Showing posts with label Breaking news. Show all posts
Showing posts with label Breaking news. Show all posts

Tuesday, September 5, 2017

Here's Why Insmed Incorporated Is Skyrocketing

Here's Why Insmed Incorporated Is Skyrocketing

What happened

Investors in Insmed (NASDAQ: INSM) are having an incredible start to the short trading week. Shares of the rare disease focused biotech are up 110% as of 11:15 a.m. EDT, after the company announced upbeat top-line results from its phase 3 Convert trial.

So what

The Convert trial was designed to measure the effect of adding Insmed's drug Amikacin Liposome Inhalation Suspension (ALIS) to guideline-based therapy (GBT) in patients who have treatment-refractory nontuberculous mycobacterial (NTM) lung disease caused by mycobacterium avium complex.
Data from the 336-patient trial showed that ALIS was able to meet its primary endpoint. Specifically, the study showed that adding ALIS to guideline-based therapy eliminated evidence of NTM lung disease by month 6 in 29% of patients. That was a statistically significant increase when compared to the 9% of patients who received GBT alone.
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This data was so encouraging that Insmed plans on pursuing accelerated approval for ALIS. The therapy has also already been granted both "breakthrough therapy" designation and fast-track status by the U.S. Food and Drug Administration.
Insmed's CEO Will Lewis stated:
We consider these compelling top-line data to be a remarkable accomplishment in a rare disease state with no currently approved therapies. We are particularly encouraged by the consistency of these data when compared with our Phase 2 study results and look forward to additional data as the CONVERT study continues over the next two years.
Given the upbeat clinical news, it is easy to understand why investors are cheering today.
Image source: Getty Images.

Now what

The only potential wrinkle in the data related to the drug's safety. The dropout rate for patients who used ALIS and GBT was 19.6%, which was a fair bit higher than the 9% dropout rate observed in the GBT group alone. Management stated that safety issues "were predominately mild or moderate in nature and generally declined after the second month of treatment."
To give investors more context on this issue, Dr. Paul Streck, Insmed's chief medical officer, offered this commentary:
The current guideline-based therapy to which we were compared in this study is not approved for the treatment of this disease, but is generally regarded as the best available option for these patients. Our drug candidate, ALIS, delivers high levels of an aminoglycoside directly to the lung macrophages and pulmonary tissue where the infection resides, and we believe this accounts for the significant impact on conversion that the drug demonstrated in these trial results.
All in all, today's clinical update clearly provides investors with reasons to be bullish on the future of Insmed. Risk-loving investors might want to consider putting this small-cap biotech on their watchlist.
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Friday, September 1, 2017

Wall Street Breakfast: Investors Ready For Jobs Report

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 Includes: AAPLAMZNBHPFDXHPELULUMCFYYQQQSIXSPY,

U.S. job growth likely slowed in August after two straight months of robust gains, but the pace of increase should be more than sufficient for the Fed to start shrinking its massive bond portfolio. Today's non-farm payrolls report will probably show around 180,000 additions to the workforce, with average hourly earnings rising 0.2%, while the unemployment rate is expected to remain unchanged at 4.3%.
Economy
The death toll from Tropical Storm Harvey has risen to 44, and the storm could wind up being the most expensive natural disaster in American history. It could cost the economy about $190B, according to AccuWeather, which predicts it will total more than Katrina and Sandy combined. "You had the greatest rainfall ever measured in the continental U.S... damage to the supply chain across the country, jobs lost and health problems."
The Trump administration has a "very detailed" tax plan ready and "couldn't be more excited" about its prospects, according to Treasury Secretary Steven Mnuchin, who added that the debt ceiling issue won't hold America back. "Details will come out later this month, it's going to go through a committee process, and we expect the House and the Senate will get this to the president to sign this year."
The Federal Reserve's board of governors will conduct an open meeting today to discuss the "final rule establishing restrictions on qualified financial contracts of systemically important U.S. banking organizations" and the "U.S. operations of systemically important foreign banking organizations." It will take place at the Marriner S. Eccles Federal Reserve Board Building in Washington, D.C.
Mexico and Canada would remain in NAFTA even if the Trump administration abandoned the deal, Mexican Economy Minister Ildefonso Guajardo declared, noting that only the U.S. might consider leaving the accord. The statement comes as the second round of NAFTA negotiations begins in Mexico City, with the three countries pushing to modernize the 23-year-old trade agreement.
Slipping against the dollar and flat against the euro, sterling is on track to record its worst month since October, as Brexit uncertainty weighs on the currency. EU and U.K. teams agreed that "no decisive progress" had been made in the latest round of Brexit talks, with the EU's chief negotiator, Michel Barnier, criticizing the U.K. for "demanding the impossible."
Echoing the similar robust official data reported yesterday, Caixin/Markit's China Manufacturing PMI rose to 51.6 in August, compared with 51.1 in July. Total new business grew at the strongest rate in more than three years, while export orders saw the sharpest increase in over seven years, pointing to strong demand at home and abroad.
Iran is sticking by its nuclear deal with world powers by keeping its uranium stockpile and production capacity below set thresholds. The report, published by the International Atomic Energy Agency, is the third since the inauguration of President Trump in January. Is sanctions relief for Tehran and business with the Islamic Republic set to continue?
Russia has yet to study the U.S. decision to shut its consulate in San Francisco before considering possible retaliation, Foreign Minister Sergey Lavrov declared at the country's top diplomacy school. The Trump administration just gave Russia 72 hours yesterday to close three of its diplomatic facilities in America in retaliation for kicking out more than 700 U.S. diplomats last month.

