion from RA101495, and reiterated an Overweight rating and $170 price target on Alexion’s shares.

RA PRICE TARGET UPPED

Meanwhile, his peer at BMO Capital raised his price target for RA Pharmaceuticals to $34 from $31, while reiterating an Outperform rating, after its RA101495 demonstrated clinical benefit in all three cohorts in the ongoing Phase 2 trial.

Analyst M. Ian Somaiya told investors in a research note of his own that he believes the phase 3 design is rational and likely to succeed.

Commenting on the potential impact on Alexion, the analyst noted that positive ‘1495 data supports his view that ALXN1210 Phase 3 results need to maintain if not raise the high efficacy and safety bar set by Soliris.

Data from Phase 1/2 trials in the first half of 2018 of Roche (RHHBY)/Chugai’s C5 antibody, with a similar profile to ALXN1210, represents the biggest competitive threat to Alexion, he contended.

PRICE ACTION

In Monday afternoon trading, shares of Ra Pharmaceuticals have dropped almost 40% to $8.80, while Alexion’s stock has gained about 3% to $112.37.


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Ironwood Pharmaceuticals reports positive results

Ironwood reports Phase IIa data for IW-1973 demonstrating positive effects 

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Ironwood reports Phase IIa data for IW-1973 demonstrating positive effects 

Ironwood Pharmaceuticals (IRWD) announced encouraging top-line results from two Phase IIa studies of IW-1973, Ironwood’s lead investigational soluble guanylate cyclase stimulator, in patients with type 2 diabetes and hypertension.

Consistent with pre-clinical observations, in both studies treatment with IW-1973 led to blood pressure reductions and improvements in metabolic parameters, including reductions in fasting plasma glucose and cholesterol levels, in patients who were taking a stable regimen of therapies to manage their disease.

Elevated levels of plasma cGMP provided clear evidence of target engagement. These studies confirm a pharmacokinetic profile of IW-1973 supporting once-daily dosing and suggest broad distribution to tissues, offering the potential for extra-vascular pharmacology. IW-1973 was generally well-tolerated.

Ironwood is currently developing IW-1973 for the treatment of diabetic nephropathy and for the treatment of heart failure with preserved ejection fraction.

The company recently initiated two new Phase II dose-ranging clinical trials with IW-1973 in these indications.

The two Phase IIa exploratory studies were designed to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics of IW-1973 in diabetic patients with hypertension on a stable regimen of medicines to manage their disease.

The studies were not designed or powered explicitly to assess efficacy, but the data yielded clear and consistent trends indicating a positive effect of IW-1973 on blood pressure, metabolic parameters and endothelial function biomarkers.

At day 14, patients treated with IW-1973 showed a mean decrease in mean arterial blood pressure of 6.3 mmHg from baseline compared to a decrease of 1.6 mmHg from baseline in patients treated with placebo, as measured by 24-hour ambulatory blood pressure monitoring, which was a 4.7% greater reduction in patients treated with IW-1973 compared to placebo-treated patients.

IRWD closed at $17.32.


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Hartford sells Talcott Resolution for $2.05 billion

Hartford Financial to sell Talcott Resolution to investors for $2.05B

Hartford Financial to sell Talcott Resolution to investors for $2.05B
Hartford Financial to sell Talcott Resolution to investors for $2.05B

The Hartford (HIG) has entered into a definitive agreement to sell Talcott Resolution, its run-off life and annuity businesses, to a group of investors led by Cornell Capital LLC, Atlas Merchant Capital LLC, TRB Advisors LP, Global Atlantic Financial Group, Pine Brook and J. Safra Group.

Total consideration to The Hartford is $2.05B, comprised of cash from the investor group, a pre-closing cash dividend, debt included as part of the sale, and a 9.7% ownership interest in the acquiring company. The total consideration amount does not include $1.4B in dividends previously paid by Talcott Resolution in 2017.

The sale is anticipated to close in the first half of 2018, subject to regulatory approval and other closing conditions.

Under the terms of the sale agreement and subject to regulatory approval, the investor group will form a new company that will purchase Hartford Life, the holding company for the Talcott Resolution operating subsidiaries, for a net payment of $1.443B in cash.

The Hartford will receive a 9.7% ownership interest, valued at $164M, in the new company.

Subject to regulatory approval, The Hartford also expects to receive $300M in a pre-closing dividend from Talcott Resolution and will reduce its long-term debt by $143M because debt issued by HLI will be included as part of the sale.

In addition, The Hartford will retain Talcott Resolution tax benefits with an estimated GAAP book value of $950M, which will be available for realization subject to the level and timing of The Hartford’s taxable income.

As a result of The Hartford’s election to retain certain tax benefits, the company will not recognize a tax capital loss on the sale.

Based on the terms of the sale and the retention of the tax attributes, The Hartford estimates that the sale will result in a GAAP net loss of approximately $3.2B, after tax, which would be recorded in discontinued operations in fourth quarter 2017.