Stocks
Some Texas operations crippled by Hurricane Harvey are back online as UPSand FedEx (NYSE:FDX) restarted flights at Houston's main airport. "The safety of our employees comes first and we will be resuming service as soon as it is safe to do so," said UPS spokesman Matt O'Connor. Two days ago, the storm stopped or sharply limited deliveries to more than 730 zip codes in Texas and Louisiana.
Amazon is working on plans to roll out its one- and two-hour membership delivery service into Canada later this year, a move that marks a broader push into the country by the retailer, WSJ reports. If the initial launch in Vancouver and Toronto is successful, Amazon (NASDAQ:AMZN) will consider expanding its Prime Now service to various Canadian cities in 2018.
According to a letter dated Aug. 11, the head of Western Digital (NYSE:WDC) apologized to Toshiba's (OTCPK:TOSYY) CEO for strained ties after it sued to keep their memory chip joint venture from being sold to rival bidders. Stephen Milligan also said the U.S. firm would address any concerns that Apple (NASDAQ:AAPL), a key customer of Toshiba's NAND flash memory chips, might have if a deal was struck with Western Digital.
Samsung is the latest company to get the go-ahead to test self-driving cars on California's public roads. In a statement to Reuters, Samsung (OTC:SSNLF) did not say what precisely what it planned to test in the U.S., but said it secured the permit "in pursuit of a smarter, safer transportation future." It also has "no plans to enter the car-manufacturing business."
Tesla's Gigafactory in Buffalo has started making solar cells for roofs, according to Bloomberg. "Like the vehicle production ramp, this starts off extremely slowly, but ramps up exponentially over time," said a spokesperson. Tesla (NASDAQ:TSLA) aims to reach 2 gigawatts of cell production annually at the plant, up from an original target of 1 gigawatt by 2019.
On the hook... Verizon's (NYSE:VZ) efforts to contain liability related to a massive data breach at Yahoo (now its subsidiary) hit a snag after a judge ruled Yahoo must face related litigation. "All plaintiffs have alleged a risk of future identity theft, in addition to loss of value of their personal identification information," said U.S. District Judge Lucy Koh.
Hewlett Packard Enterprise -20% premarket after completing the spinoff of much of its software business, which will merge with Britain's Micro Focus (OTC:MCFYY). The step marks the end of HPE's unhappy tangle with Autonomy, which it acquired for $11B to transform into an enterprise software leader. The ink was barely dry on the much-criticized deal when the company took an $8.8B writedown on it.
Standing at about 100 ft. tall, Six Flags (NYSE:SIX) has announced the world's largest "loop coaster," which is scheduled to open at its Great America amusement park in 2018. Six Flags shares have been on a roller coaster of their own this year. The stock rose about 10% since January to a peak of $65 in April, but has since plunged 15% on a not-so-thrilling ride.
There's seems to be an ETF for everything nowadays. A planned index fund is hoping to "make America great again" by investing in companies that support the Republican Party. The Point Bridge GOP Stock Tracker exchange-traded fund will list next month under the ticker "MAGA," catering to people hoping to express their social or political views when they invest.
A rare rebuke from the bank's second-largest shareholder... Vanguard voted against three directors at Wells Fargo (NYSE:WFC) this year, including Chairman Stephen Sanger, according to U.S. filings. The lack of support was disclosed as Wells announced it had uncovered more than a million additional accounts opened without clients' authorization, marking a 70% increase over the bank's initial estimate.
Elliott Management has raised its stake in BHP Billiton (NYSE:BHP) to 5%, stepping up a campaign to pressure the miner into boosting returns, ditching its dual listing and quitting its U.S. shale business. Under English company law, the threshold gives a shareholder the right to requisition a general meeting and circulate a resolution on which other investors can vote.
More than 200 companies are believed to have submitted designs for the proposed border wall, but the Trump administration has selected only four private firms to build initial prototypes. They include Caddell Construction, Fisher Sand & Gravel, Texas Sterling Construction and W.G. Yates & Sons. The models will be 30 feet tall, about 30 feet wide and will be tested in San Diego.
Thursday's Key Earnings
Lululemon (NASDAQ:LULU+5.4% AH lifting guidance.
TD Bank (NYSE:TD+4.4% beating estimates.
Today's Markets 
In Asia, Japan +0.3%. Hong Kong -0.1%. China +0.2%. India +0.5%.
In Europe, at midday, London +0.2%. Paris +0.9%. Frankfurt +0.8%.
Futures at 6:20, Dow +0.2%. S&P +0.2%. Nasdaq +0.2%. Crude -1.1% to $46.71. Gold +0.1% to $1323.80.
Ten-year Treasury Yield +1 bps to 2.13%
Today's Economic Calendar
Companies reporting earnings today »

Thursday, August 31, 2017

Top 10 Medical Innovations for 2017 Revealed


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Now in its 14th year, Cleveland Clinic’s Medical Innovation Summit is the oldest and largest meeting of its kind in healthcare. The perennial highlight? The unveiling of the top 10 medical advancements for the coming year — those that Cleveland Clinic experts predict will change patient care forever.
Here are their picks for 2017, in order of anticipated importance:

1. Using the microbiome to prevent, diagnose and treat disease

Microbes in our bodies — and the chemicals they emit — interfere with the way food is digested, medicine is deployed and even how a disease progresses.
Biotech companies once focused on the genomic market are pivoting to the potential of the microbiome to develop new diagnostics, new therapies and “probiotic” products to prevent dangerous microbe imbalances.
With the National Microbiome Initiative’s accelerating research and development, experts believe 2017 is the year the microbiome becomes the healthcare industry’s most promising and lucrative frontier.

2. Diabetes drugs that reduce cardiovascular disease and death

Half of patients with Type 2 diabetes will die from complications of cardiovascular disease. On their 65th birthdays, the odds go up to 70 percent.
In 2016, two new medications began reducing the mortality rates considerably. Empagliflozin modifies the progression of heart disease by working with the kidney while liraglutide has a comprehensive effect on many organs.
Given these positive results, experts predict 2017 will mark a complete shift in the lineup of medicines prescribed for diabetes patients — as well as a wave of research into new avenues targeting Type 2 diabetes and its comorbidities.

3. Cellular immunotherapy to treat leukemia and lymphomas

One of the first cellular immunotherapies for leukemia and non-Hodgkin lymphomas is about to hit the market. Chimeric antigen receptor T-cell therapies are a type of immunotherapy where a patient’s immune system T-cells are removed and genetically reprogrammed to seek and destroy tumor cells.
Results have been impressive. Some studies focusing on acute lymphoblastic leukemia (ALL) have reported a remission rate of 90 percent.
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This groundbreaking treatment is expected to be presented to the FDA in 2017 for treatment of ALL. That could trigger a wave of approvals for other blood cancers and lymphomas as well. Cellular immunotherapy could one day replace chemotherapy and its lifetime of side effects.

4. Liquid biopsies to find circulating tumor DNA

Tests known as “liquid biopsies” uncover signs of actual DNA, or cell-free circulating tumor DNA (ctDNA), which is shed from a tumor into the bloodstream. This ctDNA is more than 100 times more abundant in the blood than tumor cells.
While studies are still underway, annual sales of this revolutionary cancer test are forecast to be $10 billion. Several companies are developing testing kits to hit the market this year.
Liquid biopsy is being hailed as a flagship technology of the federal government’s Cancer Moonshot Initiative. Experts believe it’s only a matter of time before catching and treating cancer is as routine as an annual checkup.

5. Automated car safety features and driverless capabilities

With more than 38,000 fatal car crashes in the U.S. in 2015, automobile accidents remain a leading cause of death and disability — not to mention a major expense. Annual medical costs are nearly $23 billion.
New automatic safety features promise to make a dent in dangerous car accidents. These range from collision warning systems to drowsiness alerts to adaptive cruise control. More are coming. Safety technology is expected to surge in 2017, a year before the U.S. Department of Transportation mandates backup cameras in all cars.
Meanwhile, there is a grander notion to remove all human error from vehicle transportation. The nation’s biggest software, private transportation and auto manufacturing companies are making huge investments in driverless cars. Safety and legal questions remain, but 2017 is expected to be the year that driverless cars enter the mainstream.