The estimated loss on sale and the estimated retained tax benefits and our ability to realize such benefits are based on current tax law and are subject to a final determination of the tax basis of the operations sold.

Beginning in fourth quarter 2017 and continuing until closing of the transaction, the results of operations of Talcott Resolution will be reported as discontinued operations for all periods presented in The Hartford’s financial statements.

Prior to the closing of the transaction, the company’s Group Benefits and Mutual Funds subsidiaries, which are currently subsidiaries of HLI, will be transferred to another Hartford subsidiary and will not be part of the transaction.

In addition, immediately after closing, Talcott Resolution will reinsure a portion of its fixed annuity, payout annuity and structured settlement businesses to a subsidiary of Global Atlantic Financial Group.

Following the sale, Hartford Investment Management Company, The Hartford’s investment management group, will continue to manage a significant majority of Talcott Resolution’s investment assets for an initial 5-year term.

HIMCO also will be retained by Global Atlantic to manage certain assets associated with the post-closing reinsurance agreement. As part of the transaction, about 400 Hartford employees will become employees of the new company and will be located at offices currently owned or leased by The Hartford in Windsor, Connecticut, and Woodbury, Minnesota.

HIG closed at $57.43.


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CVS to buy Aetna for $77 billion

Aetna sold for $275 per share in cash and stocks

CVS offers $275 per share for Aetna.  

VS Health (CVS) and Aetna (AET) announced the execution of a definitive merger agreement under which CVS Health will acquire all outstanding shares of Aetna for a combination of cash and stock.

Under the terms of the merger agreement, Aetna shareholders will receive $145 per share in cash and 0.8378 CVS Health shares for each Aetna share. The transaction values Aetna at approximately $207 per share or approximately $69B. Including the assumption of Aetna’s debt, the total value of the transaction is $77B.

If approved, the mega-merger would create a giant consumer health care company with a familiar presence in thousands of communities. Aetna chief executive Mark T. Bertolini described the vision in an interview as “creating a new front door for health care in America.”

CVS would provide a broad range of health services to Aetna’s 22 million medical members at its nationwide network of pharmacies and walk-in clinics, and further decrease the drug store titan’s reliance on the retail sales that have faced increasing competition.

“You can imagine a world where health care is better designed around the people who use it, which is one of the challenges we have today,” CVS chief executive Larry J. Merlo said in an interview. As part of the deal, Bertolini would join the CVS board and Aetna would be run as a standalone business unit.

The deal is likely to set off even more mergers in the health-care industry, which has been undergoing consolidation and faces potential new competition from Amazon.

It could position Aetna to be more competitive with UnitedHealth Group, the nation’s largest insurer, which has already expanded  beyond its core business into pharmacy care services, clinics and surgery care centers and health care data.

CVS closed at $75.12. AET closed at $181.31.


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Barron’s is bullish on Salesforce.com

Barron’s, the weekly publication owned by the Wall Street Journal, in its latest issue mentions several names: 

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BULLISH  MENTIONS

Johnson & Johnson (JNJ) could rise further – In a follow-up story, Barron’s notes that Johnson & Johnson’s shares had a blockbuster year, as concerns about its big rheumatoid-arthritis drug Remicade proved too pessimistic, but shares could rise almost 20% as investors view the company’s drug pipeline in a new light.

Companies trading mostly in U.S. to benefit from tax reform – Investors in companies that trade mostly in the U.S. such as Southwest Airlines (LUV) should benefit greatly from what is arguably the signature provision of the tax reform bill, namely a drop in the federal corporate tax rate, John Kimelman writes in this week’s edition of Barron’s. Tech giants such as Apple (AAPL), Microsoft (MSFT) and Alphabet (GOOG; GOOGL) should experience a huge windfall from the legislation’s provision that could set the rate on the taxes of foreign earnings held in cash as low as 10%, thus encouraging repatriation, he says.

Transfer Partners situation to be resolved by 2019/2020 – Master limited partnerships have been dogged for the past several years by investor concerns, with Energy Transfer Partners (ETP) being one of the worst-performing large MLPs, Andrew Bary writes in this week’s edition of Barron’s. Its unit price has tumbled since the merger with Sunoco Logistics, even as the units of its sister company, Energy Transfer Equity (ETE) have held steady, he adds. The endgame probably will be a merger of the two companies, or an equity buyout of the IDRs by Energy Transfer Partners, Barron’s contends.

Start-ups dwelling in tech giants shadow – Tech giants such as Amazon (AMZN), Alphabet (GOOG; GOOGL) and Apple (AAPL) show no signs of slowing down, increasingly calling the shots in tech in a way that limits the scope within which small companies operate, Tiernan Ray writes in this week’s edition of Barron’s. While many start-ups show promise but “dwell in the shadow of the giants,” he adds. Commenting on recent IPOs, Barron’s notes that while Appian (APPN) and Roku (ROKU) have surged 39% and $85% respectively, cloud-computing darlings Mulesoft (MULE) and Tintri (TNTR) are down since their debuts.