6. Fast Healthcare Interoperability Resources

It has become increasingly difficult to safely and efficiently share patient data between healthcare providers. In-house information technology (IT) systems have become so diverse, that it’s hard for them to communicate with each other.
FHIR (Fast Healthcare Interoperability Resources), a new tool developed according to Health Level Seven (HL7) standards, will act as an interpreter between two healthcare systems or offices. The first release will focus on clinical data, like images and medications, while the second will focus on administrative data, like billing and demographics.
FHIR blazes the way for a surge of life-saving health information technology.

7. Ketamine for treatment-resistant depression

For one-third of U.S. patients with depression, standard medications aren’t enough. With nearly 43,000 suicides a year, the need for effective treatment looms large.
In 2013, ketamine, a drug commonly used for anesthesia, was studied for its ability to target and inhibit the action of N-methyl-D-aspartate (NMDA) receptors of nerve cells. The results were overwhelmingly favorable. Studies indicated that 70 percent of patients with treatment-resistant depression saw an improvement in symptoms within 24 hours of receiving ketamine. For the first time, there was a fast treatment for the severely depressed.
The studies prompted the FDA to grant fast-track status for the development of new NMDA-receptor-targeting medications. Some, like esketamine, have received breakthrough designation from the FDA, making it more likely that they will become available to patients in 2017.

8. 3-D visualization and augmented reality for surgery

Surgeons rely on microscope oculars or other camera systems to operate. However, they typically depend on their own eyes and interpretations to execute the most precise tasks — with their heads down, peripheral vision limited, and back and neck muscles strained.
This past year, two of the most intricate surgical fields, neurosurgery and retinal microsurgery, began experimenting with technology that keeps surgeons’ heads up while immersing them in a high-resolution, 3-D visual representation of their subject. These stereoscopic systems also use data to generate visual templates for surgeons to execute certain tasks.
Those who have piloted the technology say the added comfort and visual information will allow surgeons to operate more efficiently and effectively. Several hospitals will be adopting these virtual reality tools in 2017.

9. Self-administered HPV test

Most sexually active women contract human papillomavirus (HPV). Certain strains of HPV are responsible for 99 percent of cases of cervical cancer.
Despite great strides in HPV prevention and treatment, the benefits are restricted to a small population — women with access to HPV tests and vaccines.
To expand access, scientists have developed self-administered HPV test kits that include a test tube, a swab and a mail-in box. Women can administer their own test, mail a sample back to a lab and be alerted to dangerous strains of HPV.
Experts believe 2017 will be the year these tests are deployed on a large scale, representing the biggest prevention effort for cervical cancer to date.

10. Bioabsorbable stents

Every year, 600,000 people have metal coronary stents put into their chests to treat coronary artery blockage. Most of the time, that stent stays there forever, long after its mission is complete. The stents can make some scans and future surgeries difficult and may cause other complications, like blood clots.
But what if they could just disappear?
This past July, the first bioabsorbable stent was approved in the United States. Made of a naturally dissolving polymer, the stent widens the clogged artery for two years before it is absorbed into the body in a manner similar to dissolvable sutures.
Experts believe the market potential of bioabsorbable stents will approach $2 billion within six years.
Source: https://goo.gl/T2tzEM

Monday, August 28, 2017

Wall Street Breakfast: Harvey Swamps U.S. Energy Engine

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Includes: ALLAPCBABPLBRK.ABRK.BCBSCOPEXPEGEKKR,