Wall Street about to join in Bitcoin fun – Bitcoin shot past $11,000 last week but slid sharply right after before surging yet again, Avi Salzman writes in this week’s edition of Barron’s. Now Wall Street is about to join in the fun, he notes, adding that getting listed on some of the largest exchanges in the country is a “tectonic shift for Bitcoin.” Banks like Goldman Sachs (GS) are considering helping clients execute Bitcoin trades, and once “they dip their toes in,” there may be no turning back, Salzman contends.

 Salesforce.com has 25% upside – As Salesforce (CRM) launches new products, its “addressable market” expands, which means more opportunities for sales and potentially wider margins, Jack Hough writes in this week’s edition of Barron’s. The company’s shares should continue to outperform as revenue rises and margins improve, and a 25% increase in 2018 to $130 seems achievable, he adds.


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Rig counts continue to rise

Baker Hughes reports U.S. rig count up 6 to 929 rigs 

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Baker Hughes reports that the U.S. rig count is up 6 rigs from last week to 929, with oil rigs up 2 to 749, gas rigs up 4 to 180, and miscellaneous rigs unchanged.

The U.S. Rig Count is up 332 rigs from last year’s count of 597, with oil rigs up 272, gas rigs up 61, and miscellaneous rigs down 1 to 0.

The U.S. Offshore Rig Count is down 2 rigs from last week to 20 and down 2 rigs year-over-year.

The Canada Rig Count is up 7 rigs from last week to 222, with oil rigs up 4 to 111 and gas rigs up 3 to 111, and miscellaneous rigs unchanged.

The Canada Rig Count is up 22 rigs from last year’s count of 200, with oil rigs up 11, gas rigs up 13, and miscellaneous rigs down 2 to 0.

Crude oil is up 85 cents to $58.25 per barrel.  Brent crude is up $1.01 to $63.64 per barrel.


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CME and CBOE to offer Bitcoin options

CFTC to allow CME, CBOE to launch bitcoin products

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CBOE and CME to offer Bitcoin Options

The U.S. Commodity Futures Trading Commission noted that the Chicago Mercantile Exchange (CME) and the CBOE Futures Exchange (CBOE) self-certified new contracts for bitcoin futures products, and the Cantor Exchange self-certified a new contract for bitcoin binary options.

CFTC Chairman J. Christopher Giancarlo said regarding the news:

“Bitcoin, a virtual currency, is a commodity unlike any the Commission has dealt with in the past. As a result, we have had extensive discussions with the exchanges regarding the proposed contracts, and CME, CFE and Cantor have agreed to significant enhancements to protect customers and maintain orderly markets.

In working with the Commission, CME, CFE and Cantor have set an appropriate standard for oversight over these bitcoin contracts given the CFTC’s limited statutory ability to oversee the cash market for bitcoin.

Market participants should take note that the relatively nascent underlying cash markets and exchanges for bitcoin remain largely unregulated markets over which the CFTC has limited statutory authority.

There are concerns about the price volatility and trading practices of participants in these markets. We expect that the futures exchanges, through information sharing agreements, will be monitoring the trading activity on the relevant cash platforms for potential impacts on the futures contracts’ price discovery process, including potential market manipulation and market dislocations due to flash rallies and crashes and trading outages. Nevertheless, investors should be aware of the potentially high level of volatility and risk in trading these contracts.”

Once the contracts are launched, Commission staff will engage in a variety of risk-monitoring activities.

As trading on these DCMs evolves, the Commission will continue to assess whether further changes are required to the contract design and settlement processes and work with the DCMs to effect any changes, the CFTC added.

CME closed at $149.54.


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Apple launches Heart Study app

Apple, Stanford University partner to launch Apple Heart Study app 

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Apple launches Heart Study App

Apple (AAPL) yesterday launched the Apple Heart Study app, a first-of-its-kind research study using Apple Watch’s heart rate sensor to collect data on irregular heart rhythms and notify users who may be experiencing atrial fibrillation.

To calculate heart rate and rhythm, Apple Watch’s sensor uses green LED lights flashing hundreds of times per second and light-sensitive photodiodes to detect the amount of blood flowing through the wrist.

The sensor’s unique optical design gathers signals from four distinct points on the wrist, and when combined with powerful software algorithms, Apple Watch isolates heart rhythms from other noise.

The Apple Heart Study app uses this technology to identify an irregular heart rhythm. Apple is partnering with Stanford Medicine to perform the research.

As part of the study, if an irregular heart rhythm is identified, participants will receive a notification on their Apple Watch and iPhone, a free consultation with a study doctor and an electrocardiogram patch for additional monitoring.

The Apple Heart Study app is available in the US App Store to customers who are 22 years or older and have an Apple Watch Series 1 or later.

AAPL closed at $171.85.


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