Energy markets were roiled overnight after Hurricane Harvey wreaked havoc along the U.S. Gulf coast, knocking out numerous refineries as well as some oil production. Gasoline futures surged to their highest in two years, climbing over 7% to $1.7799 a gallon, while crude futures fell by half a dollarto $47.42/bbl, as the refinery shutdowns could reduce demand for American oil. Among those affected: XOMVLOCOPNBLAPCBPLMMPPSXPBRRDS.ARDS.B
Economy
"Damages from Harvey... are estimated to be well below those from major storms that have hit New Orleans and New York," according to one of the world's largest reinsurers. Hannover Re said that insured losses for Katrina in 2005 were around $80B, while losses from Sandy in 2012 were $36B. Top insurers in Texas include: ALLBRK.ABRK.B
Britain's talks on leaving the EU will resume today amid a deepening standoff over the U.K.'s financial obligations. Brexit Secretary David Davis is calling for "flexibility and imagination" to break the deadlock, but the EU will likely find it difficult to make progress until it has agreed on a sum for the divorce. Only two more rounds of Brexit talks are scheduled for Sept. 28 and Oct. 9.
President Trump recently dismissed some of his senior staff as globalists and demanded that someone draw up a plan for tariffs that would affect China, according to a leaked account by Axios. "China is laughing at us," he said at a trade meeting in the Oval Office. "I want tariffs. And I want someone to bring me some tariffs."
North Korea fired several ballistic missiles off its east coast on Saturday that flew for about 155 miles, as the South and U.S. conducted their annual joint military drills. On Friday, China's commerce ministry also banned North Korean individuals and enterprises from doing new business in China, in line with UN sanctions passed earlier this month.
Colombia's leftist FARC rebels will seek political rebirth this week as they move to transform into a party after disarming to end a half-century war. The country's economy is already doing well, but the peace deal may lead to a 3% increase in GDP, according to experts. Tourism is booming, while the country is rich in commodities and exports flowers and coffee.
India and China have agreed to an "expeditious disengagement" of troops in the disputed Doklam region, where their soldiers have been locked in a stand-off since June. The decision comes ahead of next week's summit of BRICS nations - a grouping that also includes Brazil, Russia and South Africa. The bloc has created a $100B development bank and a $100B emergency fund.

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Stocks
Following months of speculation, UBER has decided to appoint Expedia's (NASDAQ:EXPE) Dara Khosrowshahi as chief executive officer, according to numerous sources. He'll take on the daunting task of mending Uber's image, repairing frayed relations among investors, rebuilding employee morale and creating a profitable business after seven years of losses.
General Electric wants its industrial software business to cut costs and lift profits next year under new CEO John Flannery, and is considering expanded partnerships and the possible sale of some equity in the unit, Reuters reports. GE now expects $12B in digital revenue in 2020, compared with $15B, due to technical problems and delays with its software platform, known as Predix.
Ending months of dispute over the auction, Western Digital (NYSE:WDC) CEO Steve Milligan is visiting Japan to finalize an agreement to buy Toshiba's (OTCPK:TOSYY) memory chip business. Key members of the consortium also include KKR, INCJ and the Development Bank of Japan. They hope to conclude the deal by the end of this month.
More chip investment... Samsung Electronics (OTC:SSNLF) expects to spend $7B over the next three years to expand its NAND memory production in China's northwestern city of Xi'an. In early July, Samsung announced an investment of $18.6B in South Korea, riding a wave of record profits amid a memory chip boom.
A search effort is underway after an American Black Hawk (NYSE:LMT) helicopter went down off Yemen's southern coast during a training exercise. It's the latest in a string of U.S. military crashes. Another Black Hawk went down off Hawaii this month, as well as a Marine MV-22 Osprey (BATXT) in Australia, while a KC-130T Hercules crashed in Mississippi in July.
A great rollout? "We're doing everything we can to make sure everyone who wants to buy a Nintendo Switch system can do so. We will ramp up production for the holiday period," Nintendo (OTCPK:NTDOY) told the WSJ. Nintendo's official target is to ship 10M Switch units in its current fiscal year ending in March 2018, but supply chain sources said they have been told to prepare for 18M units.
More foreign streaming services are headed Down Under after CBS agreed to acquire Australian broadcaster Ten Network. Neither party disclosed details of the deal, but analysts and local media valued it at A$200M-A$250M. The move thwarts a takeover by a consortium led by Lachlan Murdoch - co-chair of CBS rival News Corp. (NASDAQ:NWS) - after Ten went into receivership.
Viewers from all over the country missed parts - if not most - of Floyd Mayweather's 10th-round knockout of Conor McGregor on Saturday night. When asked about refunds, Leonard Ellerbe, CEO of Mayweather Promotions, responded "these things happen." Whatever the case may be, it's expected to be a major payday for Showtime (NYSE:CBS) - PPV revenue figures will be released in about a week.
Today's Markets 
In Asia, Japan flat. Hong Kong +0.1%. China +0.9%. India +0.5%.
In Europe, at midday, London -0.1%. Paris -0.4%. Frankfurt -0.6%.
Futures at 6:20, Dow -0.1%. S&P -0.1%. Nasdaq -0.1%. Crude -1.1% to $47.33. Gold +0.4% to $1302.40.
Ten-year Treasury Yield flat at 2.17%
Today's Economic Calendar
Companies reporting earnings today »